cambridge healthtech institute’s 5th … healthtech institute’s 5th annual powering next...

C A M B R I D G E H E A LT H T E C H I N S T I T U T E ’ S 5 T H A N N U A L

Powering Next Generation Targeted Immunotherapies

S U M M I TImmuno-Oncology

P R E M I E R S P O N S O R

AUGUST 28 - SEPTEMBER 1, 2017 • SHERATON BOSTON HOTEL • BOSTON, MA

Immuno-OncologySummit.com

#IOSummit

Graeme E. Price, Ph.D. Research Microbiologist, Gene Transfer & Immunogenicity, FDA CBER

Gergana Zlateva, Ph.D. Vice President, Payer Insights and Access, Oncology, Pfizer

A Division of Cambridge Innovation Institute

FINAL WEEKS TO REGISTER!

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Conference-at-a-Glance

Short Courses

Sponsor & Exhibit Opportunities

Hotel & Travel Information

Registration Information

Click Here to Register Online!


Plenary Keynotes

Development

Translational IO

Therapy

Biomarkers

Vaccines

Training Seminar

Faculty

Plenary Keynote SpeakersEvent Features• 12 conference tracks – the most comprehensive

coverage in the industry• 3 short courses for more in-depth coverage of

emerging IO topics• Training Seminar for those new to the field:

Immunology for Drug Discovery Scientists• Over 500 senior-level attendees from biotech, pharma,

academia, and government

http://Immuno-OncologySummit.com

https://www.linkedin.com/groups/8507031

https://www.youtube.com/user/CambridgeHealthtech/

https://twitter.com/CHI_Healthtech

https://chidb.com/reg/imx/reg.asp

Immuno-Oncology Summit | 2

Immunomodulatory Therapeutic Antibodies for Cancer

CONFERENCE AT-A-GLANCE

Rational Combination Cancer Immunotherapy

Emerging Techniques in Synthetic Biology

Preclinical and Translational Immuno-Oncology

Development

Translational IO

Therapy

Biomarkers

Vaccines

MONDAY-TUESDAY AUGUST 28-29

TUESDAY-WEDNESDAY AUGUST 29-30

THURSDAY-FRIDAY AUGUST 31-SEPTEMBER 1

Immunology for Drug Discovery Scientists

Oncolytic Virus Immunotherapy

Adoptive T Cell Therapy

Quantitative Immune Profiling and Immune Monitoring

Biomarkers for Immuno-Oncology

Personalized Cancer Vaccines and Neoantigen Targeted Therapies



Advances in Vaccine Technologies Vaccine Adjuvants

Ts Emerging Immuno-Oncology Targets

S U M M I TImmuno-OncologyMEET THOUGHT LEADERS IN CANCER IMMUNOTHERAPY AT THE PREMIER ANNUAL IO EVENT

The Immuno-Oncology Summit will return to Boston again this August 28-September 1 with the goal of supporting researchers in developing the next generation of immunotherapies. Immuno-oncology researchers are changing the way we treat cancer by unleashing the immune system and achieving functional cures in some cancers. This year’s IO Summit has been designed to give attendees a complete picture of the field and its advances with

12 conference tracks, 1 in-depth training seminar, and 4 instructional short courses. Topics include immunotherapy discovery, development, biomarkers, and translational oncology as well as emerging topic areas such as cancer vaccines, oncolytic viruses, and advances in synthetic biology techniques. Overall, this event provides a focused look at how researchers are applying new science and technology in the development of effective and safe immunotherapies.

Who Will Attend? Scientific leaders, C-level executives, professors, site directors and researchers from pharma, biotech, academia, and government working in the areas of immuno-oncology, immunotherapy, antibody and protein engineering, biomarker discovery, immunology, cell and gene therapy, and preclinical and clinical development.



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Plenary Keynotes

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Vaccines

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Sponsors

C O R P O R AT E S P O N S O R S

C O R P O R AT E S U P P O R T S P O N S O R S

View Current Exhibitor List & Floor Plan

P R E M I E R S P O N S O R



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Plenary Keynotes

Development

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Therapy

Biomarkers

Vaccines

Training Seminar

Faculty

http://www.immuno-oncologysummit.com/uploadedFiles/Immuno_Oncology_Summit/Sponsor_and_Exhibits/IMX-Floorplan.pdf



Sponsorship, Exhibit & Lead Generation Opportunities

Podium Presentations — Available within Main Agenda!Showcase your solutions to a guaranteed, targeted audience through a 15- or 30-minute presentation during a specific conference program, breakfast, lunch, or separate from the main agenda within a pre-conference workshop. Package includes exhibit space, on-site branding, and access to cooperative marketing efforts by CHI. For the luncheon option, lunches are delivered to attendees who are already seated in the main session room. Presentations will sell out quickly, so sign on early to secure your talk!

One-on-One MeetingsSelect your top prospects from the pre-conference registration list. CHI will reach out to your prospects and arrange the meeting for you. A minimum num-ber of meetings will be guaranteed, depending on your marketing objectives and needs. A very limited number of these packages will be sold.

Reception / VIP Dinner / Hospitality SuiteSponsors will select their top prospects from the conference pre-registration list for an evening of networking at the hotel or at a choice local venue. CHI will extend invitations and deliver prospects, helping you to make the most out of this invaluable opportunity. Evening will be customized according to sponsor’s objectives. (i.e.: Purely social, Focus group, Reception style, Plated dinner with specific conversation focus)

Branding & Promotional Opportunities Include:• Floor Standing Meter Boards• Badge Lanyards• Exhibit Hall Reception• Conference Tote Bags• Hotel Room Keys• Program Guide Advertisement

ExhibitExhibitors will enjoy facilitated networking oppor-tunities with qualified delegates. Speak face-to-face with prospective clients and showcase your latest product, service, or solution.

Looking for additional ways to drive leads to your sales team?CHI’s Lead Generation Programs will help you to obtain more targeted, quality leads throughout the year. We will mine our database of over 1,000,000 life science professionals to meet your specific needs. We guarantee a minimum of 100 leads per program! Opportunities include:

• White Papers• Webinar• Custom Market Research Survey• Podcasts

CHI offers comprehensive sponsorship packages which include presentation opportunities, exhibit space, branding and networking with specific prospects. Sponsorship allows you to achieve your objectives before, during, and long after the event. Any sponsorship can be customized to meet your company’s needs and budget. Signing on early will allow you to maximize exposure to qualified decision-makers.

For additional sponsorship & exhibit information, please contact:Rod EymaelManager, Business Development T: (+1) 781-247-6286 E: [email protected]

COMPANY TYPE

Biotech + Pharma 71%Academic/Government 12%Healthcare 11%CRO 2%Financial 2%Other 2%

GEOGRAPHIC LOCATION

USA 77%US Breakdown East Coast 58%West Coast 32%Midwest 10%

Europe 15%Asia 6%Rest of World 2%

2016 Attendee Demographics

DELEGATE TITLE

Executive & Director 43%Scientist/Technologist 20%Manager 13%Sales & Marketing 12%Professor 12%

REGISTER AS AN EXHIBITOR HERE!

View Current Exhibitor List & Floor Plan



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Plenary Keynotes

Development

Translational IO

Therapy

Biomarkers

Vaccines

Training Seminar

Faculty

http://www.immuno-oncologysummit.com/uploadedFiles/Immuno_Oncology_Summit/Sponsor_and_Exhibits/IMX-Exhibit-Contract.pdf

http://www.immuno-oncologysummit.com/uploadedFiles/Immuno_Oncology_Summit/Sponsor_and_Exhibits/IMX-Floorplan.pdf



Distinguished Faculty

Margie Ackerman Ph.D., Assistant Professor, Engineering, Dartmouth College

Gregory AdamsPh.D., CSO, Eleven Biotherapeutics

Adam J. AdlerPh.D., Professor, Immunology, University of Connecticut

Martha Alexander-MillerPh.D., Chair & Professor, Microbiology & Immunol-ogy, Wake Forest School of Medicine

Maher AlbitarMD, SVP, Chief Medical Of-ficer & Director, Research & Development, NeoGenomics Laboratories, Inc.

Soner AltiokMD, Ph.D., CSO, Nilogen Oncosystems

Robert AndersM.D., Ph.D., Associate Professor, Pathology, Johns Hopkins University

David E. AndersonPh.D., CSO, VBI Vaccines

Philip M. ArlenM.D., President & CEO, Precision Biologics, Inc.

Deepti Aurora-GargPh.D., Director, Companion Diagnostics, Merck

Justin Balko Pharm.D., Ph.D., Assistant Professor, Medicine & Cancer Biology, Vanderbilt University School of Medicine; Leader of Molecular Oncology, Center for Cancer-Targeted Therapies, Vanderbilt Ingram Cancer Center

Xingfeng BaoPh.D., Senior Principal Scientist & Head, Immuno-Oncology, Andover Innovative Medicine Institute, Eisai

Glen N. BarberPh.D., Professor & Chair, Cell Biology, University of Miami Miller School of Medicine

Stephen BeersPh.D., Associate Professor, Cancer Immunology and Immunotherapy, Univer-sity of Southampton, United Kingdom

John Bell Ph.D., Senior Scientist, Center for Innovative Cancer Research, Ottawa Hospital Research Institute

Michael BergmannM.D., Ph.D., CMO, Vacthera

Jay A. BerzofskyM.D., Ph.D., Chief, Vaccine Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health

Allison S. BetofM.D., Ph.D., Medical Oncol-ogy Fellow, Memorial Sloan Kettering Cancer Center

Sihem BihorelMS, Pharm.D., Ph.D., Assis-tant Professor, Department of Pharmaceutics, College of Pharmacy, University of Florida

Pamuk BilselPh.D., CSO, FluGen

Laurent BoisselPh.D., Associate Director, Research & Development, NantKwest, Inc.

Mark BonyhadiPh.D., Head, Research and Academic Affairs, Juno Therapeutics

Darrell R. BorgerPh.D., Director, Biomarker Laboratory, Massachusetts General Hospital Cancer Center

Marnix BoschPh.D., CTO, Northwest Biotherapeutics

Marcus BosenbergM.D., Ph.D., Associate Professor, Dermatology and Pathology, Yale School of Medicine; Co-Leader, Genomics, Genetics and Epigenetics Program, Yale Cancer Center

Adrian BotM.D., Ph.D., Vice President, Translational Research, Kite Pharma

Zachary BoydPh.D., Companion Diagnostic Program Leader - Tecentriq (Atezolizumab), Genentech

James BradyPh.D., Vice President, Techni-cal Applications & Customer Support, MaxCyte

Caroline BreitbachPh.D., Vice President, Translational Development, Turnstone Biologics

Joshua BrodyM.D., Director, Lymphoma Immunotherapy Program, Icahn School of Medicine at Mount Sinai

Wendy BroomPh.D., Associate Director, Innovation and Automation, Genocea Biosciences

Tullia BrunoPh.D., Research Assistant Professor, Immunology, University of Pittsburgh

Lisa H. ButterfieldPh.D., Professor, Medicine, Surgery and Immunology, University of Pittsburgh

Martina CanestraroPh.D., Senior Scientist, Preclinical Biology, Immunocore, Ltd.

Carmine CarpenitoPh.D., Principal Scientist, ImClone Systems, Eli Lilly & Co.

Edward ChaM.D., Ph.D., Associate Medical Director, Cancer Immunotherapy Franchise, Genentech

Brian R. ChampionPh.D., CSO, Psioxus Therapeutics Ltd.

Michelle Chan ArcherSenior Formulations Special-ist, Infectious Disease Research Institute

Ken ChangPh.D., Vice President, Research and Development, Immunomedics

Yvonne Y. ChenPh.D., Assistant Professor, Chemical and Biomolecular Engineering, University of California Los Angeles

Zhao ChenPh.D., Investigator III, Exploratory Immuno-Oncology, Novartis Institute of Biomedical Research

Dennis ChristensenPh.D., Head of Vaccine Adjuvant Research Group, Center for Vaccine Research, Statens Serum Institute, Denmark

Raphael ClynesM.D., Ph.D., Vice President, Translational Biology, Xencor

Mark CobboldMRCP, Ph.D., Associate Professor, Massachusetts General Hospital Cancer Center

Jean-Marie CuillerotM.D., CMO, Agenus

Rony DahanPh.D., Principal Investigator, Immunology, Weizmann Institute of Science, Israel

Naveen DakappagariPh.D., Senior Director, Pro-tein and Immuno-Oncology Biomarker Development, Navigate Biopharma, a Novartis Company

Asha DasM.D., Vice President, Clinical Development and Medical Affairs, Tocagen Inc.

Jishnu DasPh.D., Postdoctoral As-sociate, Lauffenburger Lab, Biological Engineering, MIT & Alter Lab, Ragon Institute of MGH, MIT & Harvard

Adil DaudM.D., Professor, Hematol-ogy/Oncology, University of California, San Francisco; Director, Melanoma Clinical Research, UCSF Helen Diller Family Comprehensive Cancer Center

Naomi De SilvaClinical Site Educator, Clinical Research, Sillajen Biotherapeutics, Inc.

Tara L. DeansPh.D., Assistant Professor, Bioengineering, University of Utah

Lelia DelamarrePh.D., Group Leader, Cancer Immunotherapy Department, Genentech

Jerrod DenhamPh.D., Dark Horse Consulting

Boro DropulicPh.D., General Manager and CSO, Lentigen Technology, Inc.

Mark DudleyPh.D., Senior Vice President, Bioprocessing, Adaptim-mune

Jakob DupontM.D., MA, Vice President, Global Head Breast & Gyn Cancer Development, Genentech, A Member of the Roche Group

Olivier ElementoPh.D., Cancer Systems Biol-ogy and Precision Medicine, Weill Cornell Medicine

Justin EyquemPh.D., Research Fellow, Im-munology, Memorial Sloan Kettering Cancer Center

Wendy J. FantlPh.D., Assistant Professor, Obstetrics and Gynecology, Stanford University School of Medicine

Steven FlingPh.D., Staff Scientist, Vac-cine & Infectious Disease, Fred Hutchinson Cancer Research Center; Director, Cancer Immunotherapy Trials Network Immune Monitoring Laboratory

Maryland Franklin Ph.D., Vice President, Scientific Development, MI Bioresearch

Agnete FredriksenPh.D., CSO, Vaccibody

Morganna FreemazDO, FACP, Associate Director, Melanoma & Cutaneous Oncology Program, The Angeles Clinic and Research Institute

Masha Fridkis-Hareli M.Sc., Ph.D., Founder and President, ATR, LLC

Matthew FrigaultM.D., Post-Doctoral Fellow, Cellular Immunotherapy, Dana-Farber Cancer Institute

Justin F. GainorM.D., Instructor in Medicine, Massachusetts General Hospital

Robert GarryPh.D., Professor & Director, Microbiology and Immunology, Tulane University School of Medicine

Arnold GelbM.D., Senior Director, Companion Diagnostic Development, EMD Serono, Inc.

Laura Hix GlickmanPh.D., Senior Scientist, Aduro Biotech

Paul GonzalesVice President, Non-Clinical Operations, TD2

Paola GrandiPh.D., Senior Research Director, Immunology/Virology, Oncorus, Inc.

Farshad GuirakhooPh.D., CSO, GeoVax, Inc.

Ruchi GuptaPh.D., Team Lead Scientist, MedImmune

Yuriy GusevPh.D., Associate Professor, Innovations Center for Biomedical Informatics (ICBI), Georgetown University Medical Center

Dario GutierrezPh.D., Immuno-Biology Lead, Merck Research Labs

Abdel HalimPh.D., Vice President, Translational Medicine, Biomarkers & Diagnostics, Celldex Therapeutics

Sam HanashM.D., Ph.D., McCombs Institute for Cancer Early Detection and Treatment, MD Anderson Cancer Center

Aaron HansenM.D., Ph.D., Assistant Professor, Department of Medicine, University of Toronto; Medical Oncologist, Princess Margaret Cancer Center

Ryan HeiserPh.D., Senior Scientist, Immunology, Seattle Genetics

Rikke HolmgaardPh.D., Senior Research Scientist, Eli Lilly

Shuguang HuangPh.D., CSO, Stat4ward LLC

David HussPh.D., Senior Scientist, CAR T Cell Team Lead, Juno Therapeutics

Ella IoffePh.D., Associate Director, Immune-Oncology, Regeneron Pharmaceuticals

Farren IsaacsPh.D., Assistant Professor, Molecular Cellular & Developmental Biology, Systems Biology Institute, Yale University

Vidyashankara IyerPh.D., Scientist, Formulation Sciences, MedImmune

Xiaomo JiangPh.D., Investigator, Immuno-Oncology, Novartis Institutes for BioMedical Research

Karin JoossCSO, Gritstone Oncology

Pawel KalinskiM.D., Ph.D., Professor, Oncol-ogy, Vice-Chair, Translational Research, Roswell Park Cancer Institute

Megan M. KanedaPh.D., Assistant Project Scientist, University of California, San Diego

David KaufmanM.D., Ph.D., Executive Director, Translational Im-munology & Oncology, Merck Research Laboratories

Howard L. KaufmanM.D., FACS, Surgical Oncologist, Rutgers Cancer Institute of New Jersey

Tibor KelerPh.D., Senior Vice President & CSO, Celldex Therapeutics

Llew KeltnerM.D., Ph.D., CEO, EPISTAT

Sanjay Khare

Ph.D., President, ImmunGene

Takashi K. KishimotoPh.D., CSO, Selecta Biosciences

Harry KleanthousPh.D., Associate Vice President, Head, Research (North America), Sanofi Pasteur

Emilee KnowltonPh.D., Immunology Sales Specialist, ProImmune

Keith KnutsonPh.D., Director, Cancer Vaccine & Immune Therapies Program, Mayo Clinic

Art KriegM.D., Founder, President and CEO, Checkmate Pharmaceuticals

Lakshmi KrishnanPh.D., Director & Program Leader, Vaccines and Im-munotherapeutics, National Research Council, Canada

Klaus KühlckeManaging Director, EUFETS GmbH

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Lawrence S. Lamb, Jr.M.N., Ph.D., Professor, Medicine; Director, Cell Therapy Laboratory, University of Alabama at Birmingham

Gary LeePh.D., Director, Genome Edit-ing, Sangamo Therapeutics

Daniel L. LeveyPh.D., Senior Director, Vaccine Research, Agenus

Bruce LevinePh.D., Barbara and Edward Netter Professor, Cancer Gene Therapy, University of Pennsylvania Perelman School of Medicine

Daniel LingwoodPh.D., Assistant Professor, Medicine, Harvard Medical School

Andrey LobodaPh.D., Director, Genetics and Pharmacogenomics, Merck

Shan Lu M.D., Ph.D., Professor, Medicine, University of Massachusetts Medical School

Jason J. LukeM.D., FACP, As-sistant Professor of Medicine, Melanoma and Developmental Therapeutics Clinics, University of Chicago Medical Center

Ravi MadanM.D., Clinical Director, Genitourinary Malignancies Branch, National Cancer Institute

Stefano MajocchiPh.D., Research Scientist, Novimmune SA

Marc MansourPh.D., Chief Business Officer, Vaximm AG

Alex MarsonM.D., Ph.D., Assistant Professor, Microbiology and Immunology, Divisions of Infectious Diseases and Rheumatology, Department of Medicine, UCSF Diabetes Center, University of California San Francisco

Emma Masteller

Ph.D., Senior Director, Immuno-Oncology R&D, Inovio Pharmaceuticals

Douglas G. McNeelM.D., Ph.D., Professor of Medicine & Director, Solid Tu-mor Immunology Research, University of Wisconsin Carbone Cancer Center

Laurence MenardPh.D., Senior Research Investigator, Bristol-Myers Squibb

Leonid S. MetelitsaM.D., Ph.D., Professor, Pediatrics and Immunology, Texas Children’s Cancer Center, Center for Cell & Gene Therapy, Baylor College of Medicine

Jan ter MeulenM.D., CSO, Immune Design

Paula Miliani de MarvalPh.D., Research Associate Director, Charles River Laboratories Discovery Services

Yueh-Ming LooPh.D., Research Assistant Professor, Immunology, University of Washington

Shigeki Miyake-StonerPh.D., Translational Specialist, Molecular and Cell Biology Laboratories, Salk Institute for Biological Studies

Ali MohamedPh.D., Vice President, CMC, Immatics US, Inc.

Richard MorganPh.D., Vice President, Immunotherapy, Bluebird Bio

Zachary S. MorrisM.D., Ph.D., Assistant Professor, Human Oncology, University of Wisconsin School of Medicine and Public Health

Matthew MulveyPh.D., CEO, BeneVir Biopharm, Inc.

