senzagen ab - handelskammaren · senzagen ab 2030 – hållbar konsumtion och produktion i en...
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SenzaGen AB2030 – Hållbar konsumtion och produktion i en cirkulär ekonomi Miljötillståndsdagen 201830 januari 2018
Anki Malmborg Hager, VD
GARD – Säkrare tester för hållbar produktion
Den nya globala standarden för djurfria tester
• 120 000 – 145 000 kemikalier i världen
• 22 000 kemikalier är klassade som
ingredienser i kosmetika
• 1000-2000 nya kemikalier varje år
Kemikalier omger oss dagligen
Kemikalier kan påverka vår hälsa
Alla hälsopåverkande egenskaper måste dokumenteras
Lagstiftning tvingar till testning• REACH-förordningen(EG) nr 1907/2006Alla kemikalier måste testas
• CLP-förordningen(EG) nr 1272/2008Alla kemikalier måste klassas
• EMAEuropean Medicines Agency – det Europeiskaläkemedelsverket.
Kemikaliemarknaden• GLOBAL REGULATORY ENVIRONMENT FOR CHEMICAL USAGE
REACH-like regulations being considered. Current only requires minimum hazard assessment
CEPA 1999
REACH: Full data set requirement on chemicals
3 000
Japan Others NAFTA EU Asia Total
Chemical industry EUR bn5
2010 2020
Kosmetikamarknaden
Animal ban
Prohibitions are considered
Guidelines to use alternatives
20132015
2013
2014
2014
GLOBAL REGULATORY ENVIRONMENT FOR ANIMAL TESTING
2016 2017 2018 2019 2020 2021
Cosmetic industry EUR bn
301.1
Läkemedelsmarknaden
9.6%
0%
20%
40%
60%
80%
100%
Phase I to II Phase II to III Phase III toNDA/BLA
NDA/BLA tpoApproval
Phase I toapproval
Success rate and time line clinical drug development
0
500
1 000
1 500
1970's 1980's 1990's 2010
Clinical drug development EUR m
Preclinical Clinical
12.9 years
1 approvedchemical
Product development
Rule of thumb is that of 10 000 tested chemicals for a
new clinically testedpharmaceutical product, only
1 makes it to the final product
OVERVIEW DRUG DEVELOPMENT STATISTICS
EU 2013Israel 2013Indien 2013Delstater i Brasilien 2014Nya Zeeland 2015Australien 2016Sydkorea 2016Taiwan 2016
… och processer pågår i de flesta delar av världen ...
Förbud mot djurförsök vid tester av kosmetika
Från uppfinning till företag2005-2010EU program Sens-it-ive. Resultatet blev GARD, ett djurfritt hudallergitest.
2010SenzaGen AB grundades av professorerna Carl Borrebaeck och Malin Lindstedt.
2010 - 2011De första patentansökningarna skickades in.Industriella samarbeten.
2014SenzaGen AB spinns ut från Lunds Universitet, och börjar bygga organisationen.
2017Bolaget noteras på Nasdaq First NorthMarknadsvärde 575 MSEK17 anställdaDotterbolag i USA
Kemikalier måste testas och djurförsök förbjuds i allt fler länder och branscher
3
8
13
18
23
28
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
Global in vitro toxicology market 2012-2022 EUR bn14
Average BBC Mordor Intelligence Grand View Reserach
Stratistics MRC Markets and Markets Marketers Media
MARKET GROWTH EXPECTATIONS
12
GARD - DEN ENDA IN VITRO METOD SOM ANALYSERAR EN GENETISK SIGNATUR HOS CELLER SOM UTSATTS FÖR KEMIKALIERS PÅVERKAN
Analysmetoder som speglar verkligheten
• Mänskliga celler från immunförsvaret
• Mäter 200 gener relevanta för hudallergier
• 90% tillförlitlighet
GARD – ett djurfritt hudallergitest
1. Allergisk reaction (GARDskin)• Positiv• Negativ
2. Styrkan i reaktionen (GARDpotency)• 1A – kraftig allergen• 1B – mild allergen
15
GARD i praktiken
Senzagen’s patented test process
ExposureSelection Isolation Quantification Readout
A human cell line mimicking the human immune system is used as target for exposure of substances to be tested.
The cells are exposed to the substance to be tested.
Their genomic product (transcripts) are isolated for downstream quantification.
The gene transcripts are quantified using multiplex Nanostringtechnology.
The readout is processed using advanced computer algorithms to assess a chemical’s ability to induce an allergic reaction.
GARD TECHNOLOGY
GARD i jämförelse med andra testmetoder
Test method Company Test system Accuracy Markers Measures strenght
GARDTMHuman immune
cells 90% >200 ✔
DPRA Cell free 80% 1 ✘
hCLAT Human cells 75% 2 ✘
KeratinoSens Human cells 77% 1 ✘
LLNA (in vivo / animal testing) N.a. Mice 72% N/A ✔
Valid
erad
e av
OEC
D
GARD-testerna stöds av omfattande vetenskaplig dokumentation
‣ Forreryd A, Johansson H, Albrekt AS, Borrebaeck CA, Lindstedt M. Prediction of chemical Respiratory sensitizersusing GARD, a novel in vitro assay based on a genomicbiomarker signature. PLoS One. 2015 Mar 11;10(3)
‣ Forreryd A., Johansson H., Albrekt A.S., Lindstedt M. Evaluation of high throughput gene expression platforms usingGARD – an assay for prediction of skin sensitization based on a genomic biomarker signature. BMC Genomics, 2014.
‣ Johansson H., Rydnert F., Kuehnl J., Schepky A., BorrebaeckC.A.K., Lindstedt M. GARD in-house validation – A proof of concept. Tox Sci, 2014.