Hiroshi NakashimaPh.D., Instructor, Neurosci-ence, Brigham and Women’s Hospital

Jaclyn NeelyPh.D., Senior Research Investigator II, Translational Medicine, IO Biomarker Lead, Bristol-Myers Squibb

Brad NelsonPh.D., Co-Director, Immunotherapy Program, British Columbia Cancer Agency, Canada

Fares NigimM.D., Massachusetts General Hospital and Harvard Medical School

Jianfang NingPh.D., Instructor, Neurosurgery, Massachusetts General Hospital, Harvard Medical School

Tatiana NovobrantsevaPh.D., Co-Founder, Head of Research and Development, Verseau Therapeutics

Alison O’MahonyPh.D., Vice President, Research Biology, DiscoverX Corporation

Clodagh O’SheaPh.D., Howard Hughes Medi-cal Institute Faculty Scholar; Associate Professor, William Scandling Developmental Chair, Molecular and Cell Biology Laboratory, Salk Institute for Biological Studies

Christopher L. O’Sullivan Associate Scientist, Biologics and Target Biology, Gilead Sciences

Shane Olwill Ph.D., Vice President, Head of Development & Immuno-Oncology, Pieris Pharmaceuticals GmbH

Joost OppenheimM.D., Senior Investigator, Cancer and Inflammation Program, Head, Cellular Immunology Sec-tion, National Cancer Institute, National Institutes of Health

Willem W. OverwijkPh.D., Professor, Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center

Saumya PantPh.D., Associate Research Director, The Biocon Bristol-Myers Squibb Research & Development Center (BBRC), Bangalore, India

Mark ParisPh.D., Associate Director, Translational Applications, Mitra Biotech

Angie Inkyung ParkPh.D., Senior Director, Immunotherapy and Stem Cells, OncoMed Pharmaceuticals Vasiliki PelekanouM.D., Ph.D., Associate Research Scientist, Pathol-ogy, Yale University School of Medicine

Sari PesonenVice President, Clinical Development, Valo Therapeutics

Nikolai PetrovskyMBBS, Ph.D., Chairman & Research Director, Vaxine; Professor, Flinders University

Gayatri Premasekharan Ph.D., Postdoctoral Scholar, Urology, University of California, San Francisco

Graeme E. PricePh.D., Research Microbiologist, Gene Transfer & Immunogenicity, FDA CBER

Peter PushkoPh.D., President & CSO, Medigen

Anna Marie PylePh.D., William Edward Gilbert Professor, Molecular, Cellular & Developmental Biology, Yale University

Yan QuPh.D., Senior Principal Scientist, Pfizer

Samuel D. RabkinPh.D., Professor, Neurosurgery, Massachu-setts General Hospital and Harvard Medical School

Rama Rao AmaraPh.D., Professor, Microbiol-ogy and Immunology, Emory University

David A. ReardonM.D., Professor, Medicine, HarvardMedical School; Clinical Director, Center for Neuro-Oncology, Dana-Farber Cancer Institute

Paul RennertPh.D., President and CSO, Aleta Biotherapeutics Inc.

Alexandre ReubenPh.D., Postdoctoral Fellow, Surgical Oncology, The University of Texas MD Anderson Cancer Center

Kole T. RoybalPh.D., Assistant Professor, Microbiology, Immunology, University of California San Francisco

Christophe SachsePh.D., Site Head Berlin, NMI TT Pharmaservices

Kurt SchalperM.D., Ph.D., Assistant Professor, Pathology and Medicine (Medical Oncology), Yale School of Medicine

Dolores J. SchendelPh.D., CEO & CSO, Medigene AG

Jonathan D. SchoenfeldM.D., MPhil, MPH, Assistant Professor, Radiation Oncol-ogy, Harvard Medical School

Fiona SharpPh.D., Investigator II, Exploratory Immuno-Oncology, Novartis Institutes for BioMedical Research

Alexander ShneiderPh.D., CEO/CSO, CureLab

John K. SimmonsPh.D., Director, Translational Science & Diagnos-tics, Personal Genome Diagnostics, Inc.

Manmohan Singh

Ph.D., Senior Director, Vaccine Formulation Development, Takeda Phar-maceuticals

Anna SlagerProduct Development Scientist, Inovio

Julianne SmithPh.D., Vice President, Translational Science, Cellectis

Ryan T. SowellPh.D., Postdoctoral Fellow, Immunobiology, Yale University School of Medicine

Elena SpanjaardPh.D., Director, Worldwide Research & Development, Regulatory Affairs, Pfizer

David M. SpencerPh.D., CSO, Research & Development, Bellicum Therapeutics

Stefani SprangerPh.D., Assistant Professor, Biology, MIT

Sasha StantonM.D., Ph.D., Acting Instructor, Breast Oncology, University of Washington Tumor Vac-cine Group

Zhen SuM.D., MBA, Vice President & Head of Global Medical Affairs – Oncology, EMD Serono

Gokul SwaminathanPh.D., Immuno-Biology Group, Merck Exploratory Science Center, Merck & Co., Inc.

Steven J. SwansonPh.D., Senior Vice President, Research, ImmunoCellular Therapeutics, Ltd.

Janis TaubeM.D., Associate Professor, Dermatology & Pathology, Johns Hopkins University

Steve H. ThorneCSO, Western Oncolytics Ltd.

Mark ThrosbyPh.D., EVP & CSO, Merus N.V., The Netherlands

Talar TokatlianPh.D., Postdoctoral Research Associate, Irvine Lab, Massachusetts Institute of Technology

Simon van HarenPh.D., Research Fellow, Divi-sion of Infectious Diseases, Boston Children’s Hospital

Derek A. Wainwright

Ph.D., Assistant Professor, Departments of Neurological Surgery, Microbiology-Immunology, and Division of Hematology-Oncology, Northwestern University Feinberg School of Medicine

Nicola WallisPh.D., Senior Director, Biology, Astex Therapeutics, Ltd., United Kingdom

Mike WatsonPresident, Valera, A Moderna Venture

William WattPh.D., President & CEO, EpiThany

Glen J. WeissM.D., MBA, Clinical Associ-ate Professor, University of Arizona College of Medicine, Phoenix

Ron WeissPh.D., Professor, Biological Engineering, Synthetic Biol-ogy Center, Massachusetts Institute of Technology

Theresa WhitesidePh.D., Professor, Pathology, Immunology & Otolaryngol-ogy, University of Pittsburgh School of Medicine

Chan C. WhitingPh.D., Director, Immune Monitoring and Biomarker Development, Aduro Biotech

Jon WiggintonM.D., CMO, Senior Vice-President, Clinical Development, MacroGenics

Ignacio I. WistubaM.D., Department Chair, Department of Transla-tional Molecular Pathology, Division of Pathology & Lab Medicine, The University of Texas MD Anderson Cancer Center

K. Dane WittrupPh.D., Carbon P. Dubbs Professor, Chemical Engineering and Biological Engineering, Massachusetts Institute of Technology

Rich WoessnerPh.D., Principal Scientist, IMED Oncology, AstraZeneca Pharmaceuticals

Wilson WongPh.D., Assistant Professor, Biomedical Engineering, Boston University

Jennifer WuPh.D., Professor, Feinberg School of Medicine; Director, Cancer Immunology Program, Robert Lurie Comprehensive Cancer Center, Northwestern University

Masahide YanoPh.D., Research Scientist, Center for Drug Evaluation and Research, FDA

Hao YinPh.D., Research Scientist, The David H. Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology

Xingxing ZangPh.D., Associate Professor, Microbiology and Immunology & Medicine, Albert Einstein College of Medicine

Litao ZhangPh.D., Vice President, Leads Discovery and Optimization, Bristol-Myers Squibb

Theresa ZhangPh.D., Vice President, Per-sonalized Cancer Vaccines, Genocea Biosciences

Gergana ZlatevaPh.D., Vice President, Payer Insights and Access, Oncology, Pfizer

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Plenary Keynotes TUESDAY | AUGUST 29

4:00 Regulatory and Scientific Considerations for Cancer Vaccines and Adoptive Cellular ImmunotherapyGraeme E. Price, Ph.D., Research Microbiologist, Gene Transfer & Immunogenicity, FDA CBER

4:45 Market Access and Reimbursement for Immuno-Oncology Drugs in Today’s Healthcare SystemGergana Zlateva, Ph.D., Vice President, Payer Insights and Access, Oncology, Pfizer

Emerging Investigator

NEW THIS YEAR: Emerging InvestigatorsA select number of presentations were chosen from rising stars in the field of immuno-oncology. The goal of this initiative is to not only showcase the future of the field, but also to provide our delegates with cutting-edge research that they won’t see elsewhere. These presentations are noted with the icon you see here. Emerging

Investigator

Look for this icon within the agenda for talks featuring emerging investigators



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MEDIA PARTNERS

Tuesday & Thursday Dinner Short Courses

TUESDAY, AUGUST 29

Dinner Short Courses 6:30 - 9:00 pm

Short Course 1: Bioinformatics for Immuno-Oncology and Translational ResearchInstructor:Yuriy Gusev, Ph.D., Associate Professor, Innovations Center for Biomedical Informatics (ICBI), Georgetown University Medical Center

Short Course 2: Microbiome in Immuno-Oncology Instructors:Dario Gutierrez, Ph.D., Immuno-Biology Lead, Merck Research LabsLata Jayaraman, Ph.D., Head, Tumor Immunotherapy, Seres Therapeutics

THURSDAY, AUGUST 31

Dinner Short Course 6:30 - 9:00 pm

Short Course 4: CRISPR/Cas9 Applications in ImmunotherapyInstructor: Kathrin Schumann, Ph.D., Fellow, Marson Lab, University of Californa San FranciscoHao Yin, Ph.D., Research Scientist, The David H. Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology



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Development

Immunomodulatory Therapeutic Antibodies for Cancer

Rational Combination Cancer Immunotherapy







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Immunomodulatory Therapeutic Antibodies for CancerScientific Strategies for Discovering and Developing Novel Immunotherapies and Agents to Improve the Efficacy and Toxicology Profiles of T Cell-Targeted Biotherapeutics

MON-TUE | AUGUST 28-29

MONDAY, AUGUST 28

7:30 am Registration & Morning Coffee

8:25 Chairperson’s Opening RemarksYan Qu, Ph.D., Senior Principal Scientist, Pfizer

8:30 KEYNOTE PRESENTATION: Enabling Effective Immuno-OncologyGregory Adams, Ph.D., CSO, Eleven BiotherapeuticsCheckpoint inhibitors and other immune-oncology agents have shown significant promise in the treatment of a variety of cancers. However, many of these agents are only effective when an existing host immune response has already been induced by other therapeutic approaches. I will discuss strategies that may be used to effectively set the stage for immune-oncology treatments including Eleven BioTherapeutics’ Targeted Protein Therapeutics.


9:00 Immunomodulatory Antibodies – Potentiation by Fc Receptor EngagementRony Dahan, Ph.D., Principal Investigator, Immunology, Weizmann Institute of Science, IsraelImmunomodulatory mAbs are revolutionizing cancer treatment due to their clinical effective stimulation of therapeutic anti-cancer immunity. Recent studies demonstrated the importance of the Fc domain of these types of mAbs. Their optimal activity can be critically depended on their ability to engage defined FcgR pathways. I will discuss our recent characterization of these FcgR-dependent mechanisms, and how they can be exploited for introducing second generation Fc-optimized immunomodulatory mAbs.

Sponsored by9:30 Coffee Break

MECHANISMS OF ACTION


10:00 The Role of Metabolism in Immune Response in Tumors: Merging the Past and the Present of Tumor Microenvironment

Allison S. Betof, M.D., Ph.D., Medical Oncology Fellow, Memorial Sloan Kettering Cancer CenterTumors are not simply collections of cancer cells that arise in a vacuum; they are instead complex structures composed of blood vessels, immune cells, and other supporting structures that interact, consume oxygen and other nutrients, and produce waste. Tumor metabolism has long been viewed as a therapeutic target. I will discuss recent data on how metabolism influences immunobiology and our group’s approach to harness these interactions to improve therapeutic outcomes.


10:30 PI3Kgamma Is a Molecular Switch that Controls Immune SuppressionMegan M. Kaneda, Ph.D., Assistant Project Scientist, University of California, San DiegoMacrophages play critical but opposite roles in inflammation and cancer. We have found that the predominant isoform of PI3K in myeloid cells, PI3Kgamma, controls the switch between immune stimulation and immune suppression. Inhibition of macrophage PI3Kgamma activity promotes an immunostimulatory transcriptional program that restores CD8+ T cell activation and cytotoxicity and synergizes with checkpoint inhibitor therapy to promote tumor regression and extend survival in mouse models of cancer.

11:00 Avelumab (hIgG1 Anti-human PD-L1) Mediates the Anti-Tumor Efficacy via Multiple Pathways in Preclinical ModelsYan Qu, Ph.D., Senior Principal Scientist, PfizerAnalysis of PD-L1 expression on various immune subpopulations in human patient samples showed that PD-L1 is enriched on non-T cells. In tumor-bearing mice, the percentage of splenic NK cells was increased with WT avelumab treatment but not with the Fc isotype variant. Avelumab-induced tumor shrinkage, tumor-infiltrating CD8+ T cell increase, and tumor PD-L1+ immature myeloid cell decrease appear to require NK cells, as such changes were abolished upon NK depletion.

Sponsored by11:30 Epitope Identification and Clinical Immune Monitoring in Immune Oncology Programs Emilee Knowlton, Ph.D., Immunology Sales Specialist, ProImmune

12:00 pm Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

12:30 Session Break

TARGET DISCOVERY FOR NEXT GENERATION IMMUNOTHERAPIES

1:25 Chairperson’s RemarksStephen Beers, Ph.D., Associate Professor, Cancer Immunology and Immunotherapy, University of Southampton, United Kingdom

1:30 Functional Characterization of Macaque Fcr and IgG SubtypesMargie Ackerman, Ph.D., Assistant Professor, Engineering, Dartmouth CollegeA number of antibody therapies rely on Fc receptor (FcR)-mediated effector functions for optimal activity, prompting the need to understand how native and IgG domains engineered to differentially bind to the human receptors translate in non-human primate (NHP) models. We report characterization of the affinity between an IgG Fc variant panel (including subclass, Fc mutants and glycosylation) and major human and rhesus FcR allotypic variants.

2:00 Utilizing Patient-Derived Organoids and High-Content Imaging for Screening and Characterization of Bispecific AntibodiesMark Throsby, Ph.D., EVP & CSO, Merus N.V., The Netherlands This presentation will provide a case study on how panels of patient-derived organoids grown ex-vivo in 3D culture combined with high-content imaging can be applied to bispecific antibody screening. Lead candidate bispecifics were selected targeting the wnt pathway with novel modes of action including immunomodulation.



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Immunomodulatory Therapeutic Antibodies for Cancer MON-TUE | AUGUST 28-29

2:30 Discovery and Development Strategies for New Small Molecule ImmunotherapiesNicola Wallis, Ph.D., Senior Director, Biology, Astex Therapeutics, Ltd.Small molecules are of interest as immunotherapies as both single agent and combinations, offering the possibility of modulating different aspects of the immune system to biologics. We are exploring targeting a number of different immunomodulatory mechanisms with small molecules derived using fragment-based drug design and will describe examples in this presentation.

Sponsored by

3:00 Refreshment Break

IMMUNE SYSTEM PRIMING AND ACTIVATION

3:30 STING Adjuvants for Immune System Priming for Antibody TherapyStephen Beers, Ph.D., Associate Professor, Cancer Immunology and Immunotherapy, University of Southampton, United KingdomSuccessful tumor-targeting antibody approaches appear to rely predominantly on the effector function of Fcγ receptor (FcγR) expressing macrophages. Unfortunately, tumor-associated macrophages (TAM) are frequently poorly cytotoxic, contribute to immune suppression and have suboptimal FcγR expression making treatment less effective. Here we show that STING agonists are able to overcome immunosuppression in the tumour microenvironment effectively reversing the TAM inhibitory FcγR profile and provided strong adjuvant effects to antibody therapy.

4:00 Next-Generation Cancer VaccinesDaniel L. Levey, Ph.D., Senior Director, Vaccine Research, AgenusAgenus is advancing two fully synthetic cancer vaccine platforms. The first is based on identification of mutations encoded in the tumor genome while the second relates to a novel class of tumor specific neo-epitopes arising from inappropriate phosphorylation of various proteins in malignant cells. The platforms support the manufacture of both individualized and off-the-shelf cancer vaccines against a range of tumor antigens, increasing the likelihood of immune recognition of tumors.

4:30 Oral T Cell Vaccines Targeting Immune Organs of the Gut for Generating Systemic Antigen Specific T CellsMarc Mansour, Ph.D., Chief Business Officer, Vaximm AGWe use attenuated Salmonella typhi Ty21 as a vector

to deliver a plasmid encoding antigens of interest via the oral route to Peyer’s patches. The bacteria have built in adjuvant properties and induce cross presentation to produce a systemic T cell response. Monotherapy with a candidate targeting VEGFR2 produced clinical responses in GBM, highlighting the unique properties of this T cell vaccine approach.

5:00 End of Day

TUESDAY, AUGUST 29

7:25 am Breakout Discussion Groups with Continental Breakfast

NON-RESPONDERS, SIDE EFFECTS AND TOXICOLOGY

8:25 Chairperson’s Opening RemarksAdam J. Adler, Ph.D., Professor, Immunology, University of Connecticut

8:30 Cancer Immunotherapy with Live-attenuated, Double Deleted Listeria Monocytogenes (LADD) Combination Strategies for the Treatment of Malignant Pleural MesotheliomaChan C. Whiting, Ph.D., Director, Immune Monitoring and Biomarker Development, Aduro BiotechWe are advancing CRS-207, a clinical LADD strain engineered to express mesothelin, in combinations with various modalities for the treatment of malignant pleural mesothelioma. Data from a Phase 1b study combining CRS-207 with standard chemotherapy demonstrating encouraging clinical and immune responses will be discussed. An overview of the Phase 2 study design and progress of the CRS-207/Pembrolizumab combination study will also be highlighted.

9:00 Tumor and Class-Specific Patterns of Immune-Related Adverse Events of Immune Checkpoint Inhibitors: A Systematic ReviewAaron Hansen, M.D., Ph.D., Assistant Professor, Department of Medicine, University of Toronto; Medical Oncologist, Princess Margaret Cancer Center Through a systematic review, we identified distinct immune related adverse event (irAE) profiles based on tumor type and immune checkpoint inhibitor class (CTLA-4 and PD-1). CTLA-4 inhibitors have a higher frequency of grade 3/4 irAEs. Furthermore, for patients treated with PD-1 inhibitors, those with melanoma had a higher frequency of gastrointestinal and skin irAEs, and lower rate of pneumonitis compared with patients with NSCLC and RCC.

Different immune microenvironments may drive histology-specific irAE patterns.

PROTEIN ENGINEERING

9:30 Combination Therapy with PD-1 Blockade Enhances the Antitumor Potency of T Cells Redirected by Novel Bispecific AntibodiesKen Chang, Ph.D., Vice President, Research and Development, ImmunomedicsNovel bispecific antibodies that bind bivalently to tumor antigens and monovalently to CD3 can redirect T cells to kill Trop-2- or CEACAM5-expressing solid cancer cells grown in monolayer cultures at low picomolar concentrations. The antitumor efficacy was demonstrated also in a humanized mouse model and in 3D spheroids generated with cells from TNBC and colonic cancers. Combining anti-PD-1 increased cell death in 3D spheroids and prolonged survival of tumor-bearing animals.

Sponsored by10:00 Accelerated Production of Immunomodulatory Therapeutic Antibodies & Bispecific Molecules Using Scalable Cell EngineeringJames Brady, Ph.D., Vice President, Technical Applications & Customer Support, MaxCyteAntibodies and antibody-like molecules are a proven means of modulating effective anti-tumor immune responses. MaxCyte’s delivery platform facilitates rapid, fully scalable, high quality transient protein production in the cell line-of-choice, as well as streamlined stable pool and cell line generation enabling accelerated development of relevant immunomodulatory candidates. Case studies will illustrate the identification and development of antibodies, tribodies & bi-specific T cell engaging molecules (BiTEs) using the MaxCyte platform.

10:30 Grand Opening Coffee Break in the Exhibit Hall with Poster Viewing

11:15 A Novel, Dual-Specific Antibody Conjugate Targeting CD134 and CD137 Costimulates T Cells and Elicits Antitumor ImmunityAdam J. Adler, Ph.D., Professor, Immunology, University of ConnecticutCombining agonists to different costimulatory receptors can be more effective in controlling tumors compared to individual agonists, but presents logistical challenges and increases the potential for adverse events. We developed a novel immunotherapeutic agent by fusing agonists to CD134 and CD137 into a single biologic, OrthomAb, that potentiates cytokine



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Immunomodulatory Therapeutic Antibodies for Cancer MON-TUE | AUGUST 28-29

secretion from TCR-stimulated T cells more potently than non-conjugated CD134 + CD137 agonists in vitro, and reduces tumor growth in vivo.

11:45 Targeted Tissue Delivery Using Caveolae Technology Improves Drug EfficacyRuchi Gupta, Ph.D., Team Lead Scientist, MedImmune

12:15 pm Close of Immunomodulatory Therapeutic Antibodies for Cancer



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Rational Combination Cancer ImmunotherapyA Forward-Looking View at the Science and Strategies That Will Inform the Discovery and Development of Effective Immunotherapy Combinations

TUE-WED | AUGUST 29-30

TUESDAY, AUGUST 29

12:00 pm Registration

1:15 Chairperson’s Opening RemarksElena Spanjaard, Ph.D., Director, Worldwide Research & Development, Regulatory Affairs, Pfizer

1:20 KEYNOTE PRESENTATION: Combination Cancer Immunotherapy: Current State and Future OpportunitiesJon Wigginton, M.D., CMO, Senior Vice President, Clinical Development, MacroGenicsThis presentation considers the guiding principles in the clinical development of immune-oncology combinations, to include patient selection, dose and schedule selection and optimizing risk/benefit. I will also discuss future opportunities for the clinical development of immuno-oncology combinations and provide analysis of the unique role and key considerations for bispecific approaches for combination immunotherapy.

CLINICAL EVALUATION OF IMMUNOTHERAPY COMBINATIONS

1:50 Regulatory Perspectives on Early Clinical Development in a Combinatorial WorldElena Spanjaard, Ph.D., Director, Worldwide Research & Development, Regulatory Affairs, PfizerEfficient co-development of novel combination therapies presents complex regulatory challenges that require modality-specific approaches. Current regulatory guidelines provide a framework for early development of investigational agents that are intended for use in combination. Regulatory concepts that address preclinical and clinical development of immuno-oncology combinations will be reviewed, and key considerations will be highlighted for various treatment modalities.

2:20 Application of Patient-Derived Xenografts in Immuno-Oncology Pre-Clinical Discovery, Target Validation, and Clinical Trials Ryan T. Sowell, Ph.D., Postdoctoral Fellow, Immunobiology, Yale University School of Medicine

Immuno-oncology faces major challenges in expediting the path of discovery to the clinic. As the number of targets grow, so does a need to rapidly validate them and the nearly infinite potential combinations therof. We will discuss how emerging humanized mouse models and single cell analyses can aid the rational design of combination therapies, while also providing opportunities to gain deep insight into biology that drives patient responses to immunotherapy.

2:50 Featured Poster Presentation: Inhibition of MMP9 Yields Improved Effector T Cell Responses in a PD1-Axis Refractory ModelChristopher L. O’Sullivan, Associate Scientist, Biologics and Target Biology, Gilead SciencesWe developed a monoclonal antibody that inhibits murine MMP9 and assessed its mechanism of action in immunocompetent mice alone or in combination with a murine anti-PDL1 antibody. A model of Her2-driven breast cancer was utilized for both efficacy and pharmacodynamic studies involving RNA and T cell receptor sequencing, enzymatic analyses, and flow cytometry. Inhibition of MMP9 reduced tumor burden and promoted cytotoxic T cell infiltration in this PD1-axis refractory model.

3:20 Refreshment Break in the Exhibit Hall with Poster Viewing

4:00 PLENARY KEYNOTE SESSIONClick here for details.

5:30 Welcome Reception in the Exhibit Hall with Poster Viewing

5:30 Dinner Short Course Registration*SC1: Bioinformatics for Immuno-Oncology and Translational ResearchSC2: Microbiome in Immuno-Oncology

*Separate registration required, please click here for details.

WEDNESDAY, AUGUST 30

7:00 am Registration

7:25 Breakout Discussion Groups with Continental Breakfast

IMMUNOTHERAPY COMBINATION STRATEGIES

8:25 Chairperson’s RemarksArt Krieg, M.D., Founder, President and CEO, Checkmate Pharmaceuticals

8:30 Four-Ingredient Antibody Cocktail for Cancer ImmunotherapyK. Dane Wittrup, Ph.D., Carbon P. Dubbs Professor, Chemical Engineering and Biological Engineering, Massachusetts Institute of TechnologyWe have determined that the combination of an anti-tumor antibody (A), IL-2 (I), anti-PD-1 antibody (P), and a therapeutic vaccine (V) is a highly efficacious and well-tolerated immunotherapy against established syngeneic tumors in mice. The AIPV formalism can be extended to include other agents; we have explored the use of an integrin-targeted Fc fusion that may also provide some degree of the I and V components of an AIPV therapy.

9:00 ADC Strategies for Cancer ImmunotherapyRyan Heiser, Ph.D., Senior Scientist, Immunology, Seattle GeneticsADCs have shown favorable results in numerous clinical trials, improving the tolerability of potent, broadly acting cytotoxins. The same properties that make ADCs attractive as single agents also enable them to be preferred partners for combinations with immunotherapy. This talk will provide an overview of the preclinical and clinical results of these combinations.

9:30 Combination Therapy with Anti-PD-1 and CMP-001, A CpG-A Oligodeoxynucleotide in a Virus-Like Particle, Can Induce Tumor Regression in PD-1 Refractory Patients with Advanced MelanomaArt Krieg, M.D., Founder, President and CEO, Checkmate PharmaceuticalsAnti-PD-1 therapy can induce regression of tumors that are immunologically “hot”, but has generally been ineffective in treating tumors that are immunologically “cold”. We have now demonstrated that activation of tumor-infiltrating plasmacytoid DC (TI-pDC) through



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TUE-WED | AUGUST 29-30Rational Combination Cancer Immunotherapy

TLR9 by CMP-001 converts “cold” tumors to create a “hot” IFN-rich tumor microenvironment and, in combination with systemic anti-PD-12 therapy, induces local tumor regression and abscopal regression of visceral metastases in patients with PD-1 refractory advanced melanoma.

10:00 Featured Poster Presentation: Immune Checkpoint Inhibitors for the Treatment of Human Colon Carcinoma in the hPBMC-NCG Humanized Mouse ModelPaula Miliani de Marval, Ph.D., Research Associate Director, Charles River Laboratories Discovery ServicesThe availability of NSG, NCG and NOG superimmune-deficient mice have proven instrumental in the development of humanized mouse models. These models offer unique tools to assess the anti-tumor response to immune-checkpoint inhibitors in animals bearing a human immune environment. The work presented here shows that NCG mice successfully engraft with hPBMC providing a suitable model for pre-clinical immune-oncology studies. The results from these studies will be discussed in this presentation.

10:30 Coffee Break in the Exhibit Hall with Poster Viewing

11:15 Risk Assessment Strategies for Immunotherapy Combinations: Should My PD-1/PD-L1 Backbone Come from a Partner or via Internal Development?Llew Keltner, M.D., Ph.D., CEO, EPISTATVarious counts of anti-PD-1/PD-L1 unique compounds in development range from several dozen to over 200. Such proliferation of development efforts to a single target is unprecedented in pharma. Clinical and financial realities demand that almost any IO modality be tested clinically with modulators of PD-1/PD-L1. Development, clinical trial, IP, regulatory and marketing issues related to the internal/external access decision will be summarized, with the expectation of open challenge and discussion.

11:45 Customizing Cancer Immunotherapies to Match the Intrinsic Tumor MicroenvironmentBrad Nelson, Ph.D., Co-Director, Immunotherapy Program, British Columbia Cancer Agency, CanadaFocusing on gyneocological cancers, we apply genomic and molecular pathology approaches to define the mechanisms by which the immune system responds to the evolving tumor genome over space and time. We find that optimal anti-tumor immunity requires both T cells and antibody-producing B-lineage cells. We have identified three immune response patterns with distinct implications for immunotherapy.

These insights are being translated to clinical trials of adoptive T cell therapy.

12:15 pm Preclinical and Clinical Update: Immunotherapy Combination of Monoclonal Antibodies Fused to Immune Effector MoleculesSanjay Khare, Ph.D., President, ImmunGeneImmunGene is developing a novel class of biotherapeutics called Focused-Interferon therapy or FIT to activate anti-tumor response in the tumor microenvironment (TME). This approach empowers antibodies by genetically fusing them to tumor cell-killing cytokines that can also activate host immune system locally in the TME. This presentation details preclinical and clinical updates of FIT technology.

Sponsored by12:45 Luncheon Presentation: Prioritizing Combinations Using a Human Phenotypic Model for Drug DevelopmentMark Paris, Ph.D., Associate Director, Translational Applications, Mitra Biotech

1:15 Session Break

BIOMARKERS AND TREATMENT PROGRESSION FOR IMMUNOTHERAPY COMBINATIONS

1:55 Chairperson’s RemarksRavi Madan, M.D., Clinical Director, Genitourinary Malignancies Branch, National Cancer Institute

2:00 Combination Strategies to Overcome Resistance to Anti-PD-1/PD-L1 TherapiesOsama E. Rahma, M.D., Assistant Professor, Medicine, Center For Immuno-Oncology, Gastrointestinal Cancer Center, Dana-Farber Cancer InstituteDespite the encouraging response rate of variety of malignancies to anti-PD-1 and PD-L1 antibodies resistance do occur in most patients. Understanding the mechanism of resistance to anti-PD-1 and PD-L1 blockade remains challenging. We will explore hypotheses for this resistance and potential combinations that may overcome such resistance.

2:30 Rationale and Opportunities for Immunotherapy in the (Neo)Adjuvant SettingRavi Madan, M.D., Clinical Director, Genitourinary Malignancies Branch, National Cancer InstituteImmunotherapy has rapidly been developed as a metastatic treatment for several cancers, but its greatest potential may be as part of (neo)adjuvant strategies in patients with localized and curable disease. Immunotherapy strategies in (neo)adjuvant

prostate cancer will be discussed as a means to provide a template for similar studies in other cancers. Immune responses and imaging correlates will be discussed as possible biomarkers in such studies.

3:00 Emerging Immunotherapy Combinations in Non-Small Cell Lung CancerJustin F. Gainor, M.D., Instructor in Medicine, Massachusetts General HospitalImmune checkpoint inhibitors targeting the PD-1/PD-L1 axis are now standard therapies in non-small cell lung cancer (NSCLC). Despite the impact of these agents, however, only a minority of patients respond to therapy. To enhance the activity of PD-1/PD-L1 inhibitors in NSCLC, efforts are ongoing to develop rationale combination approaches. This presentation will describe emerging PD-1/PD-L1 inhibitor combination strategies in NSCLC, including chemotherapy, vaccines, targeted therapies, co-inhibitory and co-stimulatory agents.


BIOMARKERS AND COMPANION DIAGNOSTICS

4:15 Unique Biomarker Signatures Identified by Novel Quantitative Immunohistochemistry Algorithms Predict Response and Survival to PD-1 Blockers and ChemotherapyNaveen Dakappagari, Ph.D., Senior Director, Protein and Immuno-Oncology Biomarker Development, Navigate Biopharma, a Novartis CompanyAlthough PD-1/L1 axis-targeted therapies produce durable responses in a subset of patients, reliable tests predictive of anti-PD-1 responses have been elusive. This presentation will describe novel multiplexed immunohistochemistry algorithms quantifying two prominent mechanisms of immunosuppression and their clinical utility in metastatic melanoma patients (n > 150) treated with anti-PD1 and early stage lung cancer patients (n> 100) receiving adjuvant chemotherapy. Mechanistic and real world implications of these findings will be discussed.

4:45 Protein and Genomic Immune Biomarkers at the Chase of Maximal Sensitivity, Multiple Targets and Optimal ResponsesVasiliki Pelekanou, M.D., Ph.D., Associate Research Scientist, Pathology, Yale University School of MedicineImmunotherapy modern companion diagnostics are marked by the urging need for increased sensitivity for the detection of target biomarkers, the constellation of tumor and stromal cells participating in immunoediting, as well as their functional status. The double-edged interaction of tumor microenvironment



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TUE-WED | AUGUST 29-30Rational Combination Cancer Immunotherapy

with therapeutic regimens (conventional or immune-targeting) creates a dynamic continuum that needs close follow-up. The potential of protein vs. genomic approaches might not be equivalent in this era.

5:15 Co-Development Issues for Immunotherapy Companion DiagnosticsArnold Gelb, M.D., Senior Director, Companion Diagnostic Development, EMD Serono, Inc.Differences in regulatory pathways, development timelines and the progression of clinical studies create challenges when developing companion diagnostics for immunotherapies and associated combinations. This presentation will review these issues and outline possible strategies for successful co-development projects.

5:45 Close of Rational Combination Cancer Immunotherapy



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Emerging Techniques in Synthetic BiologyCustomizing Immune Cells for More Effective Immunotherapies

THU-FRI | AUGUST 31-SEPTEMBER 1

THURSDAY, AUGUST 31


NEW TECHNIQUES IN T CELL ENGINEERING

8:25 Chairperson’s Opening RemarksWilson Wong, Ph.D., Assistant Professor, Biomedical Engineering, Boston University

8:30 KEYNOTE PRESENTATION: Reining in T Cell Therapies in 2 Dimensions Should Promote Both Safety and EfficacyDavid M. Spencer, Ph.D., CSO, Research & Development, Bellicum TherapeuticsDespite great promise, adoptive cell therapies for solid tumors are still limited by efficacy and safety challenges. Using chemically induced dimerization (CID) that taps into fundamental properties of cell biology, we have developed orthogonal switches that permit regulation of T cell activity and persistence alongside survival control. Independent regulation of co-stimulation and apoptosis in the same cell is now possible using a scalable, clinically compatible process.

9:00 Synthetic Biology in Cellular ImmunotherapyWilson Wong, Ph.D., Assistant Professor, Biomedical Engineering, Boston UniversityThe transfer of tumor-targeting T cells to patients is a promising approach for cancer immunotherapy. Despite these encouraging results, many challenges remain to be addressed before T cell therapy can be widely adopted. Here I will describe our efforts in using synthetic biology to develop genetic circuits and switches for modulating T cell activation. These genetic tools will provide tools for managing the toxicity associated with T cell therapy.

9:30 Engineering Smarter and Stronger T Cells for Cancer ImmunotherapyYvonne Y. Chen, Ph.D., Assistant Professor, Chemical and Biomolecular Engineering, University of California Los AngelesSynthetic-biology principles can be applied to the engineering of therapeutic T cells to overcome challenges observed in the clinic. We will first discuss the rational

design and systematic optimization of bispecific, OR-gate CAR-T cells that robustly eliminate target cells expressing either CD19 or CD20, thereby reducing the risk of antigen escape in the treatment of B-cell malignancies. We will also present novel CARs that effectively rewire T cell responses to transforming growth factor beta (TGF-b), converting this potent immunosuppressive cytokine into a T cell stimulant and increasing the efficacy of adoptive T cell therapy against solid tumors.

10:00 Coffee Break in the Exhibit Hall (Last Chance for Poster Viewing)

10:45 PANEL DISCUSSION: Synthetic Biology Approaches to Immuno-OncologyModerator: Wilson Wong, Ph.D., Assistant Professor, Biomedical Engineering, Boston University• Gating strategies• Antigen presentation• Activation and kill switches for safer therapies• Innovative approaches to activation and engagementPanelists: Yvonne Y. Chen, Ph.D., Assistant Professor, Chemical and Biomolecular Engineering, University of California Los AngelesJustin Eyquem, Ph.D., Research Fellow, Immunology, Memorial Sloan Kettering Cancer CenterAlex Marson, M.D., Ph.D., Assistant Professor, Microbiology and Immunology, Divisions of Infectious Diseases and Rheumatology, Department of Medicine, UCSF Diabetes Center, University of California San Francisco

GENOME EDITING

11:45 Genome Modification and Evolution of CellsFarren Isaacs, Ph.D., Assistant Professor, Molecular Cellular & Developmental Biology, Systems Biology Institute, Yale University

12:15 pm Sponsored Presentation (Opportunity Available)

12:45 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:15 Session Break

GENOME EDITING (CONT.)

2:25 Chairperson’s RemarksDavid M. Spencer, Ph.D., CSO, Research & Development, Bellicum Therapeutics

2:30 Precision T Cell Engineering to Advance CAR TherapyJustin Eyquem, Ph.D., Research Fellow, Immunology, Memorial Sloan Kettering Cancer CenterTransducing T cells with synthetic chimeric antigen receptors (CARs) is a promising approach for treating certain types of cancer. We are developing innovative strategies to study CAR immunobiology and improve the performance and the safety of CAR T cells. We are using genome editing to target CAR genes to specific loci for precise expression control and augmented tumor killing activity.

3:00 Decoding T Cell Circuitry Alex Marson, M.D., Ph.D., Assistant Professor, Microbiology and Immunology, Divisions of Infectious Diseases and Rheumatology, Department of Medicine, UCSF Diabetes Center, University of California San Francisco Functional testing of human genome sequences in primary immune cells has been largely impossible until recently. We developed a CRISPR-Cas9 platform that enables knock-out and knock-in genome-editing in human T cells by electroporation of Cas9 ribonucleoproteins (Cas9 RNPs). Cas9 RNP technology holds great potential for therapeutic genome engineering. We aim to understand how sequence variation throughout the human genome affects T cell circuits in health and disease.


4:00 Highly Efficient, ZFN Driven, Derivation of Universal T CellsGary Lee, Ph.D., Director, Genome Editing, Sangamo TherapeuticsGenome (CCR5) edited T cells have been extensively evaluated in patients with HIV and were well tolerated. For applications in immune-oncology, we have developed ZFN reagents that can efficiently derive universal (TCR and HLA class I KO) T cells (>90% double KO without selection). In addition, >85%



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THU-FRI | AUGUST 31-SEPTEMBER 1Emerging Techniques in Synthetic Biology

targeted gene addition was achieved with locus specific donor molecules that encode various gene expression cassettes (e.g. GFP, CAR or TCR).

4:30 Featured Poster: Mapping the Genomic Landscape of CRISPR-Cas9 CleavagePeter Cameron, Ph.D., Senior Research Scientist, Caribou BiosciencesCRISPR-Cas9 RNA-guided endonucleases are widely used in genome engineering applications. Despite the development of methods to monitor nuclease specificity, there remains a lack of information on the possible off-target sequences that can be cleaved by Cas9, and under what conditions these sites accumulate mutations in cells. To address this, we developed a biochemical method based on the selective enrichment and identification of adapter-tagged DNA ends by sequencing (SITE-Seq). SITE-Seq enables us to generate a comprehensive list of Cas9 cut sites within genomic DNA, then separately examine those sites for off-target mutation in cells. Out results underscore the utility of using an unbiased biochemical approach to map the full spectrum of off-target sites, followed by direct analyses in cells.

5:00 PANEL DISCUSSION Beyond Immuno-Oncology: Where is Synthetic Biology Headed?Moderator: Mark Cobbold, MRCP, Ph.D., Associate Professor, Massachusetts General Hospital Cancer Center • Synthetic biology vs. other engineering fields • Computational and experimental approaches to engineering cell behavior • Additional indications for synthetic biology applicationPanelists: Tara L. Deans, Ph.D., Assistant Professor, Bioengineering, University of Utah Kole T. Roybal, Ph.D., Assistant Professor, Microbiology, Immunology, University of California San Francisco Ron Weiss, Ph.D., Professor, Biological Engineering, Synthetic Biology Center, Massachusetts Institute of Technology Shigeki Miyake-Stoner, Ph.D., Translational Specialist, Molecular and Cell Biology Laboratories, Salk Institute for Biological Studies

5:30 End of Day

6:00 Dinner Short Course Registration*

SC4: CRISPR/Cas9 Applications in Immunotherapy*Separate registration required, please click here for details

FRIDAY, SEPTEMBER 1

8:00 am Registration and Morning Coffee

ENABLING TECHNOLOGIES FOR FUTURE DIRECTIONS

8:25 Chairperson’s Opening RemarksTara L. Deans, Ph.D., Assistant Professor, Bioengineering, University of Utah

8:30 Phospho Neoantigens: Approaches to Neoantigen PredictionMark Cobbold, MRCP, Ph.D., Associate Professor, Massachusetts General Hospital Cancer Center


9:00 Hacking Immune Cells with Synthetic Notch Receptors to Expand Their Therapeutic PotentialKole T. Roybal, Ph.D., Assistant Professor, Microbiology, Immunology, University of California San FranciscoImmune cell therapies for cancer could benefit from more sophisticated engineering that 1) allows the cells to better discriminate diseased tissue from normal tissue and 2) expands their capabilities to overcome inhospitable tumor microenvironments. Synthetic Notch receptors are a versatile platform to address these problems allowing for customization of the therapeutic response programs of immune cells and the enhancement of their ability to discriminate diseased from healthy tissue.

9:30 Mammalian Synthetic Biology: From Parts to Modules to Therapeutic SystemsRon Weiss, Ph.D., Professor, Biological Engineering, Synthetic Biology Center, Massachusetts Institute of TechnologyRecent advances in synthetic biology are allowing us to expand beyond the construction and analysis of small gene networks towards the implementation of complex multicellular systems with a variety of applications. In this talk I will describe our integrated computational/experimental approach to engineering complex behavior in a variety of cells, with a focus on mammalian cells. In our research, we appropriate design principles from electrical engineering and other established fields. These principles include abstraction, standardization, modularity, and computer aided design.

10:00 Coffee Break


10:30 Synthetic Biology Approaches for Engineering Platelets as Delivery Systems for Treating DiseaseTara L. Deans, Ph.D., Assistant Professor, Bioengineering, University of UtahWe are currently using approaches in synthetic biology to direct hematopoietic stem cell differentiation to mass-produce platelets and red blood cells in vitro, in addition to enabling them to function as targeting and carrier devices for the delivery of biomolecules to areas of the body requiring intervention. I will demonstrate how tools in synthetic biology can be used to control genes and pathways that result in changes in stem cell fate decisions, in addition to reprogramming platelets to function as novel therapeutic diagnostic and delivery vehicles.

11:00 A Modular Approach to Engineering a Tumor-Specific Oncolytic Adenovirus with Small Molecule-Controlled Expanded TropismShigeki Miyake-Stoner, Ph.D., Translational Specialist, Molecular and Cell Biology Laboratories, Salk Institute for Biological StudiesThere are diverse and promising applications for viral vectors as vaccines, gene therapies, and oncolytic therapies, but they can only be realized if we can precisely engineer modifications to viruses to give them new desired properties. We have designed a strategy for assembling adenovirus genomes from a growing library of modules that are easy to genetically manipulate. Using our platform, we have designed an oncolytic adenovirus with selective tumor replication without the loss of replication potency, and that can be pharmacologically induced to infect cells via an additional receptor on refractory metastatic tumors in vivo.

11:30 Close of Emerging Techniques in Synthetic Biology



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TsImmunology for Drug Discovery Scientists


Emerging Immuno-Oncology Targets




Translational IO



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Tatiana Novobrantseva, Ph.D., Co-Founder, Head of Research and Development, Verseau Therapeutics

Dr. Tatiana Novobrantseva is a co-founder and the Head of Research and Development in the new immunology focused company Verseau Therapeutics. Prior to co-founding Verseau, she consulted for multiple companies on various immunological aspects of drug development across different stages and therapeutic modalities. At her prior position as Director of Tumor Immunology at Jounce Therapeutics, Tatiana defined research plans for several programs at the company’s inception, as well as led portfolio of programs on (re)activating immune system against cancer. Her previous positions include Associate Director at Alnylam Pharmaceuticals and Scientist II at Biogen. Some of Tatiana’s scientific accomplishments include discovering the critical role for B cells in liver fibrosis, pushing the envelope on siRNA delivery to immune cells and championing a siRNA-assisted dendritic cell cancer vaccine project. Tatiana is an inventor on more than 22 patents and an author on more than 36 peer-reviewed manuscripts. Tatiana completed her Ph.D. with Dr. Klaus Rajewsky in Cologne, Germany, focusing on B cell development and function.