‣ Larsson K., Lindstedt M., Borrebaeck C.A.K. Functional and transcriptional profiling of MUTZ-3, a myeloid cell line actingas a model for dendritic cells
URVAL AV LEDANDE PUBLIKATIONER TIDSKRIFTER
GARDplattformGARDskinGARDpotencyGARDairGARDmixturesGARDproteinGARDxxx
AffärsmodellKontraktslaboratorier
Distributörer
Global kommersialisering
Country Company AgreementUnited States Burleson Research Technologies
IQ BioscienceEndev Laboratories
Collaboration agreementDistribution agreementDistribution agreement
United Kingdom XCellR8Charles River
Distribution agreementDistribution agreement
Germany Eurofins Collaboration agreement
South-Korea Woojung Distribution agreement
“Our customers include every major pharmaceutical and biotechnology company in the world, major academic institutions and government research centers”
SenzaGen offices
SenzaGen partner agreements
GARDskin validation update
BRT (US)
Eurofins(DE)
SenzaGen (SE)
Lead Laboratory
Transfer Phase Validation Phase I Validation Phase II
N = 28 blinded
compounds
N = 28 blinded
compounds
N = 28 blinded
compoundsN = 50
GARDskin GARDpotency
BRT (US)93.8%
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MÄNNISKORNA BAKOM
StyrelseCarl Borrebaeck / Chairman of the board
Professor Carl Borrebaeck founded BioInvent International AB, Alligator BioScience AB, and Immunovia AB. Received AkzoNobel’s science prize and the Royal Academy of Fine Arts Academy gold medal.
Director of CREATE Health Center for Translational Cancer Research, as well as former vice-principal at Lund University. He is a founding mentor for NOME (Nordic Mentor Network), chairman of the board at Immunovia AB and SenzaGen AB as well as a board member at Clinical Laserthermia Systems AB and CB Ocean Capital AB.
Ann Gidner / Member of the board
Ann Gidner has a MSc in Chemical Engineering, LTH in Sweden, ENSIGC in France, and an MBA from Lund University. Leading global positions within Cambrex Corporation and LanxessCorporation where she successfully built large international commercial organizations with strong sales development.
Former head of the life science division at Semcon Caran and CEO of Monocl AB. Currently, business development director at Albumedix A / S, responsible for international licensing of a technology platform for drug development in drug delivery.
Laura Chirica / Member of the board
Laura Chirica has a Bachelor degree in biotechnology from the University of Bucharest in Romania, a biochemistry degree from the MET University in Turkey and a PhD in medical biochemistry from Umeå University in Sweden.
Currently Chief Commercial Officer at Immunovia AB with responsibility for the company’s global commercialisation strategy. Has extensive experience in designing and implementing sales, marketing and commercialization strategies in pharmaceutical and medical technology companies.
Ian Kimber / Member of the board
Ian Kimber is Professor of Toxicology at the University of Manchester who has developed the LLNA (Local Lymph Node Assay) test method (animal testing). Former vice president of the MRC Physiological Medicine and Infection Board, chairman of the British Toxicology Society, and chairman of the British Board of the UK NC3Rs.
Received a number of awards incl. Smithkline Beecham Laboratory Animal Welfare Prize and the Society of Toxicology Immunotoxicology Career Achievement Award, amongst others.
Carl-Henric Nilsson / Member of the board
Carl-Henric Nilsson is technical director in Industrial Organization and University lecturer in business administration and has started and runs successful courses in collaboration between Lund University of Technology and Economics. He has also published many scientific articles and studies.
Management consultant and entrepreneur and has a wide network of industry contacts in Europe, China and the United States.
LedningAnki Malmborg Hager / CEO
CEO of SenzaGen since 2014. Holds an MSc in chemical engineering as well as a PhD in immunotechnology and a pharma MBA from Falconbury.
Board member of Immunovia and Diaprost. Authored 30 scientific articles and book chapters and has written several patents.
Anna Cherouvrier Hansson / CCO
Bachelor’s degree in business economics from Lund University, Master’s degree in business economics from ESC Reims.
Extensive business development experience within industry at Camurus, Invest in Skåne, Zitha Consulting AB.
Steve Smith / Intellectual property counsel
Patent Attorney at Potter Clarkson LLP.
Serves as an adviser to SenzaGen for intellectual property rights and management of the company's growing IP portfolio.
Marianne Olsson / CFO
CFO of SenzaGen since 2016.
25 years of experience as economist from previous position as administrative manager at the Institution of Immunotechnology at Lund University.
Sandra Reynoso / Director business development SenzaGen Inc
Bachelor's degree in molecular biology, San Jose University, USA. Philosophy PhD in immunology and MBA from UCLA, USA.
Experience of medical development. CEO and owner of LabVet BioPacific LCC. Prev. at Pacific Biodevelopment and Sialogen.
Henrik Appelgren / CSO
Bachelor's degree in biology and has a philosophy PhD in genetic toxicology at Stockholm University.
Previously OECD test program coordinator, toxicologist at Kemikalieinspektionen. Extensive experience in development and evaluation of test methods.
Maria Agemark / Laboratory & quality manager
Dr. Maria Agemark has been laboratory and quality manager since 2015.
Background in research of membrane proteins at the Department of Chemistry, Lund University, as well as in the development of antibodies at the Institution of Immunotechnology.
Brian Rogers / CEO SenzaGen Inc
PhD in toxicology, University of North Carolina, USA. MBA from UCLA, USA.
Founder/owner of Pacific BioDevelopment. Successfully assisted companies with pharmaceutical authorities approvals. Prev. at Genentech, Chevron Health and National Institute of Environmental Health Sciences.