Immunology for Drug Discovery ScientistsTsMON-TUE | AUGUST 28-29

Monday, August 28, 8:30 am – 5:00 pm | Tuesday, August 29, 8:30 am – 12:00 pm

TRAINING SEMINAR: IMMUNOLOGY FOR DRUG DISCOVERY SCIENTISTSInstructors:Masha Fridkis-Hareli, M.Sc., Ph.D., Founder and President, ATR, LLCTatiana Novobrantseva, Ph.D., Co-Founder, Head of Research and Development, Verseau Therapeutics

This 1.5-day seminar will cover the fundamentals of human immunology for an audience of biologists working in pharmaceutical and biotech organizations in programs related to cancer therapeutics. The class will offer perspectives on how immune responses can be monitored by assessment of biomarkers and modulated through biopharmaceutical intervention. Additionally, the course will cover a historical perspective, basic mechanisms and approaches to developing therapeutics and their combinations in immuno-oncology. Through group activities, attendees will design functional immunological assays and read-outs.

TOPICS INCLUDE:• Introduction to the immune system• Innate immunity• Adaptive immunity• Infections, inflammation, and cancer• Antigen generation, capture and presentation to lymphocytes• Effector mechanisms of cellular immunity• Antibody generation and antibody-mediated cytotoxicity• History and mechanisms of checkpoint-based therapeutic

approaches• Engineered cellular therapies – CAR-T and dendritic cells• Cancer vaccines

Instructor Biographies:

Masha Fridkis-Hareli, M.Sc., Ph.D., Founder and President, ATR, LLCMasha Fridkis-Hareli, M.Sc., Ph.D. is an immunologist, consultant

and inventor with over 20 years of experience in academia and industry. She is a Founder and President of ATR, LLC, a translational research company providing scientific consulting and laboratory services in immunoassay development to research institutions and the biotechnology industry. During her post-doctoral training at Harvard University she designed and developed a group of novel compounds for treatment of autoimmune diseases. After serving as Principal Investigator at the Dana Farber Cancer Institute, Dr. Fridkis-Hareli transitioned to industry where she held a variety of positions with increasing responsibilities at Resolvyx Pharmaceuticals, Charles River Laboratories, Taligen Therapeutics and Alexion Pharmaceuticals. Dr. Fridkis-Hareli is a co-author of over 100 publications and 17 issued patents. She is an adjunct professor at the Metropolitan College at Boston University, where she teaches biotechnology and immunology courses, and a co-chair of the Drug Discovery Working Group at the Massachusetts Biotechnology Council.

Each CHI Training Seminar offers 1.5 days of instruction with start and stop times for each day published in the onsite Program & Event Guide. Training Seminars will include morning and afternoon refreshment breaks, as applicable, and lunch will be provided to all registered attendees on the full day of the class.

Each person registered specifically for the Training Seminar will be provided with a hard copy handbook for the seminar in which they are registered. A limited number of additional handbooks will be available for other delegates who wish to attend the seminar, but after these have been distributed no additional books will be available.

Though CHI encourages track hopping between conference programs, we ask that Training Seminars not be disturbed once they have begun. In the interest of maintaining the highest quality learning environment for Training Seminar attendees, and because seminars are conducted differently than conference programming, we ask that attendees commit to attending the entire program, and not engage in track hopping, as to not disturb the hands-on style instruction being offered to the other participants.



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Preclinical and Translational Immuno-OncologyPredictive Preclinical Models for Cancer Immunotherapy


TUESDAY, AUGUST 29


TRANSLATIONAL IMMUNO-ONCOLOGY

1:15 Chairperson’s Opening RemarksLaurence Menard, Ph.D., Senior Research Investigator, Bristol‐Myers Squibb

1:20 Advances, Challenges and Future of Translational Systems Pharmacology in Cancer ImmunotherapySihem Bihorel, MS, Pharm.D., Ph.D., Assistant Professor, Department of Pharmaceutics, College of Pharmacy, University of FloridaTwo examples of quantitative systems pharmacology will be presented as they represent extremes of a spectrum of modeling complexity. The first example describes a hierarchical modeling approach where a large mechanistic mathematical model provided a framework to integrate a wide variety of experimental data, from in vitro observations to clinical trial results (bottom-up approach in QSP). The second example describes a modeling approach where the mechanistic model is connected to specific experimental data, which are acquired to inform the dynamic quantitative nature of the modeled biological system. Thus, the predictive power of the mechanistic model is more focused on a specific clinical question (top-down approach in QSP).

1:50 Generating Translational Hypotheses to Guide Development of IO TherapiesLaurence Menard, Ph.D., Senior Research Investigator, Bristol-Myers SquibbResponse rates to immuno-oncology therapies are still low in some types of cancers or subsets of patients. Thus, it is crucial to understand the immunologic heterogeneity of cancer patients in order to tailor the right medicine to the right patient. We have carried out a prospective immunologic analysis of cancer patients’ tumors and blood to generate testable hypotheses for tumor selection and patient stratification in clinical trials.

2:20 KEYNOTE PRESENTATION: Translation of Cancer Vaccines from Mice to Human Clinical TrialsJay A. Berzofsky, M.D., Ph.D., Chief, Vaccine Branch, Center for Cancer Research, National Cancer Institute, National Institutes of HealthWe translated two cancer vaccine platforms from mice to human clinical trials with promising results: 1) An epitope-enhanced TARP prostate cancer vaccine that induced human T cells that killed human cancer cells. In stage D0 prostate cancer patients, the vaccine reduced PSA slope measuring tumor growth rate in 74% of subjects at 1 yr (p = 0.0004). 2) An adenoviral vector HER2 vaccine cured mice with large established tumors and showed clinical benefit in 45% of evaluable advanced metastatic cancer patients with HER2+ tumors at the 2nd and 3rd dose levels.

Sponsored by2:50 Methods and Models to Evaluate Preclinical Radiation Treatment Strategies Maryland Franklin, Ph.D., Vice President, Scientific Development, MI Bioresearch

Sponsored by3:05 3D Spheroid Models of Fresh Patient Tumors: Ex vivo Analysis of Immune Microenvironment and Rational Combination TherapySoner Altiok, MD, Ph.D., CSO, Nilogen OncosystemsNilogen’s 3D-EX℠ platform utilizes fresh patient tumor tissue with intact microenvironment allowing for analysis of the interactions between the immune system and components of cancer tissue. We can accurately assess efficacy, identify rational combinations and develop companion diagnostics for biomarker-driven drug development and personalized medicine reducing both the cost and risk.


4:00 PLENARY KEYNOTE SESSIONClick here for details


5:30 Dinner Short Course Registration*SC1: Bioinformatics for Immuno-Oncology andTranslational Research SC 2: Microbiome in Immuno-Oncology*Separate registration required, please click here for details




PRECLINICAL MODELS FOR IMMUNOTHERAPY DEVELOPMENT

8:25 Chairperson’s RemarksLitao Zhang, Ph.D., Vice President, Leads Discovery and Optimization, Bristol-Myers Squibb

8:30 Using Mouse Models to Understand Tumor Genotypes in Shaping Up Tumor MicroenvironmentZhao Chen, Ph.D., Investigator III, Exploratory Immuno-Oncology, Novartis Institute of Biomedical ResearchTumor microenvironment plays a critical role in anti-tumor immune response. We are interested in the correlation between tumor microenvironment and a number of tumor cell autonomous properties, including key genetic alterations, tissue origins and tumor locations. By using appropriate animal models derived from isogenic cancer progenitors that represent different tissue origin, we are able to make some detailed comparisons.

9:00 Developing Humanized Mouse Models to Evaluate Antitumor Efficacy and Mechanism of Action in Cancer Immunotherapy StudiesCarmine Carpenito, Ph.D., Principal Scientist, ImClone Systems, Eli Lilly & Co.Immunodeficient mice permit the engraftment of human tumor and immune cells. These humanized xenograft models provide powerful tools to interrogate biological effects of human-specific immunomodulatory agents and provide important insights into their mechanism of action. We will describe different models and how they can be used to facilitate drug development in immuno-oncology.



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Preclinical and Translational Immuno-Oncology TUE-WED | AUGUST 29-30

9:30 Humanized Mouse Models for Preclinical Testing of Immune Checkpoint ModulatorsElla Ioffe, Ph.D., Associate Director, Immune-Oncology, Regeneron PharmaceuticalsImmune checkpoint receptors promote cancer immune tolerance by suppressing effector T cell activity. The development of immune checkpoint inhibitors has revolutionized cancer treatment. However, clinical antibodies against checkpoint receptors typically do not recognize murine proteins. Therefore, we developed mouse models where the therapeutic targets have been humanized using genetic engineering or reconstitution with primary human cells. These humanized models allow preclinical in vivo testing of fully human Regeneron antibodies.

10:00 Sponsored Presentation (Opportunity Available)

Sponsored by10:15 Human Tumor Micro- environment Models Support Evaluation and Prioritization of Combination Strategies for Immuno-OncologyAlison O’Mahony, Ph.D., Vice President, Research Biology, DiscoverX CorporationCombination and bi-specific therapies frequently achieve greater clinical benefit, however prioritizing these approaches over monotherapies can be challenging pre-clinically. BioMAP® human tumor-microenvironment models provide an evidence-based approach to qualify and guide these therapies via identification of differential IO-related immune activities, effects on TME and determining optimal exposures towards enhanced efficacy.


11:15 Evaluating Anti-Tumor Immune Responses in Preclinical Mouse ModelsMarcus Bosenberg, M.D., Ph.D., Associate Professor, Dermatology and Pathology, Yale School of Medicine; Co-Leader, Genomics, Genetics and Epigenetics Program, Yale Cancer CenterIdentification of autoimmune phenotypes in mice led to the development of anti-CTLA-4 and PD-1 drugs. While this approach has been very successful, there is great interest in overcoming resistance to checkpoint inhibitor therapy and in improving responses in cancers with low response rates. Testing of new immune therapeutic approaches in cancer requires models that accurately reflect responses in humans and allow for in-depth evaluation of mechanism of action.

11:45 KEYNOTE PRESENTATION: Accelerating Immuno-Oncology Drug Candidate Selection and Optimization: Dissecting Cancer Immunity Cycle through Quantitative and Advanced Immune Assay Technology PlatformsLitao Zhang, Ph.D., Vice President, Leads Discovery and Optimization, Bristol-Myers SquibbCancer immunity in nature requires the coordination of both immune stimulatory and inhibitory signaling mechanisms that occur in the tumor microenvironment. In this talk, we will share how to select right translational models to quantitatively monitor and characterize IO therapeutic agents. 3D bioprinting technology, co-culture systems and CRISPR will be used to model and mimic tumor microenvironment. Through these advanced technology platforms, biomarker profiling strategy will be discussed. The challenges and solutions to close the gaps in the IO drug discovery will be shared.

12:15 pm Profiling Protein Signaling and Functional Response of Checkpoint Inhibitor and Combination Treatments in Patient-Derived Tumor Immune Cell Co-Culture ModelsChristophe Sachse, Ph.D., Site Head Berlin, NMI TT PharmaservicesWe have established an ever-growing panel of primary patient-derived 3D co-culture models of tumor spheroids and T lymphocytes, which we employ in high-content assays for the evaluation of lymphocyte infiltration and T cell induced cytotoxic effects during in vitro drug testing. Also, our 3D models are analyzed by comprehensive DigiWest-based phospho-protein profiling of several transduction pathways, which yields in-depth data on cell signaling and adds considerable value beyond genomics analyses.

Sponsored by12:45 Luncheon Presentation: Advances in Immune-Checkpoint Inhibitors Therapies for the Treatment of Solid Tumors in Humanized Mouse ModelsPaula Miliani de Marval, Ph.D., Research Associate Director, Charles RiverThe need for more relevant preclinical models has led us to evaluate the antitumor efficacy of anti-CTLA-4 and anti-PD-1 checkpoint inhibitors in CD34+ and PBMC humanized mouse models. The findings of these studies will be discussed, along with the advantages and disadvantages of each model.

1:15 Session Break

TARGETING THE TUMOR MICROENVIRONMENT: ACTIVATING THE IMMUNE SYSTEM FOR BETTER RESPONSE TO IMMUNOTHERAPY

1:55 Chairperson’s RemarksPawel Kalinski, M.D., Ph.D., Professor, Oncology, Vice-Chair, Translational Research, Roswell Park Cancer Institute

2:00 Combinatorial Modulation of “Cold” Tumors to Promote Selective CTL Entry: Sensitization to PD-1/PD-L1 Blockers and VaccinesPawel Kalinski, M.D., Ph.D., Professor, Oncology, Vice-Chair, Translational Research, Roswell Park Cancer InstitutePresence of CTLs in tumor lesions predicts improved outcomes and patients’ responsiveness to checkpoint blockers. Combinatorial approaches, in contrast to mono-adjuvants, allow two levels of selectivity: 1) preferential activation of tumor microenvironments, rather than healthy tissues; 2) selective intratumoral induction of CTL-attracting chemokines, but suppression of Treg-attractants. Data from preclinical studies (ex vivo tissue explant cultures and mouse tumor models) and early-stage clinical trials will be discussed.

2:30 Emerging Investigator

Using Radiation to Elicit in situ Tumor VaccinationZachary S. Morris, M.D., Ph.D., Assistant Professor, Human Oncology, University of Wisconsin School of Medicine and Public HealthIn a syngeneic murine melanoma model, we recently reported an in situ vaccination response to combined radiation (RT) and intra-tumor (IT) injection of anti-GD2 hu14.18-IL2 immunocytokine (IC). This combined treatment resulted in 71% complete and durable regression of 5-week (~ 200mm3) tumors, a memory T cell response, and augmented response to systemic anti-CTLA-4 antibody (mAb) checkpoint blockade. We hypothesized that mice rendered disease-free (DF) by combined RT, IT-IC, and anti-CTLA-4 mAb might also exhibit an anti-tumor endogenous humoral response. Here we report an endogenous anti-tumor memory IgG humoral response in mice > 1 year after treatment with RT IT-IC and anti-CTLA-4 mAb. We demonstrate the emergence of this endogenous humoral response in the weeks following treatment and explore mechanisms whereby this response may contribute to the therapeutic efficacy and immunologic memory elicited by this in situ vaccination regimen.



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Preclinical and Translational Immuno-Oncology TUE-WED | AUGUST 29-30

3:00 Clinical Cancer Immunotherapeutic Approaches Utilizing STING-Activating Cyclic Dinucleotides and Live-Attenuated Listeria-Based Platforms to Target Tumor-Specific NeoantigensSarah McWhirter, Ph.D., Director, STING Program, Aduro BiotechInterventional strategies that combine tumor microenvironment (TME) remodeling with lymphocyte infiltration, induction of tumor-specific cellular immunity and blockade of immune checkpoint pathways can result in effective and durable anti-tumor efficacy. We have developed two clinical approaches, based on small molecule STING agonists and live-attenuated double-deleted Listeria monocytogenes (LADD) that accomplish these therapeutic goals. Preclinical and clinical immunotherapeutic regimens combining STING agonists and pLADD with immune checkpoint inhibitors will be discussed.



4:15 The Role of Batf-3 DC in the T Cell-Inflamed Tumor MicroenvironmentStefani Spranger, Ph.D., Assistant Professor, Biology, MITImmunotherapy has revolutionized the treatment of cancer, and while the number of cancers with responses towards immunotherapies is still growing, it has also been observed that only a fraction of

patients is responding within each cancer type. We investigated whether tumor cell-intrinsic signaling might dominantly impact local T cell infiltration and identified that patients with activated β-catenin signaling lack a productive anti-tumor T cell infiltrate. Mechanistically, we identified that β-catenin-positive tumors fail to recruit Batf3-driven dendritic cells into the tumor microenvironment. Detailed studies have identified that these dendritic cells are not only needed to activate anti-tumor specific T cells in the tumor-draining lymph node but are also required within the tumor microenvironment as the predominant source of effector T cell recruiting chemokines.

Emerging InvestigatorEmerging Investigator

4:45 Vaccine Therapy for Primary and Secondary Breast Cancer PreventionSasha Stanton, M.D., Ph.D., Acting Instructor, Breast Oncology, University of Washington Tumor Vaccine GroupVaccine therapy may both destroy ductal carcinoma in situ (DCIS) and prevent progression to invasive breast cancer (IBC). We have identified DCIS tumor associated proteins that are essential for breast cancer survival and immunogenic in DCIS. Furthermore, bexarotene, a rexinoic acid receptor agonist, can activate type 1 antigen presenting cells and induce a type 1 tumor immune environment. We are developing a multi-antigen polyepitope DCIS vaccine to determine if addition of bexarotene can improve vaccine efficacy.

5:15 Combining Targeted Radiation with ImmunotherapyJonathan D. Schoenfeld, M.D., MPhil, MPH, Assistant Professor, Radiation Oncology, Harvard Medical SchoolPreclinical data suggests targeted radiotherapy has immune stimulating effects that may increase the efficacy of immunotherapy. However, radiotherapy also has immune suppressive effects. In this session, we will review data that suggests that radiation may be a good partner for immunotherapy, and the types of radiation that are best suited for this purpose. We will also discuss emerging clinical data supporting the combination and ongoing and planned clinical trials.

5:45 Close of Preclinical and Translational Immuno-Oncology

Cambridge Healthtech Institute encourages attendees to gain further exposure by presenting their work in the poster sessions. To secure a poster board and inclusion in the conference materials, your abstract must be submitted, approved and your registration paid in full by July 28, 2017.

Reasons you should present your research poster at this conference: • Your poster will be seen by our international delegation,

representing leaders from top pharmaceutical, biotech, academic and government institutions

• Receive $50 off your registration • Your poster abstract will be published in our conference materials

PRESENT A POSTER AND SAVE $50!



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Emerging Immuno-Oncology TargetsNovel Targets and Pathways for Cancer Immunotherapy and Combinations


THURSDAY, AUGUST 31


IMMUNE CHECKPOINT INHIBITORS: BEYOND PD-L1

8:25 Chairperson’s Opening RemarksAngie Inkyung Park, Ph.D., Senior Director, Immunotherapy and Stem Cells, OncoMed Pharmaceuticals

8:30 TIM-3 Biology in Myeloid Cells and Implications for TIM-3 Blockade in Immuno-OncologyXiaomo Jiang, Ph.D., Investigator, Immuno-Oncology, Novartis Institutes for BioMedical ResearchTIM-3 has critical roles in tumor-induced immune suppression on a multitude of cell types. TIM-3 blockade to activate immune response and control tumor growth could reflect the combined effects on modulating not only the functional phenotype of dysfunctional effector T cells, but also inhibiting the suppressive activity of various suppressor cells.

9:00 Exploring Checkpoint Biology in Syngeneic Mouse ModelsFiona Sharp, Ph.D., Investigator II, Exploratory Immuno-Oncology, Novartis Institutes for BioMedical ResearchThe role of checkpoint proteins in regulating anti-tumor immunity has by now been well established for multiple proteins, including PD-1/PD-L1, LAG-3 and TIM-3. While the cellular and ligand interaction targets for some of these proteins are well defined, our knowledge of these aspects of TIM-3 requires further investigation. Gaining better insight into the key players in TIM-3 biology is central to enhancing the efficacy of this target in the clinic. Our studies have been focused on further exploring the key immune cells involved in TIM-3 controlled anti-tumor immune responses in syngeneic mouse models.

9:30 New Immune Checkpoints for Human Cancer ImmunotherapyXingxing Zang, Ph.D., Associate Professor, Microbiology and Immunology & Medicine, Albert Einstein College of MedicineCTLA-4 and the PD-1/PD-L1 pathway are current focuses for cancer immunotherapy. This presentation

will discuss other new immune checkpoints for future human cancer immunotherapy.


IMMUNOMODULATORY AGONIST TARGETS

10:45 Preclinical and Clinical Activity of the CD27 Agonist Antibody VarlilumabTibor Keler, Ph.D., Senior Vice President & CSO, Celldex TherapeuticsIn preclinical models, varlilumab’s agonist properties that lead to immune activation need to be coupled with its deleterious effect on Tregs to achieve potent antitumor activity across multiple models. A similar profile of immune activation and reduction in Tregs has been observed in cancer patients treated with varlilumab. Significant efforts are underway to correlate these biomarkers with clinical endpoints to inform dose and patient selection.

11:15 Preclinical Evaluation of GITR LigandAngie Inkyung Park, Ph.D., Senior Director, Immunotherapy and Stem Cells, OncoMed PharmaceuticalsA novel single-gene linkerless GITRL trimer fused to an immunoglobulin Fc domain (GITRL-Fc) was generated and tested for its anti-tumor activity in preclinical tumor models. GITRL-Fc showed potent anti-tumor activity in several preclinical tumor models by inducing Th1 biased anti-tumor immunity and reducing Treg-mediated immune suppression. Combination of GITRL-Fc with PD-1/PDL1 blockade significantly reduced the tumor growth in non-inflamed cold tumors. GITRL-Fc can improve cancer treatment by enhancing both innate and adaptive cellular immunity.


11:45 Targeting IDO1 to Enhance Cancer Immunotherapy: Not So Simple After AllDerek A. Wainwright, Ph.D., Assistant Professor, Departments of Neurological Surgery, Microbiology-Immunology, and Division of Hematology-Oncology, Northwestern University Feinberg School of MedicineIDO1 is canonically-recognized as an inducible enzyme that converts tryptophan into kynurenine. In cancer immunology, IDO1 has been associated

with contributing to immunosuppression of the anti-tumor immune response. However, tryptophan depletion and/or kynurenine accumulation does not fully account for IDO1-mediated immune evasion by cancer cells. Utilizing syngeneic and humanized mouse models of glioblastoma (GBM), in addition to the analysis of patient-resected tumors, new aspects of IDO1 will be described.

12:15 pm Sponsored Presentation (Opportunity Available)


1:15 Session Break

EMERGING TARGETS FOR COMBINATION IMMUNOTHERAPY

2:25 Chairperson’s RemarksJennifer Wu, Ph.D., Professor, Feinberg School of Medicine; Director, Cancer Immunology Program, Robert Lurie Comprehensive Cancer Center, Northwestern University

2:30 KEYNOTE PRESENTATION: Elements of Rational Combination Development in Cancer ImmunotherapyEdward Cha, M.D., Ph.D., Associate Medical Director, Cancer Immunotherapy Franchise, GenentechThe tumor microenvironment plays an important role in inhibiting the propagation of effective cancer immunity. Although PD-L1 is a critical source of immune suppression, additional elements in this environment also determine whether cancers successfully are eradicated or evade the immune response. This talk will focus on approaches to targeting immune escape mechanisms through novel agents and combinations, and on clinical designs that support more efficient discovery.

3:00 Pharmacodynamics and Antitumor Activity of the Adenosine 2A Receptor Antagonist AZD4635Rich Woessner, Ph.D., Principal Scientist, IMED



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THU-FRI | AUGUST 31-SEPTEMBER 1Emerging Immuno-Oncology Targets

Oncology, AstraZeneca PharmaceuticalsAZD4635 is a potent and highly selective antagonist of adenosine-mediated A2A receptor signaling, and inhibits T-cell function in ex vivo assays. In murine tumor models, oral administration of AZD4635 increases the expression of genes associated with immune activation, increases expression of co-stimulatory markers on antigen presenting cells, and enhances the antitumor activity of anti-PD-L1 antibody treatment. AZD4635 is in clinical evaluation as a single agent and in combination with the anti-PD-L1 antibody durvalumab.


4:00 Beyond Immune Checkpoint: Targeting Soluble NKG2D Ligands for Cancer ImmunotherapyJennifer Wu, Ph.D., Professor, Feinberg School of Medicine; Director, Cancer Immunology Program, Robert Lurie Comprehensive Cancer Center, Northwestern UniversityHuman tumor-derived soluble NKG2D ligand sMIC is highly immune suppressive and thus an emerging target for cancer immunotherapy. Using a clinically relevant mouse model, we show that therapy with the non-blocking sMIC-neutralizing antibody resulted in effective debulking primary tumors and eliminating metastases. Neutralizing sMIC also synergistically enhanced tumor response to PD-1 and CTLA4 immune checkpoint blockade therapy. These findings launched a new avenue of combination cancer immunotherapy.

4:30 KEYNOTE PRESENTATION: Bispecifics to the Rescue: Reviving Exhausted T Cells with Dual CostimulationRaphael Clynes, Ph.D., Vice President, Translational Biology, Xencor


5:00 Development of TGFβ Inhibitors for Immune-OncologyRikke Holmgaard, Ph.D., Senior Research Scientist, Eli LillyThe transforming growth factor β (TGFβ) signaling pathway is a pleiotropic cellular pathway that plays a critical role in cancer. In fact, aggressive tumors are typically associated with high ligand levels and thus associated with poor prognosis in various tumor types. Here we describe the identification of inhibitors targeting the TGFβ pathway and provide proof of concept data supporting the role of TGFβ in cancer and the utility of targeting the TGFβ pathway.

5:30 End of Day

6:00 Dinner Short Course Registration*

SC4: CRISPR/Cas9 Applications inImmunotherapy

*Separate registration required, please click here for details

FRIDAY, SEPTEMBER 1


EMERGING TARGETS FOR BISPECIFIC AGENTS

8:25 Chairperson’s Opening RemarksShane Olwill, Ph.D., Vice President, Head of Development & Immuno-Oncology, Pieris Pharmaceuticals GmbH

8:30 Costimulatory T-Cell Engagement by the 4-1BB/HER2 Bispecific PRS-343 for Tumor Localized Activation of the Immune SystemShane Olwill, Ph.D., Vice President, Head of Development & Immuno-Oncology, Pieris Pharmaceuticals GmbHPRS-343 is a bispecific monoclonal antibody/Anticalin fusion protein comprised of a HER2 tumor-targeting mAb genetically linked to a potent Anticalin specific for the immune costimulatory TNF family receptor 4-1BB (CD137). PRS-343 is being developed as the first 4-1BB based therapeutic to mediate the activation of tumor-specific T lymphocytes selectively within the tumor microenvironment (TME). 4-1BB is a potent costimulatory immunoreceptor and an established marker for tumor-specific infiltrating T lymphocytes (TILs), and is therefore, an attractive target for cancer immunotherapy. In in vivo preclinical tumor models, PRS-343 has demonstrated potent T lymphocyte activation localized to the TME of established HER2-positive tumors, indicating the potential for both enhanced safety and efficacy.


9:00 Dual Targeting Bispecific Antibodies Selectively Block Innate Immune Checkpoint Receptor CD47 on Tumor CellsStefano Majocchi, Ph.D., Research Scientist, Novimmune SACD47, a ubiquitously expressed innate immune checkpoint receptor that serves as a universal “don’t eat me” signal of phagocytosis, is often up-regulated by hematological and solid cancers to evade immune surveillance. We generated dual-targeting bispecific antibodies capable of selective inhibition of CD47 on malignant cells through co-engagement of a tumor-associated antigen (TAA). This dual-targeting approach exploits an innovative cancer immunotherapy mechanism while avoiding a poor pharmacological

half-life and potential hematological toxicities which are observed when CD47 is indiscriminately blocked. Such bispecific antibodies lead to TAA-dependent cancer cell killing through ADCP and ADCC in vitro and show anti-tumor activity in vivo associated with long pharmacokinetic half-life and absence of toxicity.


9:30 Predicting the Efficacy and Safety Profile of ImmTAC™ Molecules: The Preclinical ChallengeMartina Canestraro, Ph.D., Senior Scientist, Preclinical Biology, Immunocore, Ltd.ImmTAC™ molecules consist of an affinity enhanced T cell receptor fused to an anti-CD3 specific scFv. Since both ends of the molecule are human specific, standard species tox models are not appropriate for ImmTAC safety testing. This presentation will provide an overview of our technology and of the in vitro preclinical approach that was used to predict the safety and efficacy profile of our most advanced molecule IMCgp100, currently in Phase II clinical trials for the treatment of cutaneous and uveal melanoma.

10:00 Coffee Break

IDENTIFYING AND TARGETING TUMOR NEOANTIGENS

10:30 Discovery and Development of Novel Immunogenic Tumor Neoantigens for the Treatment of Solid TumorsPhilip M. Arlen, M.D., President & CEO, Precision Biologics, Inc.Immunogenic neoantigens were derived from a membrane preparation of pooled allogeneic colorectal cancer from patients undergoing surgery. Membrane fractions were isolated and tested for immunogenicity and utilized in a clinical trial in patients with chemotherapy refractory metastatic colorectal cancer. A positive correlation was observed in patients who were able to mount and sustain IgG responses to vaccine. Antibodies were screened using this vaccine and tested for sensitivity, specificity, and anti-tumor function. Neoantigens were identified in colon cancer with these functional antibodies.

11:00 Talk Title to be AnnouncedRoman Yelensky, Ph.D., CTO, Gritstone Oncology

11:30 High-Throughput Functional Screening of Neoantigens for Vaccines and TCR-Based Adoptive T Cell TherapiesDolores J. Schendel, Ph.D., CEO & CSO, Medigene AGNeoantigens are an important class of highly specific



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THU-FRI | AUGUST 31-SEPTEMBER 1Emerging Immuno-Oncology Targets

target molecules for various immunotherapies. In transiting from identification of mutant peptides by NGS and prediction of binding to HLA allotypes, Medigene explores high throughput technologies to functionally verify that predicted neoantigens do in fact lead to T cell recognition. Our rapid methods bypass the need for patient cells, overcoming logistical restrictions for determining the true immunogenicity of predicted neoantigens.

12:00 pm Close of Emerging Immuno-Oncology Targets



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Adoptive T Cell Therapy





Therapy



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Oncolytic Virus ImmunotherapyCommercializing the Exciting Potential of Oncolytic Virotherapy


MONDAY, AUGUST 28


LATEST UPDATES AND FUTURE DIRECTIONS IN ONCOLYTIC VIRUS IMMUNOTHERAPY

8:25 Chairperson’s Opening Remarks Brian R. Champion, Ph.D., CSO, Psioxus TherapeuticsLtd.

8:30 KEYNOTE PRESENTATION: Engineering and Bio-Selection to Optimize an Oncolytic Virus PlatformJohn Bell, Ph.D., Senior Scientist, Center for Innovative Cancer Research, Ottawa Hospital Research InstituteOncolytic viruses are therapeutics that are designed or selected to specifically infect and destroy cancer cells. There are multiple strategies that can be employed to create viruses that replicate in and kill tumors; however, one common feature of malignant cells is that they lack a potent anti-viral response. I will discuss the molecular basis for these defects, how best to exploit them to create tumor killing therapeutics and strategies to improve manufacturing output of oncolytic viruses from manufacturing cell lines based upon these principles.

IMPROVING THE TARGETING AND EFFICACY OF ONCOLYTIC VIRUSES

9:00 Tumor Selective HSV-Based Oncolytic Vectors for Treatment of GBMPaola Grandi, Ph.D., Senior Research Director, Immunology/Virology, Oncorus, Inc.Oncorus oHSV is controlled by certain microRNAs (miRNAs) that are present in healthy cells, but absent in cancer cells. Typically, miRNAs regulate the ability of classical messenger RNA (mRNAs) to be translated into protein or promote the degradation of mRNAs. By engineering miRNA binding sites into essential viral genes, oHSV replication and cellular destruction is prevented in healthy cells. Since cancer cells lack these specific miRNAs, Oncorus oHSV is free to replicate in and destroy them.

Sponsored by

9:30 Coffee Break

10:00 WO-12, a Multi-Mechanistic Immuno-Oncolytic TherapySteve H. Thorne, CSO, Western Oncolytics Ltd.The next generation of oncolytic viruses will likely combine multiple genetic modifications (transgenes and viral genetic alteration) that act to synergistically target tumors through multiple mechanisms. In particular, approaches that (i) enhance systemic delivery and viral spread within and between tumors, (ii) activate a potent anti-tumor T-cell response, and (iii) modify the tumor microenvironment to enhance the activity of both the viral therapy and other therapies would produce additional benefits. The Western Oncolytics platform and its lead product WO-12 aim to achieve these goals. WO-12 has demonstrated enhanced activity in preclinical models and will soon enter clinical testing.

10:30 Pepticrad, a Novel Oncolytic Virus-Based Therapeutic Cancer VaccineSari Pesonen, Vice President, Clinical Development, Valo TherapeuticsPeptiCRAd (Peptide-coated Conditionally Replicating Adenovirus) is an innovative and unique way of combining two clinically proven cancer immunotherapy approaches: an oncolytic adenovirus and a cancer-specific peptide vaccine, to take advantage of the best features of both technologies. The idea is straightforward: to use immunogenic virus as active carrier of tumor-specific peptides to direct the immune system to specifically target and kill cancer cells.

11:00 Synthetic Virology: Modular Assembly of Designer Viruses for Cancer TherapyClodagh O’Shea, Ph.D., Howard Hughes Medical Institute Faculty Scholar; Associate Professor, William Scandling Developmental Chair, Molecular and Cell Biology Laboratory, Salk Institute for Biological StudiesDesign is the ultimate test of understanding. For oncolytic therapies to achieve their potential, we need a deep mechanistic understanding of virus and tumor biology together with the ability to confer new properties. To achieve this, we have developed combinatorial modular genome assembly (ADsembly) platforms, orthogonal capsid functionalization technologies (RapAd) and replication assays that

have enabled the rational design, directed evolution, systematic assembly and screening of powerful new vectors and oncolytic viruses.

11:30 Adenovirus-based virotherapy for disseminated diseaseDavid T. Curiel, MD, PhD., Distinguished Professor of Radiation Oncology, Director, Biologic Therapeutics Center, Washington UniversityEffective virotherapy for disseminated neoplastic disease required precise tumor targeting. The unique molecular plasticity of adenovirus offers the potential to achieve the tumor selectivity required for virotherapy for metastatic disease.


12:30 Session Break

ONCOLYTICS IN DEVELOPMENT: UPDATE ON MAJOR CLINICAL AND PRECLINICAL THERAPIES

1:25 Chairperson’s RemarksFares Nigim, M.D., Massachusetts General Hospital and Harvard Medical School


1:30 Development of OV Immunotherapy Using a Novel Preclinical GBM ModelHiroshi Nakashima, Ph.D., Instructor, Neuroscience, Brigham and Women’s HospitalMechanism of action of the Oncolytic virus includes direct tumor killing and vaccine adjuvant. Since OV immunotherapy is emerge to apply in incurable glioblastoma multiforme (GBM) for the durable therapeutic effects, our new glioma mouse model will provide new opportunity to evaluate the combined OV therapies that work under the patient-mimicked immunological condition.2:00 Stroma Targeting Strategies for Oncolytic Virotherapy Daniel Katzman, PhD., CEO, Unleash Immuno Oncolytics



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Oncolytic Virus Immunotherapy MON-TUE | AUGUST 28-29

2:30 Pexa-Vec: A Multi-Mechanistic Immunotherapeutic Modulator of the Tumor MicroenvironmentNaomi De Silva, Associate Director, Preclinical Science, Sillajen Biotherapeutics, Inc.Pexa-Vec (pexastimogene devacirepvec, JX-594) is an oncolytic and immunotherapeutic vaccinia virus, engineered to preferentially infect tumor cells, disrupt vasculature, and stimulate anti-tumor immune responses. A Phase III trial evaluating Pexa-Vec in the treatment of advanced primary liver cancer is underway.

Sponsored by3:00 Refreshment Break

3:30 Designing Clinical Trials to Elucidate Oncolytic Virus Mechanisms-of-ActionCaroline Breitbach, Ph.D., Vice President, Translational Development, Turnstone BiologicsOncolytic viruses have been shown to target tumors by multiple complementary mechanisms-of-action, including direct oncolysis, tumor vascular targeting and induction of anti-tumor immunity. Phase I/II clinical trials can be designed to validate these mechanisms. Development experience of an oncolytic vaccinia virus and a novel rhabdovirus oncolytic vaccine will be summarized.

CMC, SCALE-UP AND COMMERCIAL MANUFACTURING

4:00 Development of an Attenuated Oncolytic Influenza a Virus Expressing Mycobacterial ESAT-6 ProteinMichael Bergmann, M.D., Ph.D., CMO, VactheraWe have expressed ESAT-6 in a partial NS1-deletion influenza virus. ESAT-6 expressing viruses were associated with lower levels of NF-kB activating as compared to empty viral vectors. ESAT-6 expressing viruses led to higher titers in eggs up to 1010 TCID50. ESAT-6 expressing deletion viruses were still attenuated when applied to the upper respiratory tract of mice. Intra-tumoral application of virus into B16 melanoma significantly delayed tumor growth.

4:30 Testing and Characterization of Oncolytic VirusesJerrod Denham, Ph.D., Principal & Senior Consultant, Dark Horse ConsultingTesting and characterization of oncolytic viruses typically follow the current principles for the majority of gene therapy product critical quality attributes. There are specific challenges with respect to adventitious agent safety testing and viral clearance studies. This presentation will walk through examples of how these challenges were resolved.

5:00 End of Day

TUESDAY, AUGUST 29



ONCOLYTICS IN AN ERA OF COMBINATION THERAPIES

8:25 Chairperson’s Opening RemarksMatthew Mulvey, Ph.D., CEO, BeneVir Biopharm, Inc.

8:30 Rationale for Oncolytic Viruses as the Backbone of Combination Immunotherapy RegimensRobert Coffin, PhD., Co-founder and CEO, ReplimuneOncolytic viruses (OVs) mediate anti-tumor activity through direct cell lysis and induction of host anti-tumor immunity. The ability to attract and activate T cells within the tumor microenvironment and induce interferon release suggests that OVs could be used as the backbone in combination immunotherapy strategies designed to promote anti-tumor immunity. Emerging clinical data is demonstrating significant improvement in studies of melanoma, and further clinical development for other cancers is anticipated.

9:00 FEATURED PRESENTATION: Developing Tumor-Specific Immunogene (T-Sign) Combination Immunotherapies by Arming the Oncolytic Group B Adenovirus EnadenotucirevBrian R. Champion, Ph.D., CSO, Psioxus Therapeutics Ltd.We have developed a broadly applicable platform system, based on the potent chimeric oncolytic adenovirus enadenotucirev (EnAd), for directing the selective localized production of a combination of immunotherapeutic agents within tumors following systemic dosing, while minimizing the potential for systemic off-target effects of such combination approaches. The presentation will highlight recent data supporting both the platform and specific T-SIGn virus candidates.

9:30 T-Stealth Technology Promotes Synergy between Oncolytic Viruses and Immuno-Stimulatory AgentsMatthew Mulvey, Ph.D., CEO, BeneVir Biopharm, Inc.BeneVir is developing an OV platform based on T-Stealth Technology, which hides infected cells from anti-viral T-cells. This allows an OV to complete its replication program, produce progeny viruses, and spread in the tumor microenvironment despite a robust anti-viral T-cell response. In immune-competent murine tumor models, regimens that simultaneously combine immuno-stimulatory agents with T-Stealth armed OV show efficacy. However, there is no effect on tumor burden in these models when simultaneous combination regimens utilize a “Visible” OV that does not encode T-Stealth Technology. BeneVir’s lead OV will enter a Phase I trial in solid tumors in Q2 2018.



11:15 What Does It Take to Cure Glioblastoma; Combinations Plus?Samuel D. Rabkin, Ph.D., Professor, Neurosurgery, Massachusetts General Hospital and Harvard Medical SchoolWe will discuss combination therapies for glioblastoma in representative preclinical models, involving oncolytic herpes simplex viruses (oHSV), cytokine expression, and immune checkpoint inhibitors. OHSV induce anti-tumor immunity and can be armed with therapeutic transgenes. The complex multicomponent strategy illustrates both the



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Oncolytic Virus Immunotherapy MON-TUE | AUGUST 28-29

difficulty in treating non-immunogenic tumors and the opportunities in coupling immunovirotherapy with other immunotherapeutic approaches.


11:45 Oncolytic Virus-Induced Rad51 Degradation: Synergy with Poly(Adp-Ribose) Polymerase Inhibitors in Treating GlioblastomaJianfang Ning, Ph.D., Instructor, Neurosurgery, Massachusetts General Hospital, Harvard Medical SchoolOncolytic herpes simplex virus (oHSV) sensitized glioblastoma stem cells (GSCs) to poly(ADP-ribose) polymerase inhibitors (PARPis), irrespective of their PARPi sensitivity through selective proteasomal degradation of key DNA damage response protein, Rad51, mediating the combination effects. This synthetic lethal-like interaction increased DNA damage, apoptosis, and cell death in vitro and in vivo. Combined treatment of mice bearing PARPi-sensitive or -resistant GSC-derived brain tumors greatly extended survival compared to either agent alone.

12:15 pm Close of Oncolytic Virus Immunotherapy



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Adoptive T Cell TherapyDelivering CAR, TCR, and TIL from Research to Reality


TUESDAY, AUGUST 29


KEYNOTE SESSION PART I: WHAT’S NEW IN ADOPTIVE CELL THERAPY

1:15 Chairperson’s Opening RemarksAdrian Bot, M.D., Ph.D.,Vice President, Translational Research, Kite Pharma

1:20 Building Better T Cell Therapies: The Power of Molecular ProfilingMark Bonyhadi, Ph.D., Head, Research and Academic Affairs, Juno TherapeuticsChimeric antigen receptor (CAR)-T cells are a promising new modality for cancer immunotherapy and many variants are rapidly being developed across the immuno-oncology space for haematological and solid tumor malignancies. The field has displayed enormous promise, however the rules governing which attributes drive efficacy are still being learned. Here, we present early insights from transcriptomic and epigenetic profiling of CAR-T cells describing how cell state may play an important role.

1:50 Tricked-Out Cars, the Next Generation of CAR T CellsRichard Morgan, Ph.D., Vice President, Immunotherapy, Bluebird BioGenetically-engineered CAR T cells are designed to supplement a patient’s immune system and can be further engineered to survive and overcome immune evasion mechanisms employed by tumors. We found that addition of a PI3-kinase inhibitor during manufacturing enriched for memory-like CAR T cells without complicated cell sorting procedures. These methodologies, combined with synthetic biology and gene editing, can be considered for the further development of CAR T cell technology.

2:20 SPEAR T Cells for Solid Tumor TherapyMark Dudley, Ph.D., Senior Vice President, Bioprocessing, AdaptimmuneAdoptive cell transfer with gene modified T lymphocytes is effective for some advanced cancer indications. Specific peptide engineered antigen receptor (SPEAR) T cells that recognize the NY-ESO-1 cancer-testes antigen have shown promise in early phase trials for melanoma, multiple myeloma, and synovial sarcoma. Combination therapies and product improvements are being explored, and a registration trial is planned. Numerous tumor antigen candidates predicted from proteomic and HTS analysis of tumor specimen NAS have been used to generate new SPEAR T cells. T cells targeting MAGE-A10, MAGE-A4, and AFP are approved for initial evaluation in clinical trials in new solid tumor indications in 2017. A robust manufacturing platform that generates multiple SPEAR products for exploratory registration studies will be discussed. Challenges in scaling out successful autologous cell therapies and opportunities for implementing automation and improving T cell products will be assessed.

Sponsored by2:50 The Generation of Lentiviral Vector-Modified CAR-T Cells Using an Automated ProcessBoro Dropulic, Ph.D., General Manager and CSO, Lentigen Technology, Inc.Participants will learn about: 1) How Lentiviral vectors are a proven robust technology to genetically modify cells 2) The Development of a large-scale lentiviral vector manufacturing process using a chemically defined, serum free suspension bioreactors 3) How automation using the CliniMACS Prodigy is a robust and cost effective method to generate patient specific CAR-T cells 4) The design and testing of CAR constructs - factors that influence in vivo efficacy 5) How automation provides options for the manufacture of CAR-T cell products: Centralized vs Decentralized models.




5:30 Dinner Short Course Registration*SC1: Bioinformatics for Immuno-Oncology and Translational ResearchSC 2: Microbiome in Immuno-Oncology*Separate registration required, please click here for details




PART II: AUTOLOGOUS IMMUNE CELL PRODUCTS

8:10 Chairperson’s RemarksMark Bonyhadi, Ph.D., Head, Research and Academic Affairs, Juno Therapeutics

ADOPTIVE CELL THERAPY USING NON-GENETICALLY MANIPULATED LYMPHOCYTES

8:15 The End Game: Adjuvant γδ T Cell-Based Strategies for Consolidation and Eradication of Residual CancerLawrence S. Lamb, Jr., M.N., Ph.D., Professor, Medicine; Director, Cell Therapy Laboratory, University of Alabama at BirminghamExpanded and activated γδ T cells can significantly extend relapse-free survival (RFS) in human and animal studies of hematopoietic and solid cancers. Using glioblastoma multiforme (GBM) as a model, we show that simultaneous chemotherapy-induced upregulation of NKG2DL expression and infusion of chemotherapy-resistant gene-modified γδ T cells can result in significant RFS in a patient-derived xenograft model. We will discuss translation and early trials of these strategies in leukemia and GBM.



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Adoptive T Cell Therapy TUE-WED | AUGUST 29-30

9:00 Personalized Adoptive Cell Therapy Using Novel XPRESIDENT® Derived TargetsAli Mohamed, Ph.D., Vice President, CMC, Immatics US, Inc.The lack of safe and validated targets is a major limitation for the translation of cancer immunotherapy to solid tumor indications. The XPRESIDENT® approach allows access to a novel target space using a combination of ultra-sensitive quantitative mass spectrometry, transcriptomics, immunology and bioinformatics based on the immunopeptidome of human normal and tumor tissues. We present two complementary adoptive cell therapy approaches that are based on using multiple XPRESIDENT® derived targets

Sponsored by9:30 Vector Manufacturing for T Cell TherapiesKlaus Kühlcke, Managing Director, EUFETS GmbHManufacturing technologies for high titer batches of safety-optimised retroviral vectors will be presented.

9:45 Sponsored Presentations (Opportunities Available)


ADOPTIVE CELL THERAPY USING CHIMERIC ANTIGEN RECEPTORS (CAR) AND T CELL RECEPTORS (TCR)


11:15 PET-Imaging of Chimeric Antigen Receptor T CellsDavid Huss, Ph.D., Senior Scientist, CAR T Cell Team Lead, Juno Therapeutics

11:45 Immunotherapy for Ovarian Cancer: One Cell at a TimeWendy J. Fantl, Ph.D., Assistant Professor, Obstetrics and Gynecology, Stanford University School of MedicineMultiple studies indicate that high grade serous ovarian cancer (HG-SOC) is an immunogenic tumor and can be recognized by the host immune system, yet only a subgroup of HG-SOC patients respond to immunotherapy. Here we will leverage the power of multi-parameter single cell mass cytometry to simultaneously characterize the tumor and immune cell compartments of HG-SOC tumors to discover new mechanistic biomarkers predictive of response and resistance to immunotherapy.

12:15 pm Engineering the Future of Cellular Therapy: Current Perspectives and Future DirectionsMatthew Frigault, M.D., Post-Doctoral Fellow, Cellular Immunotherapy, Dana-Farber Cancer InstituteThe last few years have been an exciting time for cellular therapy. CAR-T cells have offered hope for many otherwise treatment refractory patients. With the recent filing for the first FDA-approved CAR-T cell it appears that CAR-T cell therapy is here to stay. This talk will discuss additional advances in our understanding of CAR-T cell biology and genetic engineering that offer a promising future for this maturing technology.


1:15 Session Break

1:55 Chairperson’s RemarksRichard Morgan, Ph.D., Vice President, Immunotherapy, Bluebird Bio

2:00 Cytotherapy with Targeted Allogenic NK CellsLaurent Boissel, Ph.D., Associate Director, Research & Development, NantKwest, Inc.NantKwest has developed the NK cell line NK-92 into an “off-the-shelf” activated NK (aNK) cell therapeutic. The safety of aNK as well as their activity against a broad range of cancers have been confirmed in Phase I trials in the U.S., Canada and Europe. aNK cells can be administered in the outpatient setting and serve as a universal cell-based therapy without need for individualized patient matching. aNK cells have been bioengineered to incorporate a high antibody binding Fc-receptor (haNK). Both aNK and haNK cells can be equipped with chimeric antigen receptors (CARs) (called taNK) to further optimize targeting and potency in the therapeutic setting.

2:30 IMPACT Fusion Proteins Redirect CAR19 T Cell Cytotoxicity to Diverse Tumor AntigensPaul Rennert, Ph.D., President and CSO, Aleta Biotherapeutics Inc.We present a strategy to leverage sustained CD19 presentation by normal B cells to promote CAR19 T cell expansion and persistence while also redirecting their cytotoxic activity to other (non-CD19) targets via secreted fusion proteins. The technology, called IMPACT (Integrated Modules Optimize Adoptive Cell Therapy) is modular in design and can be applied to diverse antigens and tumor types. The strength of the technology is demonstrated using Her2+, BCMA+ and ROR1+ tumors.

3:00 Advancement from Boutique to Global in the 20th Year of Chimeric Antigen Receptor T Cell TrialsBruce Levine, Ph.D., Barbara and Edward Netter Professor, Cancer Gene Therapy, University of Pennsylvania Perelman School of MedicineCAR T cells have demonstrated robust and durable clinical responses in relapsed and refractory malignancies. CAR T cell design includes elements of the receptor design, gene delivery to T cells, as well as the sourcing, manufacture, testing, delivery, and administration of the final CAR T cell product followed by clinical management of the patient. Each of these elements provides unique challenges in an autologous drug, where the size of the lot is 1. CAR T cells targeting new targets in hematologic malignancies and in solid tumors are underway and provide demonstration that it is possible to design immunity at will for therapeutic application.




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Adoptive T Cell Therapy TUE-WED | AUGUST 29-30

PART III: ALLOGENEIC IMMUNE CELL PRODUCTS

4:15 CD1d-Restricted NKT Cells as a Platform for Off-the-Shelf Cancer ImmunotherapyLeonid S. Metelitsa, M.D., Ph.D., Professor, Pediatrics and Immunology, Texas Children’s Cancer Center, Center for Cell & Gene Therapy, Baylor College of MedicineThe immunosuppressive tumor microenvironment (TME) impairs T-cell localization and persistence, posing a critical challenge to the development of adoptive cancer immunotherapy. My presentation will elucidate a new class of cellular immunotherapy that exploits unique natural and engineered TME-targeting properties of CD1d-restricted NKT cells. Because CD1d is monomorphic and allogeneic NKTs do not induce graft-versus-host disease, banked NKTs engineered to express chimeric antigen receptors can be used for “off-the-shelf” cancer immunotherapy.

4:45 TALEN Gene Editing for “Off-the-Shelf” Allogeneic CAR T Cell ProductsJulianne Smith, Ph.D., Vice President, Translational Science, CellectisCellectis developed a platform for generating chimeric antigen receptor (CAR)-redirected T cells from third-party healthy donors TALEN® gene editing technology. Nuclease mediated inactivation of TCR alpha abrogates the potential for T cells bearing alloreactive TCRs to mediate Graft versus Host Disease (GvHD). Additional gene inactivation events can be incorporated, permitting resistance to lymphodepleting or chemotherapeutic agents, tumor inhibition or suppression of cross T cell reactions. Such allogeneic “off-the-shelf” CAR T cell products will permit a wider application of CAR technology and lead to a new paradigm in cancer treatment.

5:15 Close of Adoptive T Cell Therapy



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Personalized Cancer Vaccines and Neoantigen Targeted TherapiesPersonalized Cancer Immunotherapy in the Genomic Era


THURSDAY, AUGUST 31


COMBINING CANCER VACCINES WITH IMMUNE CHECKPOINT BLOCKADE

8:25 Chairperson’s Opening RemarksJoshua Brody, M.D., Director, Lymphoma Immunotherapy Program, Icahn School of Medicine at Mount Sinai

8:30 Discovery of the Best Checkpoint Blockade Partner for in situ VaccinationJoshua Brody, M.D., Director, Lymphoma Immunotherapy Program, Icahn School of Medicine at Mount SinaiCheckpoint blockade therapy has had tremendous impact, but for many tumors, despite sufficient tumor antigen load, suboptimal cross-presentation of these antigens precludes effective CD8 T cell activation. To address this problem, we developed a novel in situ vaccine combining intratumoral Flt3L to recruit DC, radiotherapy to load DC with TAA, and intratumoral TLR agonist to activate loaded DC. An early phase trial testing this approach has demonstrated partial and complete systemic tumor regressions at distant (untreated) tumors. Ongoing work is focused on discovery of the optimal checkpoint blockade to combine with this approach.

9:00 Cancer Vaccines in the Era of Checkpoint BlockadeWillem W. Overwijk, Ph.D., Professor, Melanoma Medical Oncology, The University of Texas MD Anderson Cancer CenterRecent developments in T cell checkpoint blockade therapy, next-generation sequencing and molecular immunobiology open new possibilities and new questions for cancer vaccines. Based on clinical data and animal models, we discuss where cancer vaccines fit in the current clinical landscape of immune-based therapies, which antigens should go into a personalized cancer vaccine, what makes a powerful cancer vaccine adjuvant, and what could move cancer vaccines from “promising” to “effective.”

9:30 Driving CD8+ T Cell Responses to Mutational Neoantigens in Tumors – Harnessing Immunogenic Viral VectorsKarin Jooss, CSO, Gritstone OncologyDNA damage may cause mutations in tumors that can generate new antigens (TSNAs), which were identified to be T-cell targets in clinical responders on immune checkpoint therapy. To increase responder frequency in clinic, Gritstone Oncology is applying a proprietary model that accurately identifies TSNAs and seeks to deliver them in the context of potent viral vector-based vaccine platforms which have shown to induce hi-titer, polyfunctional and durable CD4+ and CD8+ T-cell responses in humans. The personalized vaccine is delivered in combination with immune checkpoint blockade, to keep TSNA-induced T cells active in the immunosuppressive tumor microenvironment.


DENDRITIC CELL IMMUNOTHERAPY

10:45 KEYNOTE PRESENTATION: Genetically Engineered DC Vaccines for MelanomaLisa H. Butterfield, Ph.D., Professor, Medicine, Surgery and Immunology, University of PittsburghCancer vaccines are designed to promote antitumor immunity. There are many approaches which have been tested clinically: different forms of antigens, different adjuvants, DNA and RNA, viral vectors and allogeneic or autologous cells. Dendritic cells (DC) have been tested in many forms, with strong evidence for immunogenicity and limited evidence for clinical activity. We recently completed a DC vaccine trial with antigen-engineered autologous DC for melanoma, and immune monitoring results will be presented.

11:15 Development of ICT-107, a Novel Dendritic Cell Immunotherapy against GlioblastomaSteven J. Swanson, Ph.D., Senior Vice President, Research, ImmunoCellular Therapeutics, Ltd.

ICT-107 is a novel dendritic cell immunotherapy targeting cancer stem cells that is being evaluated in a Phase III trial in newly diagnosed glioblastoma. The results from the early clinical trials influenced the design of the multi-center international Phase III trial. The design, manufacturing challenges, survival data, and immune monitoring data for ICT-107 are described.

11:45 Dendritic Cell Immunotherapy for Solid TumorsMarnix Bosch, Ph.D., CTO, Northwest BiotherapeuticsThe capacity of dendritic cells (DCs) to initiate adaptive immune responses can be harnessed for cancer immunotherapy purposes. Northwest Biotherapeutics has developed two product lines in which autologous DCs are utilized to present tumor antigens to the immune system, with the goal to affect tumor growth and extend patients’ lives in the absence of significant toxicity. These products are being tested in both late stage and early stage clinical trials in which both the efficacy of the products as well as the scientific underpinnings of the technology are being further evaluated.

Sponsored by12:15 pm ctDNA Guided Drug DevelopmentKalidip Choudhury, Ph.D., Head, Search and Evaluation, Natera, Inc.There is an urgent need to increase the efficacy of current oncology therapy and better target its use. An attractive feature of liquid biopsies is the potential to monitor tumor progression and response to therapy in a minimally invasive manner. We discuss our recent findings on the use of patient specific ctDNA profiling to characterize the subclonal dynamics of solid tumors and identify drug resistance. These studies indicate that drug development guided by ctDNA platforms to identify residual disease, define adjuvant treatment response and target emerging subclones are now feasible.


1:15 Session Break



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THU-FRI | AUGUST 31-SEPTEMBER 1Personalized Cancer Vaccines and Neoantigen Targeted Therapies

DESIGNING EFFECTIVE PERSONALIZED CANCER VACCINES: TARGETING PATIENT-SPECIFIC NEOANTIGENS

2:25 Chairperson’s RemarksKeith Knutson, Ph.D., Director, Cancer Vaccine & Immune Therapies Program, Mayo Clinic

2:30 Presentation to be Announced

3:00 Talk Title to be AnnouncedLelia Delamarre, Ph.D., Group Leader, Cancer Immunotherapy Department, Genentech


4:00 In vivo Delivery of Multiple Conserved Tumor Antigens, Neoepitopes and Immune Response Enhancers with Dendritic Cell Targeting Lentiviral Vector ZvexmultiJan ter Meulen, M.D., CSO, Immune DesignGiven the current limitations of accurately predicting immunogenic CD4 and CD8 T-cell tumor neoepitopes, we propose that a patient-specific combination of multiple neoepitopes and conserved tumor antigens may increase the efficacy of immunotherapy. To this end, we have modified our dendritic-cell targeting integration deficient lentiviral vector platform ZVex to express any combination of antigens and immune-enhancers concomitantly. ZVexMulti is a novel plug-and-play system for rapid generation of fully personalized cancer immunotherapies.

4:30 Generation of Cost-Effective and Immunogenic Private Neoantigen-Based DNA VaccinesAgnete Fredriksen, Ph.D., CSO, VaccibodyDNA vaccines represent an attractive vaccine format for manufacturing patient-specific neoantigen-based vaccines on demand due to its robust, cost-effective and rapid manufacturing method. Vaccibody has developed a unique platform technology able to substantially potentiate DNA vaccines by targeting neoantigens to antigen presenting cells, without increasing manufacturing complexity. Custom-made neoepitope prediction tools validated by in vivo studies are used to optimize chances of clinical efficacy in the upcoming clinical study.

5:00 Autosynvax™ (ASV™), a Personalized Second Generation Vaccine PlatformJean-Marie Cuillerot, M.D., CMO, AgenusAutoSynVax™ (ASV™) vaccines contain patient-specific peptides with defined immunogenic epitopes resulting from specific mutations within a patient’s tumor, deduced using a proprietary algorithm, complexed

with a recombinant HSP molecule (HSC70) and delivered with a saponin-based adjuvant. Preclinical studies demonstrate that heat shock protein-driven presentation of synthetic tumor neo-peptides evokes an anti-tumor immune response as well as lasting immune memory in murine cancer models.

5:30 End of Day

6:00 Dinner Short Course Registration*SC4: CRISPR/Cas9 Applications in Immunotherapy*Separate registration required, please click here for details

FRIDAY, SEPTEMBER 1


IDENTIFYING AND TARGETING TUMOR NEOANTIGENS

8:25 Chairperson’s Opening RemarksPhilip M. Arlen, M.D., President & CEO, Precision Biologics, Inc.

8:30 KEYNOTE PRESENTATION: Broad Coverage HLA-DR Subdominant Neoepitope-Based Cancer VaccinesKeith Knutson, Ph.D., Director, Cancer Vaccine & Immune Therapies Program, Mayo ClinicVaccines that elicit helper T cells are effective in preventing tumor growth. Dominant class II epitopes drive tolerance through the generation of Tregs. There is a T cell repertoire to subdominant epitopes, the latter of which are presented during aberrant protein expression such as in tumors. We have developed pathways for identifying subdominant class II epitopes that bind promiscuously to HLA-DR molecules, establishing broad coverage helper T cell-inducing cancer vaccines.

9:00 Leveraging the Neo-Repertoire of Tumor-Specific Th1 Epitopes for Multiantigen Cancer VaccinesWilliam Watt, Ph.D., President & CEO, EpiThanyThe “right” epitope in a tumor antigen can anchor an effective immune response and a tailored combination immunotherapy. Mutated neo-epitopes arise stochastically in some cancers and can be captured in real time as a tumor grows. EpiThany leverages epitopes that arise via the over-expression of established tumor antigens. By selecting antigens a priori and predicting epitopes in silico, we produce off-the-shelf vaccines against multiple antigens specific for the targeted tumors.

9:30 Comprehensive Profiling of T Cell Responses to Putative Neoantigens Reveals Smarter Targets for Cancer ImmunotherapyTheresa Zhang, Ph.D., Vice President, Personalized Cancer Vaccines, Genocea BiosciencesATLAS is a high throughput, ex vivo platform that industrializes T cell response profiling. It enables unbiased, comprehensive identification of antigens for both CD8+ and CD4+ T cells in any patients regardless of their HLA genotypes. Case studies will be discussed where ATLAS is utilized to identify the right T cell antigens for better neoantigen vaccine and to profile T cell response that could predict efficacy of checkpoint blockade therapy.

10:00 Coffee Break

10:30 Discovery and Development of Novel Immunogenic Tumor Neoantigens for the Treatment of Solid TumorsPhilip M. Arlen, M.D., President & CEO, Precision Biologics, IncImmunogenic neoantigens were derived from a membrane preparation of pooled allogeneic colorectal cancer from patients undergoing surgery. Membrane fractions were isolated and tested for immunogenicity and utilized in a clinical trial in patients with chemotherapy refractory metastatic colorectal cancer. A positive correlation was observed in patients who were able to mount and sustain IgG responses to vaccine. Antibodies were screened using this vaccine and tested for sensitivity, specificity, and anti-tumor function. Neoantigens were identified in colon cancer with these functional antibodies.

11:00 Talk Title to be AnnouncedRoman Yelensky, Ph.D., CTO, Gritstone Oncology

11:30 High-Throughput Functional Screening of Neoantigens for Vaccines and TCR-Based Adoptive T Cell TherapiesDolores J. Schendel, Ph.D., CEO & CSO, Medigene AGNeoantigens are an important class of highly specific target molecules for various immunotherapies. In transiting from identification of mutant peptides by NGS and prediction of binding to HLA allotypes, Medigene explores high throughput technologies to functionally verify that predicted neoantigens do in fact lead to T cell recognition. Our rapid methods bypass the need for patient cells, overcoming logistical restrictions for determining the true immunogenicity of predicted neoantigens.

12:00 pm Close of Personalized Cancer Vaccines and Neoantigen Targeted Therapies



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Quantitative Immune Profiling and Immune Monitoring

Biomarkers for Immuno-Oncology





Biomarkers



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Quantitative Immune Profiling and MonitoringImmunophenotyping and Immunosequencing for Immuno-Oncology Biomarker Discovery


MONDAY, AUGUST 28


IMMUNOPHENOTYPING: BIOMARKER DISCOVERY AND VALIDATION FOR IMMUNO-ONCOLOGY

8:25 Chairperson’s Opening RemarksMorganna Freeman, DO, FACP, Associate Director, Melanoma & Cutaneous Oncology Program, The Angeles Clinic and Research Institute

8:30 KEYNOTE PRESENTATION: The New Precision Medicine: The Role of Dynamic Tumor and Immune Sampling in ImmunotherapyMorganna Freeman, DO, FACP, Associate Director, Melanoma & Cutaneous Oncology Program, The Angeles Clinic and Research InstituteImmunotherapy has revolutionized the oncology treatment landscape, and as therapies evolve, there is a recognized need for biomarkers to inform the likelihood and duration of response. Radiologic assessments, i.e. RECIST, may be supplanted by biologically relevant markers in order to develop timely, cost-effective, and potentially personalized therapy. This presentation will review dynamic tumor and immune sampling as early markers of clinical response and their emerging role in clinical decision making.

9:00 Intersection of Host Factors and Novel Biomarkers for ImmunotherapyAdil Daud, M.D., Professor, Hematology/Oncology, University of California, San Francisco; Director, Melanoma Clinical Research, UCSF Helen Diller Family Comprehensive Cancer CenterT cell exhaustion is thought to be a critical mechanism for immune evasion by tumors. While PDL-1 immunohistochemistry provides a marker for the presence of tumor reactive T cells, we have developed a direct profiling method that involves extracting and profiling T cells directly from the tumor microenvironment. This flow-based method enables a dynamic picture of tumor T cell interaction. We

describe some of the applications of this method for predicting response to single agent or combination immunotherapy.

Sponsored by

9:30 Coffee Break

10:00 In situ Multiparametric Tumor Immunoprofiling for Translational Research in OncologyKurt Schalper, M.D., Ph.D., Assistant Professor, Pathology and Medicine (Medical Oncology), Yale School of MedicineDiverse studies have identified biomarkers associated with clinical benefit to immune checkpoint blockers. However, the clinical use of such tests is limited by their variable performance and restricted understanding of their biological significance. This presentation will cover the use of multiplexed analyses of tumor tissues to understand the tumor microenvironment, explore biological determinants of sensitivity/resistance to immunotherapy, and potential for use as a clinical biomarker.

10:30 Discovery and Integration of Omic, Immune Profiling, and Imaging Biomarkers for Cancer Immunotherapy DevelopmentXingfeng Bao, Ph.D., Senior Principal Scientist & Head, Immuno-Oncology, Andover Innovative Medicine Institute, EisaiBecause cancer immunotherapies modulate tumor progression through the dynamic and systemic human immune system, biomarker research for novel Immuno-oncology (IO) agents pose quite different challenges compared with those for cancer cell-targeting agents. Here, we present a case study of biomarker discovery and application in a Phase I clinical study of a novel immunomodulator by integrating Omic, immune profiling and imaging data.

11:00 Expression Profiling and Immunohistochemistry to Identify Cancer Immune LandscapesDarrell R. Borger, Ph.D., Director, Biomarker Laboratory, Massachusetts General Hospital Cancer CenterImmune checkpoint blockade has provided a pivotal advancement in cancer therapy. The ability to rationally direct the use of combination immune modulation or identify appropriate neoadjuvant/

adjuvant therapies requires a biomarker strategy. This talk will discuss ongoing efforts to combine multiplexed molecular approaches with histological approaches to further advance the application and advancement of cancer immunotherapy.

Sponsored by11:30 High Definition Multiplexing for Biomarker DiscoveryLouis Levy, Director, Corporate and Business Development, Ultivue Biomarker discovery in immuno-oncology requires the analysis of multiple protein markers (n>4) with their spatial relationships at an amenable throughput. The scrutiny of the tumor micro-environment demands whole-slide multiplexed images featuring immune and tumor cells. Ultivue’s InSituPlex platform fulfills this need with the data reproducibility relevant to CDx.



12:30 Session Break

IMMUNE MONITORING: BIOMARKERS OF RESPONSE TO IMMUNOTHERAPY

1:25 Chairperson’s RemarksSam Hanash, M.D., Ph.D., McCombs Institute for Cancer Early Detection and Treatment, MD Anderson Cancer Center

1:30 Cancer Immunotherapy Trials Network (CITN): Immune Monitoring Analysis of Multicenter TrialsSteven Fling, Ph.D., Staff Scientist, Vaccine & Infectious Disease, Fred Hutchinson Cancer Research Center; Director, Cancer Immunotherapy Trials Network Immune Monitoring LaboratoryThe CITN Central Lab provides three areas of expertise essential to immune monitoring of multi-center immunotherapy trials: i) standardized specimen collection protocols ensuring integrity for multiple specimen types, ii) validated correlative assays and



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Quantitative Immune Profiling and Monitoring MON-TUE | AUGUST 28-29

centralized specimen and data access to accelerate collaborative, data-driven trial design, iii) scientific guidance to support new protocols for iterative immunotherapy clinical initiatives. In-depth correlative immune monitoring results from two CITN clinical trials will be discussed.

2:00 Biomarkers for Cancer Immunotherapy Selection and Monitoring: Derived from Tissue, Blood, and Other BiospecimensGlen J. Weiss, M.D., MBA, Clinical Associate Professor, University of Arizona College of Medicine, PhoenixRecently, a number of new immunotherapies are available for clinical use for treating advanced cancer. A small portion of patients treated with monoclonal antibody immunotherapy do experience an impressive durable response. How are these therapies selected and efficacy monitored? This lecture will highlight some of the current data on biomarkers being used and evaluated for treatment selection and monitoring.

2:30 Profiling B Cell Subtypes and Autoantibodies for Immune MonitoringSam Hanash, M.D., Ph.D., McCombs Institute for Cancer Early Detection and Treatment, MD Anderson Cancer CenterThere is increasing evidence supporting a role for B cells in tumor immunology. The presence of tumor-infiltrating B lymphocytes has been linked to a favorable clinical outcome in many types of cancers. However, B cells represent a heterogeneous population with functionally distinct subsets, and the balance among subtypes impacts tumor development. Recent findings related to B cells and to the immune response in cancer will be presented.

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IMMUNOSEQUENCING AND MUTATIONAL LOAD: GENOMIC BIOMARKERS FOR IMMUNOTHERAPY PATIENT SELECTION

3:30 Applying Next-Generation Sequencing to Assess Immune-Mediated Drug HypersensitivityMasahide Yano, Ph.D., Research Scientist, Center for Drug Evaluation and Research, FDADrug hypersensitivity remains a major clinical problem especially due to its unpredictable outcome in preclinical standard toxicity tests, which often causes patients’ morbidity. A goal of this study is to understand immunological mechanisms that underlie severe adverse drug reactions. To achieve this, we employed next-generation sequencing technology to identify a defined repertoire of CD8+ T cell receptors

that recognize complexes of HLA/peptide/drug, and investigated their biological functions.

4:00 Development of Neoantigen Biomarkers–Are We There Yet?Saumya Pant, Ph.D., Associate Research Director, The Biocon Bristol-Myers Squibb Research & Development Center (BBRC), Bangalore, IndiaNeoantigen biomarkers have gained prominence in the age of genomics-driven personalized immuno-oncology therapies. This talk will discuss the current state of the field in the aspects of approaches and technologies utilized. The talk will close with a discussion of strategies of developing rigor for neoantigen BMx development and aspects that confound the assessment of neoantigen signatures.

4:30 End of Day

TUESDAY, AUGUST 29



PROFILING THE TUMOR MICROENVIRONMENT AND IMMUNE CELL INFILTRATION

8:25 Chairperson’s Opening RemarksTheresa Whiteside, Ph.D., Professor, Pathology, Immunology & Otolaryngology, University of Pittsburgh School of Medicine

8:30 Antigen-Presenting Tumor B Cells Impact the Phenotype of CD4 Tumor Infiltrating T Cells in Lung Cancer PatientsTullia Bruno, Ph.D., Research Assistant Professor, Immunology, University of PittsburghThe focus of immunotherapy has been on CD8 and CD4 tumor infiltrating lymphocytes (TILs); however, tumor infiltrating B cells (TIL-Bs) are understudied with no focus on their role as antigen presenting cells. We hypothesize that TIL-Bs help generate potent, long-term immune responses against cancer by presenting tumor antigens to CD4 TILs.

9:00 Major Histocompatibility Class II on Tumor Cells: Regulation, Functionality, and Predictive Role in PD-1/L1-Targeted Therapy OutcomesJustin Balko, Pharm.D., Ph.D., Assistant Professor, Medicine & Cancer Biology, Vanderbilt University School of Medicine; Leader of Molecular Oncology, Center for Cancer-Targeted Therapies, Vanderbilt Ingram Cancer Center

Antigen presentation is a key step in the generation of anti-tumor immunity. Although most normal cells express major histocompatibility class I (MHC-I) and present cellular antigens to CD8+ T lymphocytes, some solid tumors sporadically express MHC-II which is normally restricted to professional antigen presenting cells. The cellular pathways driving this phenomenon, the functionality of MHC-II on tumor cells, and their role in marking tumors responsive to PD-1-targeted immunotherapy will be discussed.

9:30 Late Breaking Presentation

10:00 P62-Encoding Plasmid as a Novel Class of Cancer ImmunotherapeuticAlexander Shneider, Ph.D., CEO/CSO, CureLabElenagen is a plasmid encoding p62/SQSTM1 eliciting antitumor immune response and mitigating chronic inflammation. In Phase I/IIa trial, no severe adverse events were observed. Four out of 6 ovarian cancer patients and 4 out of 8 breast cancer patients stopped the disease progression with a maximum of 32 weeks. All these patients achieved additional tumor stabilization for 12-28 weeks when treated with chemotherapy following Elenagen treatment, although they have previously failed chemotherapy. Therefore, Elenagen demonstrated good safety profile, antitumor activity, and ability to restore tumor sensitivity to chemotherapy.


LIQUID BIOPSY FOR IMMUNO-ONCOLOGY

11:15 Evaluating the Clinical Utility of Circulating Tumor Cells to Predict Response to Checkpoint Immune TherapyGayatri Premasekharan, Ph.D., Postdoctoral Scholar, Urology, University of California, San FranciscoCheckpoint immunotherapies including those targeting PD-1/PD-L1 have demonstrated clinical activity across a number of tumor types. While immunohistochemical staining for PD-1 and PD-L1 in tissue biopsies is modestly associated with response in some cancer types, better predictive biomarkers are needed. Analyzing circulating tumor cells and cell-free DNA may help fill this niche. This talk will review the current literature and discuss options for the future.



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Quantitative Immune Profiling and Monitoring MON-TUE | AUGUST 28-29

11:45 KEYNOTE PRESENTATION: Tumor-Derived Exosomes as Potential Biomarkers of Cancer Progression and Immune Dysfunction in CancerTheresa Whiteside, Ph.D., Professor, Pathology, Immunology & Otolaryngology, University of Pittsburgh School of MedicineWe present evidence that the molecular cargo of plasma-derived exosomes and their effects on immune cell subsets correlate with the disease activity and tumor stage in patients with head neck cancer (HNC). Also, in patients with acute myeloid leukemia (AML), plasma exosomes carrying TGF-β induce down-regulation of NK cell activity, and the exosome cargo and their suppressive activity correlate with response of patients to chemotherapy and with leukemia relapse. The data suggest that plasma-derived exosomes could be useful in the future as non-invasive biomarkers of immune dysfunction in cancer and thus of disease progression and outcome.

12:15 pm Close of Quantitative Immune Profiling and Immune Monitoring



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Biomarkers for Immuno-OncologyPredictive Biomarkers and Companion Diagnostics to Guide Cancer Immunotherapy


TUESDAY, AUGUST 29


PRECISION IMMUNO-ONCOLOGY: BIOMARKERS FOR PATIENT SELECTION

1:15 Chairperson’s Opening RemarksRobert Anders, M.D., Ph.D., Associate Professor, Pathology, Johns Hopkins University

1:20 KEYNOTE PRESENTATION: Biomarker Strategies for Precision Immune-OncologyDavid Kaufman, M.D., Ph.D., Executive Director, Translational Immunology & Oncology, Merck Research Laboratories

1:50 Atezolizumab in Metastatic Triple-Negative Breast Cancer: Clinical and Biomarker FindingsJakob Dupont, M.D., MA, Vice President, Global Head Breast & Gyn Cancer Development, Genentech, A Member of the Roche Group

Sponsored by2:20 Leveraging RNA-Seq for a Robust, Accurate Measure of HLA Calling for Endpoints in Clinical TrialsVictor Weigman, Ph.D., Director, Translational Genomics, Q2 Solutions, a Quintiles Quest Joint VentureIn this talk, EA Genomics will present information on new capabilities for Immune Oncology applications with RNA-Sequencing. Over the past year, EA has developed several applications for genomic testing across Immune Oncology Applications: infiltrating immune signatures, immune repertoire, mutational load, HLA identification and neoantigen discovery. We will also showcase HLAProfiler, a powerful algorithm which can make HLA calls from RNA-Seq data with high accuracy and discuss implications for doing so in FFPE specimens along with updates to substantially reducing input demands for RNA-Seq. Also discussed will be RNA-Seq as a confident measure for tumor immune response alongside routinely used clinical assays that is independent of application.

Sponsored by2:50 Overlap Between Genomic and Immunohistological Immunotherapy BiomarkersMaher Albitar, MD, SVP, Chief Medical Officer & Director, Research & Development, NeoGenomics Laboratories, Inc.




5:30 Dinner Short Course Registration*SC1: Bioinformatics for Immuno-Oncology andTranslational ResearchSC2: Microbiome in Immuno-Oncology*Separate registration required, please click here for details




PREDICTIVE BIOMARKERS IN IMMUNO-ONCOLOGY

8:25 Chairperson’s RemarksZhen Su, M.D., MBA, Vice President & Head of Global Medical Affairs – Oncology, EMD Serono

8:30 Are Biomarkers Still Necessary for the Era of Immuno-Oncology?Zhen Su, M.D., MBA, Vice President & Head of Global Medical Affairs – Oncology, EMD SeronoThe recent breakthroughs in cancer immunotherapy have reshaped our understanding of tumor biology, especially its microenvironment. Despite the new promises from the first wave of immune checkpoint blockage therapies, only a minority of cancer patients can truly benefit from its long-term anti-tumor effect. As the result of the speedy approval and broad biological impacts of immunotherapy, there

is a significant knowledge gap for the real-world adaptation of these new treatments and reliable biomarkers to guide safe and effective use of this new class of therapy in addition to the SOC.

9:00 Molecular Biomarkers of Response to KeytrudaAndrey Loboda, Ph.D., Director, Genetics and Pharmacogenomics, MerckThe talk will address molecular biomarkers of response to Pembrolizumab, including the role of tumor antigenicity, as measured by mutational load (ML) and T-cell inflamed microenvironment in predicting the response to Pembrolizumab. Data will be presented that prospectively validates the utility of both biomarkers as tumor type agnostic and orthogonal measures of response. These findings provide a biomarker framework for development of Pembrolizumab as a monotherapy and for characterizing responses to novel immunotherapy regimens.

9:30 Building a Better Biomarker for Immune Therapy: Lessons Learned from Colon CancerRobert Anders, M.D., Ph.D., Associate Professor, Pathology, Johns Hopkins UniversityCancer samples are predictive biomarkers that have long been used to select a patient’s therapy. Predictive biomarkers such as the expression of specific proteins or presence of DNA mutations in an oncogenic pathway have been used to select patients for targeted therapies. It is unlikely a single biomarker will be specific for selecting patients for immunotherapy. These concepts will be discussed in the setting of colorectal cancer.

Sponsored by10:00 Novel Biomarker Discovery Data Predicts Patient OutcomesSean Mackay, CEO, IsoPlexisThis presentation will explore the first high parameter, single-cell technology capable of defining subsets of powerful multi-functional, protein secreting cells that can determine and help predict patient response. The Precision Profiling platform captures the end function of thousands of single cells in a patient sample using to discover new information in immunotherapy and predictive biomarkers in CAR-T and TCR-T therapies.



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Biomarkers for Immuno-Oncology TUE-WED | AUGUST 29-30


11:15 KEYNOTE PRESENTATION: Strategy for Development of Predictive Biomarkers for ImmunotherapyIgnacio I. Wistuba, M.D., Department Chair, Department of Translational Molecular Pathology, Division of Pathology & Lab Medicine, The University of Texas MD Anderson Cancer CenterAs new immunotherapy strategies are being developed, particularly inhibition of immune checkpoints, there is an urgent need to develop predictive biomarkers for these therapies. We are increasing our ability to characterize the immune, molecular and genomic events associated with response or resistance to these treatments in tumor tissue, blood and other specimens of patients treated with these novel therapies. This approach will help to identify mechanisms of resistance to immunotherapy.

11:45 Predictive and Prognostic IO Biomarkers and Their Utility in Clinical TrialsJaclyn Neely, Ph.D., Senior Research Investigator II, Translational Medicine, IO Biomarker Lead, Bristol-Myers SquibbThe clinical benefit of immunotherapies is only demonstrated in a subset of patients. Single biomarkers are often not sufficient to predict response to immunotherapies. This presentation will review the importance of collecting predictive biomarker data, the associated challenges and opportunities, and how this data may inform the appropriate treatment of patients.

12:15 pm Multi-Omics Artificial Intelligence-Based Approaches for Identifying Immunotherapy RespondersOlivier Elemento, Ph.D., Cancer Systems Biology and Precision Medicine, Weill Cornell MedicineIn this talk I will present my group’s work on the (CLIA) whole-exome sequencing-based genomic test for precision cancer medicine and immunotherapy. A novel analytical pipeline that analyzes genomic profiles to unravel the immune landscape of tumors and integrates multi-omics features using machine learning to predict immunotherapy response will be described. Finally, high-throughput single cell genomics approaches to dissect the tumor microenvironment and unravel immune repertoires at the single cell resolution will be presented.


1:15 Session Break

COMPLEMENTARY AND COMPANION DIAGNOSTICS: PD-L1 AND BEYOND

1:55 Chairperson’s RemarksDeepti Aurora-Garg, Ph.D., Director, Companion Diagnostics, Merck

2:00 Development of a Complementary Diagnostic for TecentriqZachary Boyd, Ph.D., Companion Diagnostic Program Leader - Tecentriq (Atezolizumab), GenentechTecentriq (Atezolizumab) is the first anti-PD-L1 cancer immunotherapy to approved for the treatment of advanced non-small cell lung cancer (NSCLC) and urothelial carcinoma (UC). To assess the association of PD-L1 expression with therapeutic benefit, we partnered with Ventana Medical Systems to develop an immunohistochemistry assay to detect PD-L1 expression on specific cell types within the tumor microenvironment. The Ventana SP142 PD-L1 IHC was co-labeled with Tecentriq as a complementary diagnostic in NSCLC and UC. In this talk, I will review the underlying biomarker hypotheses that informed development of the SP142 assay and ultimate approval as a complementary diagnostic.

2:30 Evaluation of Multiple Biomarkers in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) in Response to Keytuda®

Deepti Aurora-Garg, Ph.D., Director, Companion Diagnostics, MerckHNSCC is generally associated with deficiencies of the immune system. Tumor-infiltrating lymphocytes activate interferon-mediated signaling that in turn induces expression of immune suppressive molecules (eg, PD-L1, PD-L2, IDO1) on cells in the tumor environment. Upregulation of immune suppressive molecules enables tumors to evade immune surveillance and progress. Keytruda, an anti-PD-1 antibody, blocks the interaction between PD-1 and its ligands. Hence in the Keytruda trials PD-L1, PD-L2 and gene expression signatures were evaluated to understand their utility in predicting response to Keytruda.

Sponsored by3:00 NGS Solutions Across the Oncology Drug Development Continuum: From Biomarker Discovery to IVDJohn K. Simmons, Ph.D., Director, Translational Science & Diagnostics, Personal Genome Diagnostics, Inc.At PGDx, we use NGS techniques in plasma and tissue to identify potential biomarkers of response and

resistance mechanisms that are critical to making informed treatment decisions. We offer CLIA-validated and custom assays for immuno-oncology and targeted panels in both tissue and plasma. Our panels can be used in clinical trials for both prospective enrollment and retrospective analysis. Ultimately, these panels can be clinically and analytically validated for FDA submission as in vitro diagnostics (IVDs).


BIOMARKERS OF RESPONSE AND RESISTANCE TO IMMUNOTHERAPY

4:15 Pathologic Response Patterns in Neoadjuvant Trials with ImmunotherapyJanis Taube, M.D., Associate Professor, Dermatology & Pathology, Johns Hopkins UniversityNeoadjuvant therapeutic response is graded by surgical pathology upon receipt of the resection specimen. Histopathologic features of response to immunotherapy in the neoadjuvant setting differ from features seen in response to neoadjuvant chemotherapy and targeted therapies. Those histopathologic features will be highlighted in the context of early clinical trials of immunotherapeutics in the neoadjuvant setting. These specimens also provide opportunity to study mechanisms of response and resistance to immunotherapy.


4:45 Understanding the Heterogeneity and Dynamics of Responses to Checkpoint Blockade in MelanomaAlexandre Reuben, Ph.D., Postdoctoral Fellow, Surgical Oncology, The University of Texas MD Anderson Cancer CenterThe success of immune checkpoint blockade has led to major efforts to identify biomarkers and mechanisms of response and resistance, specifically in melanoma. Here, we performed molecular (whole exome sequencing, gene expression profiling) and immune (immunohistochemistry, T cell receptor sequencing) profiling of longitudinal samples from patients treated with sequential CTLA-4 and PD-1 blockade. These studies shed light on biomarkers of response and mechanisms of resistance to immune checkpoint blockade.

5:15 Close of Biomarkers for Immuno-Oncology



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Advances in Vaccine Technologies Vaccine Adjuvants




Vaccines




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Advances in Vaccine TechnologiesDelivering Innovative Solutions to Improve Global Health


TUESDAY, AUGUST 29


INFLUENZA VACCINES

1:15 Chairperson’s RemarksMartha Alexander-Miller, Ph.D., Chair & Professor, Microbiology & Immunology, Wake Forest School of Medicine

1:20 Broadly Protective Influenza Vaccines - Protection against MismatchHarry Kleanthous, Ph.D., Associate Vice President, Head, Research (North America), Sanofi Pasteur

1:50 A Novel R848-Conjugated Inactivated Influenza Virus Vaccine Is Safe and Effective in NeonatesMartha Alexander-Miller, Ph.D., Chair & Professor, Microbiology & Immunology, Wake Forest School of MedicineInfluenza vaccines are not approved for use in infants under 6 months of age as a result of their limited effectiveness in this group. We have developed an R848 conjugated inactivated influenza vaccine that induces robust immunity and increased protection in a nonhuman primate neonate model. This opens the door to development of vaccines that are efficacious in young infants.

2:20 Results of a PhIa Study of M2SR Influenza Vaccine in Healthy AdultsPamuk Bilsel, Ph.D., CSO, FluGenFluGen’s M2SR (Single Replication) influenza vaccine candidate has demonstrated universal characteristics in animal models providing broad-spectrum, long-lasting cross-protection against multiple influenza subtypes (H3N2, H1N1 and H5N1). M2SR is administered intranasally to mimic a natural infection and induce broad-spectrum immunity including mucosal and cell-mediated responses. We will present the results of the first-in-man clinical study testing the safety and immunogenicity of M2SR in healthy adults.

2:50 Improving Influenza Vaccine EffectivenessAshesh Gandhi, PharmD, Regional Head, Seqirus




5:30 Dinner Short Course Registration*SC1: Bioinformatics for Immuno-Oncology andTranslational ResearchSC2: Microbiome in Immuno-Oncology*Separate registration required, please click here for details




NEXT-GENERATION VACCINES FOR INFECTIOUS DISEASE

8:25 Chairperson’s Opening RemarksPeter Pushko, Ph.D., President & CSO, Medigen

8:30 mRNA Vaccines, from Preclinical to ClinicalMike Watson, President, Valera, A Moderna Venture

9:00 Novel Vaccine Technologies against Emerging VirusesPeter Pushko, Ph.D., President & CSO, MedigenSafe and effective countermeasures are needed for emerging viruses. We developed two novel vaccine technologies to prepare experimental vaccines for avian influenza, alpha- and flaviviruses. The multi-subtype virus-like particle (VLP) approach was designed to display multiple subtypes of hemagglutinin to induce immunity to all influenza subtypes known to infect humans. In addition, we developed novel DNA-based vaccines, which use plasmid DNA to launch live-attenuated alpha- and flavivirus vaccines in vivo.

9:30 A Novel Alternative Approach to Develop a Safe Vaccine for ZikaFarshad Guirakhoo, Ph.D., CSO, GeoVax, Inc.Development of a safe and effective vaccine against Zika virus (ZIKV) is an urgent global health priority. GEO-ZM02 vaccine demonstrated 100% protection against lethal challenge after a single dose in a rigorous mouse model. Unlike other vaccines, which rely on ZIKV structural proteins, GEO-ZM02 is based on the NS1antigen that does not carry the risk of ADE and could potentially block transmission of ZIKV from humans back to its mosquito host.

10:00 Development of a Structurally-Stabilized Glycoprotein Vaccine for Lassa FeverRobert Garry, Ph.D., Professor & Director, Microbiology and Immunology, Tulane University School of Medicine


ADVANCES IN DNA VACCINE TECHNOLOGY

11:15 KEYNOTE PRESENTATION: DNA Immunization: From Vaccines to mAbsShan Lu, M.D., Ph.D., Professor, Medicine, University of Massachusetts Medical SchoolSince the discovery of DNA immunization technology in the early 1990s, significant progress has been made in both basic research and clinical applications of this novel approach. DNA vaccines have been included in a wide range of human and animal vaccine development programs. Experience has also been accumulated in using this approach to elicit unique and high quality monoclonal antibodies in both animal and humans.

11:45 DNA Vaccines as Treatment for Prostate CancerDouglas G. McNeel, M.D., Ph.D., Professor of Medicine & Director, Solid Tumor Immunology Research, University of Wisconsin Carbone Cancer CenterWe have been interested in DNA vaccines as T cell activating therapies for prostate cancer, with efforts to understand their mechanisms of action and tumor resistance. We present recent findings demonstrating upregulation of PD-1 and LAG3 with T cell activation, and translation of these findings to clinical trials



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Advances in Vaccine Technologies TUE-WED | AUGUST 29-30

using checkpoint inhibition with DNA vaccination to elicit objective responses in patients with advanced, metastatic prostate cancer.

12:15 pm Development of a New Generation of DNA Vaccines Using Syncon® TechnologyAnna Slager, Product Development Scientist, InovioBreaking tolerance remains a challenge for cancer vaccine development. Here we demonstrate that the new generation of DNA vaccines designed using SynCon® technology exhibited stronger ability to break tolerance and induced robust cellular immune responses.


1:15 Session Break

CANCER VACCINES

1:55 Chairperson’s RemarksDavid E. Anderson, Ph.D., CSO, VBI Vaccines

2:00 Harnessing the Immunogenicity of Foreign Viral CMV Antigens to Target Solid TumorsDavid E. Anderson, Ph.D., CSO, VBI VaccinesThe failure of many past cancer vaccines can be attributed at least in part to the inherently poor immunogenicity of the “self” tumor antigens they used. Cytomegalovirus (CMV) “foreign” viral antigens are expressed in over 90% of glioblastoma (GBM) and breast cancers. We are using enveloped virus-like particles (eVLPs) expressing the CMV pp65 and gB antigens to restimulate and redirect CD4+ and CD8+ T cell anti-tumor immunity. Plans are to file an IND for a Phase I/IIa trial with the FDA in H1 2017.

2:30 ATLAS™ Technology Identifies Unique Candidate Antigens for Potential Personalized Cancer VaccinesWendy Broom, Ph.D., Associate Director, Innovation and Automation, Genocea BiosciencesCurrent approaches to neoantigen prioritization involve deep sequencing of tumors, followed by selection of epitopes based on MHC class I focused prediction algorithms. ATLAS™ is a platform in which putative antigens are expressed as individual clones that can be processed by any subject’s antigen presenting cells and presented to autologous CD4+ or CD8+ T cells for measurement of recall responses. Data from recent neoantigen studies utilizing the ATLAS™ platform will be presented which reinforce the need to develop T cell immunotherapies with biologically relevant neoantigens.

3:00 DNA Vaccines for Therapeutic Treatment of CancerEmma Masteller, Ph.D., Senior Director, Immuno-Oncology R&D, Inovio PharmaceuticalsVaccines that generate robust and durable T cell immunity are needed as therapies for cancer. Inovio has developed a powerful technology platform to facilitate the discovery, development, and delivery of a new generation of DNA vaccines. These highly optimized synthetic vaccines are able to induce strong T cells responses. Even with the generation of tumor-specific T cells, the immunosuppression induced by the tumor still needs to be overcome. This talk will cover preclinical studies aimed at elucidating optimal immunotherapies to combine with DNA vaccines to eradicate cancer.


4:15 A Novel and Safe Viral Vector Platform for Developing Vaccines for Infectious Diseases and CancerFarshad Guirakhoo, Ph.D., CSO, GeoVax, Inc.GeoVax utilizes its recombinant Modified Vaccinia Ankara (MVA) vector to express foreign antigens on virus-like particles (VLPs) in the person being vaccinated. The MVA-VLP platform has several advantages including the ability to use single inoculations to achieve protection for hemorrhagic fever and Zika virus. The elicitation of both durable antibody and T cell responses has been shown for HIV in several clinical trials and the work on other infectious diseases and cancer is in progress.

SYSTEMS APPROACHESEmerging Investigator

4:45 A Systems Approach to Develop HIV VaccinesJishnu Das, Ph.D., Postdoctoral Associate, Lauffenburger Lab, Biological Engineering, MIT & Alter Lab, Ragon Institute of MGH, MIT & HarvardA major reason for the failure of HIV vaccines is the selection of immunogens based on antibody titer and neutralization, Fab domain functions that do not mechanistically drive protection. When neutralization fails to predict protection, a wide range of Fc effector functions drive protection and post-infection control. My talk will elucidate a systems serology approach that uses this ensemble of Ab functions to uncover mechanisms of action of HIV vaccines.

5:15 Close of Advances in Vaccine Technologies



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Vaccine AdjuvantsImproving Vaccine Response through Advanced Technologies


THURSDAY, AUGUST 31


UNDERSTANDING AND MODELING HUMAN IMMUNITY

8:25 Chairperson’s Opening Remarks

8:30 Modeling of Age-Specific Human Immunity in vitro for Discovery of Small Molecule AdjuvantsSimon van Haren, Ph.D., Research Fellow, Division of Infectious Diseases, Boston Children’s HospitalVaccine adjuvants may be most helpful for immunization of high risk populations, such as the very young and the elderly that express distinct immunity. The Precision Vaccines Program at Boston Children’s Hospital is leveraging age-specific human in vitro modeling, high throughput screening and systems biology to develop adjuvanted vaccine formulations tailored to such distinct and vulnerable populations.

9:00 Innate Immune Signaling, STING and Enhancing the Immune ResponseGlen N. Barber, Ph.D., Professor & Chair, Cell Biology, University of Miami Miller School of MedicineInnate immune STING-dependent signaling has been shown to play a key role in facilitating adaptive immune responses. Regulating STING activity exhibits significant promise in strategies designed to augment immune responses against microbial and malignant disease.

9:30 Cellular Effectors of the Humoral Immune ResponseDaniel Lingwood, Ph.D., Assistant Professor, Medicine, Harvard Medical SchoolWe describe how dendritic cells, without traditional MHCII-based antigen processing, regulate the initiation of the humoral response to subunit vaccines.


ADJUVANTS IN CANCER VACCINES

10:45 Vaccine Adjuvants in Cancer and Other Immunotherapy ApplicationsNikolai Petrovsky, MBBS, Ph.D., Chairman & Research Director, Vaxine; Professor, Flinders UniversityThis talk will address the benefits of new custom designed vaccine adjuvants for enhancing immunogenicity of vaccines against self-antigens or other poorly immunogenic antigens, including peptides and allergens. This has direct application to development of next-generation vaccines against cancer, allergy, autoimmunity and chronic degenerative diseases such as Alzheimer’s disease.

11:15 Archaeal Lipid Adjuvant Systems for Cancer Vaccine DevelopmentLakshmi Krishnan, Ph.D., Director & Program Leader, Vaccines and Immunotherapeutics, National Research Council, CanadaA novel class of archaeal lipid adjuvants, currently being developed as a third generation of highly simplified, cost-effective semi-synthetic glycolipid adjuvants that can be formulated with ease for cancer vaccine delivery, will be discussed.

11:45 Development of an Immunotherapeutic Vaccine for Curing Large Solid Tumors in MiceJoost Oppenheim, M.D., Senior Investigator, Cancer and Inflammation Program, Head, Cellular Immunology Section, National Cancer Institute, National Institutes of HealthWe are using a vaccine that aims to activate antitumor responses by synergistically stimulating tumor-infiltrating dendritic cells (DCs) with a combination of high-mobility group nucleosome binding protein 1 (HGMN1), a TLR4 agonist, and R848, a TLR7/8 ligand. We also aim to curtail tumor-associated immunosuppression by co-administering one of the checkpoint inhibitors (e.g. anti-CTLA4, anti-PD-L1, or low dose Cytoxan). Treatment of mice with this combination of immunotherapeutics, without giving any antigens, cures a variety of large (1 cm in diameter) tumors and results in long-term specific tumor immunity.

12:15 pm Cancer Immunotherapy Based on Cross-Priming Liposomes CAF09 - From Animal Model to Clinical TrialDennis Christensen, Ph.D., Head of Vaccine Adjuvant Research Group, Center for Vaccine Research, Statens Serum Institute, DenmarkWe will here present work that exploits a PRR combination strategy to obtain a liposome formulation that promotes strong CD8+ T-cell responses through efficient cross priming. Our lead candidate CAF09 is a liposomal formulation that exploits two ligands for TH17 responses and optimal cross priming of CD8 responses; a C-type lectin-receptor ligand (monomycolate) and a TLR3 agonist, Poly(I:C). This adjuvant induces very high CD8+ T cell responses against a range of polypeptide-based vaccines and has strong therapeutic efficacy in different cancer models in mice. The CAF09 formulation is now produced under GMP and will be used in a human clinical immunotherapy trial against prostate cancer in combination with the tumor associated antigen BCL-Xl.



1:15 Session Break

HIV VACCINES AND THE ROLE OF ADJUVANTS

2:25 Chairperson’s RemarksLakshmi Krishnan, Ph.D., Director & Program Leader, Vaccines and Immunotherapeutics, National Research Council, Canada

2:30 CD40L-Adjuvanted HIV VaccinesRama Rao Amara, Ph.D., Professor, Microbiology and Immunology, Emory UniversityStudies in rhesus macaques show adjuvanting DNA vaccine with CD40L significantly enhances the magnitude and functional quality of vaccine-induced cellular and humoral immunity, and protection against pathogenic simian immunodeficiency virus challenge.



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THU-FRI | AUGUST 31-SEPTEMBER 1Vaccine Adjuvants


3:00 Driving Humoral Responses against HIV Envelope via Multivalent Display of Env Trimers on Synthetic LiposomesTalar Tokatlian, Ph.D., Postdoctoral Research Associate, Irvine Lab, Massachusetts Institute of TechnologyMultivalent particulate presentation of HIV envelope trimers may contribute to the development of strong and durable humoral responses in immunization against HIV. To this end, we developed strategies to non-covalently and covalently anchor oriented envelope trimer constructs on the surfaces of synthetic liposomes. We have studied their physical properties and stability in vitro, their trafficking in vivo, and immunogenicity in mice and in non-human primates.


4:00 Panel Discussion with the Speakers: Next-Generation Vaccines and AdjuvantsModerator: Lakshmi Krishnan, Ph.D., Director & Program Leader, Vaccines and Immunotherapeutics, National Research Council, CanadaDiscussion topics include:• What is the future of personalized, precision

vaccines?• How have recent developments in understanding

the immune reponse accelerated vaccine research?• What new approaches may lead to promising HIV

vaccine candidates?• How will vaccine adjuvants advance the next

generation of cancer vaccines?

5:00 End of Day

6:00 Dinner Short Course Registration*SC4: CRISPR/Cas9 Applications inImmunotherapy*Separate registration required, please click here for details

FRIDAY, SEPTEMBER 1


RIG-I AGONISTS

8:25 Chairperson’s Opening RemarksGokul Swaminathan, Ph.D., Immuno-Biology Group, Merck Cambridge Exploratory Science Center, Merck & Co., Inc.

8:30 Selective RIG-I Agonists as Antivirals and Vaccine AdjuvantsAnna Marie Pyle, Ph.D., William Edward Gilbert Professor, Molecular, Cellular & Developmental Biology, Yale UniversityRIG-I agonists represent an important class of vaccine adjuvants. The well-developed structural and mechanistic characterization of RIG-I function has led to the design of small, synthetic RNA agonists that are being optimized for potency and bioavailability.

9:00 A Small-Molecule RIG-I Agonist Functions to Enhance Vaccine Protection against Influenza A Virus InfectionYueh-Ming Loo, Ph.D., Research Assistant Professor, Immunology, University of WashingtonWe have identified novel, small-molecule RIG-I agonists that bind to and activate RIG-I to induce IRF3 activation and drive innate immune responses to enhance adaptive immunity. These drug-like compounds confer enhanced protection of mice from high dose influenza A virus infection under conditions of suboptimal vaccine dose, showing that RIG-I agonists can serve as adjuvants to potentiate vaccine immunity.

NANOPARTICLES

9:30 Investigating Lipid Nanoparticle Formulations in the Context of Infectious Diseases and Immuno-OncologyGokul Swaminathan, Ph.D., Immuno-Biology Group, Merck Cambridge Exploratory Science Center, Merck & Co., Inc.Emerging evidence suggests that bioengineered nanoparticles can be used as immunomodulatory agents. We have previously reported the discovery of novel ionizable cationic lipid nanoparticle (LNPs) based formulations that are safe and efficacious in mice, guinea pigs and non-human primate models of vaccination. In this talk, I will discuss our findings on the mode-of-action of these LNPs and its potential usage in infectious diseases and immune-oncology applications.

10:00 Coffee Break

10:30 A Comparison of TLR3, TLR7/8, and TLR9 Adjuvants Encapsulated in Synthetic Vaccine Particles for Therapeutic Cancer VaccinesTakashi K. Kishimoto, Ph.D., CSO, Selecta Biosciences

Synthetic vaccine particles encapsulating antigens and various endosomal TLR agonists have been optimized to induce rapid and sustained induction of effector cytolytic T cells. These vaccines demonstrate a significant survival benefit when administered therapeutically in mice with palpable tumors, and also show considerable synergy with checkpoint inhibitors and cytotoxic drugs. We have confirmed the immunogenicity of these vaccines in a pilot study in non-human primates (NHP), comparing TLR3, TLR7/8 and TLR9 agonists for robust induction of antigen-specific T and B cells.

LYOPHILIZATION OF ADJUVANTED VACCINES

11:00 Feasibility of Freeze Drying of Oil-in-Water Emulsion AdjuvantsVidyashankara Iyer, Ph.D., Scientist, Formulation Sciences, MedImmuneOil-in-water emulsions are among the most widely investigated adjuvants. However, most emulsions cannot be readily frozen or lyophilized, due to the risk of phase separation, and may have a deleterious effect on protein antigen stability when stored long term as a liquid co-formulation. We will outline the development of a stable, lyophilized squalene emulsion adjuvant. Upon reconstitution, freeze-dried emulsion preparations showed a small increase in particle size and conferred immunogenicity in BALB/c mice similar in potency to freshly-prepared emulsion co-formulations in liquid form.

11:30 Overcoming the Cold-Chain Distribution Hurdle: Development of a Lyophilized Thermostable Single Vial Adjuvanted Vaccine against TuberculosisMichelle Chan Archer, Senior Formulations Specialist, Infectious Disease Research InstituteA key limiting factor to widespread vaccine accessibility in developing countries is the lack of reliable product transportation and continuous cold-chain storage. IDRI has developed a lyophilized thermostable tuberculosis vaccine that contains both antigen and adjuvant in a single vial. This prospect has advantages in 1) evading cold-chain dependence, 2) simplifying preparation by avoiding the need for bedside mixing of multiple vials, and 3) extending vaccine shelf lives.

12:00 pm Close of Vaccine Adjuvants



Cover


Short Courses






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Development

Translational IO

Therapy

Biomarkers

Vaccines

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Sheraton Boston Hotel39 Dalton StreetBoston, MA 02199(617) 236-2000

Discounted Room Rate: $229 s/dDiscount Cut-off Date: August 1, 2017

RESERVATIONS AND ADDITIONAL TRAVEL INFORMATION:Go to the travel page of Immuno-OncologySummit.com

Why Stay at the Sheraton Boston Hotel?

• Walking distance to some of Boston's best attractions, including Fenway Park, Museum of Fine Arts, Copley Square, Newbury Street, Boston Duck Tours, and much more.

• Just four miles from Boston's Logan International Airport

• Complimentary wireless internet access in guest rooms

• A "Make a Green Choice" and Pet Friendly Hotel

• Minutes from Boston's finest restaurants and shops



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Short Courses






Plenary Keynotes

Development

Translational IO

Therapy

Biomarkers

Vaccines

Training Seminar

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How to Register: [email protected] • P: 781.972.5400 or Toll-free in the U.S. 888.999.6288

Please use keycode IMX F when registering

ADDITIONAL REGISTRATION DETAILSEach registration includes all conference sessions, posters and exhibits, food functions, and access to the conference proceedings link.Handicapped Equal Access: In accordance with the ADA, Cambridge Healthtech Institute is pleased to arrange special accommodations for attendees with special needs. All requests for such assistance must be submitted in writing to CHI at least 30 days prior to the start of the meeting.To view our Substitutions/Cancellations Policy, go to healthtech.com/regdetailsVideo and or audio recording of any kind is prohibited onsite at all CHI events.

Reports designed to keep life science professionals informed of the salient trends in pharma technology, business, clinical development, and therapeutic disease markets InsightPharmaReports.com Contact Adriana Randall, [email protected], +1-781-972-5402.

Barnett is a recognized leader in clinical education, training, and reference guides for life science professionals involved in the drug development process. For more information, visit BarnettInternational.com.

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SHORT COURSES Academic, Government, Commercial Hospital-affiliatedOne short course $599 $299Two short courses $899 $549

August 29 | 6:30 - 9:00PM August 31 | 6:30 - 9:00PM

SC1: Bioinformatics for Immuno-Oncology and Translational Research SC3: Study Design and Statistical Data Analysis of Flow Cytometry Assays for Cancer Immunotherapy

SC2: Microbiome in Immuno-Oncology SC4: CRISPR/Cas9 Applications in Immunotherapy

CONFERENCE AND TRAINING SEMINAR PACKAGESPREMIUM PACKAGE (Includes access to all conferences and Training Seminar Monday – Friday. Excludes short courses.)Registration after July 28 $3,349 $1,799

STANDARD PACKAGE (Includes access to 2 conferences and/or Training Seminar. Excludes short courses.)Registration after July 28 $2,849 $1,399

BASIC PACKAGE (Includes access to 1 conference or Training Seminar. Excludes short courses.)Registration after July 28 $1,999 $1,049

Monday - Tuesday Tuesday - Wednesday Thursday - Friday

Development Immunomodulatory Antibodies Rational Combination Cancer Immunotherapy


Translational IO Training Seminar: Immunology for Drug Discovery Scientists


Emerging Immuno-Oncology Targets

Therapy Oncolytic Virus Immunotherapy Adoptive T Cell Therapy Personalized Cancer Vaccines

Biomarkers Quantitative Immune Profiling Biomarkers for Immuno-Oncology Personalized Cancer Vaccines

Vaccines Oncolytic Virus Immunotherapy Advances in Vaccine Technologies Vaccine Adjuvants

CONFERENCE DISCOUNTSPoster Submission: Poster abstracts are due by July 28, 2017. Once your registration has been fully processed, we will send an email containing a unique link allowing you to submit your poster abstract. If you do not receive your link within 5 business days, please contact [email protected]. * CHI reserves the right to publish your poster title and abstract in various marketing materials and products.Alumni Discount: Cambridge Healthtech Institute (CHI) appreciates your past participation at the Immuno-Oncology Summit. As a result of the great loyalty you have shown us, we are pleased to extend to you the exclusive opportunity to save an additional 20% off the registration rate. Please note: Our records must indicate you were an attendee of the Immuno-Oncology Summit in the past in order to qualify.Group Discounts are Available! Special rates are available for multiple attendees from the same organization. For more information on group discounts contact Catherine Almquist at 781-972-5447, [email protected]

If you are unable to attend but would like to purchase the Event Proceedings CD for $750 (+shipping), please visit Immuno-OncologySummit.com.



Cover


Short Courses






Plenary Keynotes

Development

Translational IO

Therapy

Biomarkers

Vaccines

Training Seminar

Faculty

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