MARCH 2014

Founded in 2009, Vaxeal, in partnership with leading international research institutes, is developing therapeutic vaccines in combination with immuno-modulatory drugs for the treatment of cancers and infectious diseases. Vaxeal’s initial programs have reached the pre-clinical stage in major disease segments, and are expected to enter into clinical trials in Europe in 2014 and 2015.

Strong progress has been made in the understanding of the multiple factors limiting immune response against tumors, and we have developed novel combination strategies using advanced technologies in order to optimize our vaccines. LSP-based cancer vaccines as well as advanced delivery systems focus on the optimization of T-cell cross-priming with the aim of generating a strong T-cell memory response against the tumor. Our combination with immuno-modulatory drugs addresses known issues related to tumor-mediated immunosuppression.

Vaxeal is targeting disease segments where high value markets are experiencing rapid growth and where major unmet patient needs exist.

Our scientists evaluate the best approaches in designing therapeutic vaccine combinations in order to ensure vaccine safety and efficacy, boost vaccine uptake, determine a safe dosage range, as well as minimize vaccine-related side effects. Our proprietary technology platforms allow us to develop relevant and predictive in vitro and in vivo efficacy and safety assays. They are prerequisites for our first-in-human clinical trials. We are developing an adapted pharmacovigilance system in order to anticipate potential long-term side effects. Our ultimate goal is also to improve patient access to new vaccines. The entire Vaxeal pipeline has been built according to these principles. Survivin, Midkine, Cyclin B1, and HCV therapeutic vaccines are the first products currently under development.

Vaxeal

Markets

Products

Advantage

Vaxeal’s clinical portfolio is the result of 15 years of research and is unique in the biopharmaceutical sector. It is protected by numerous patents and is at the heart of Vaxeal’s anti-cancer therapeutic vaccines platforms. Each product developed at Vaxeal addresses major unmet medical needs.

Vaxeal is developing game-changing treatments to meet future healthcare challenges

More than ever, patented treatments against unmet medical needs, such as cancer and infectious diseases, are becoming highly strategic for all biopharmaceutical companies. These large companies are increasingly relying on external R&D, primarily that of SMEs. These outsourced research programs now represent as much as 40% of their pipeline. Vaxeal is forecasting substantial licensing and M&A transactions in the coming years.

By targeting disease segments where high value markets are experiencing rapid growth, each product developed at Vaxeal has the potential to be a blockbuster with annual sales exceeding €5 billion. Additionally, these products should qualify for regulatory fast-track and special protocol assessment.

The innovative Vaxeal cancer vaccines will address a large spectrum of cancer patients, as they include three tumor antigens (Survivin, Midkine and Cyclin B1), which cover almost all solid tumors. The clinical results of Phase I/II trials should bring the promise of long-term survival when administered to cancer patients, and should lead to protective anti-tumor immunity with limited toxicity and adverse effects. Moreover, a better understanding of the immunological mechanisms of our vaccines will enable the more efficient development of vaccines beyond our current indications in the future.

Vaxeal has identified Phase IIa (Clinical Proof of Concept) as being the optimum exit point from a clinical trial perspective. This development phase, allowing the assessment of human safety and primary efficacy, offers the best risk-return profile while avoiding the surge in costs of Phases IIb or III.

Strategy

Exit

Risk  of  failure   Cost    (EUR  Millions)  

Milestones  Payment    

(EUR  Millions)  

Royal8es    

Phase  I   85%   1-­‐5   5-­‐7   <5%  

Phase  IIa   35%   3-­‐10   50-­‐100   10-­‐15%  

Phase  IIb   25%   50-­‐100   300-­‐400   High  

Phase  III   15%   200-­‐300   Very  high   Very  high  

Opportunity

Vaxeal focuses on developing therapeutic vaccines to meet the growing need for improved anti-cancer treatments

Vaxeal has also signed an exclusive patent agreement with the Finlay Institute and the University of Cambridge protecting an advanced new generation of immuno-potentiators. Vaxeal continues to expand, consolidate and update its intellectual property position.

Vaxeal and the Commissariat à l’Energie Atomique (CEA) have signed an exclusive worldwide license agreement protecting T cell epitopes of the tumor antigens Survivin, Midkine, Cyclin B1 and Hepatitis C.

CD4+ Survivin Epitopes and Uses Thereof   CEA* 2005

Immunogenic peptides derived from the Midkine protein, as an anticancer vaccine CEA* 2008

Mixture of peptides from Core and NS3 proteins of Hepatitis C virus and applications thereof CEA* 2002

Immunogenic peptides derived from the Cyclin B1 protein, as an anticancer vaccine CEA* 2013

Formulation and composition of survivin-based cancer vaccine Vaxeal 2014

Unique and innovative scientific research is at the heart of Vaxeal’s value proposition

IP Portfolio

* Exclusive License to Vaxeal

Vaxeal Development Pipeline

Products 2013 2014 2015 2016 2017

Survivin (1) Pre-­‐clinical  PoC  studies  

Phase  I/II  Phase  IIa  

                                                                                 

Cyclin B1 (3)

   

   

   

Midkine (2)

   

   

   

                                                                                 

Combo (1+2+3)

               

                   

   

Industry Highlights: At the end of 2012, the pipeline for therapeutic vaccines had grown to an estimated 400 products and was larger than that for prophylactic vaccines. The vaccines in development cover more than 70 different conditions but vaccines for cancer account for over half of the global pipeline (Ernst & Young, Beyond borders: global biotechnology report 2012). Vaxeal is at the forefront of this research with our novel strategy based on optimal combinations of its proprietary therapeutic vaccines with selected immuno-modulators.

Vaxeal’s optimized cancer vaccines address the issues of the multiple factors limiting immune response against tumors

Hepatitis C* gen.1-6                    

                   

* Partnered with China Medical City (CMC)

Vaxeal, in partnership with European healthcare stakeholders is an important contributor to the EU biotechnology sector. Vaxeal’s engagement aims to foster innovation and promote a favorable business and regulatory environment for European SMEs.

Synergies between Vaxeal and its partners will improve patient access to new vaccines

Memberships

Ahmed Bouzidi (Vaxeal Founder & CEO) is a member of the boards of both Vaccines Europe and European Biopharmaceutical Enterprises (EBE), where he is active in encouraging a more friendly business and regulatory environment for innovative SMEs.

Vaccines Europe represents major innovative vaccine research companies, which account for a large share of human vaccines used worldwide. Companies represented within Vaccines Europe are: Abbott Biologicals, J&J-Crucell, GlaxoSmithKline Vaccines, MedImmune, MSD, Novartis Vaccines, Pfizer Vaccines, Sanofi Pasteur, Sanofi Pasteur MSD, Takeda, and Vaxeal.

EBE represents major innovative biotech companies operating in Europe. Representative companies within EBE, and involved in the field of immuno-therapies are: Amgen, AstraZeneca, Baxter, Bayer, Merck, Roche and Sanofi amongst others.

Vaccines Europe An industry for healthy lives

Public-Private partnership is at the heart of Vaxeal’s product development strategy. Vaxeal plays a key bridging role in leading basic scientific discoveries emanating from academic research through clinical proof-of-concept.

Partners

Management Team

Dr Ahmed Bouzidi, PhD, MBA – CEO

•  Successful entrepreneur in Europe and China •  Founder & CEO of SEDAC (FR, US, China) •  Founder and CEO of Biophysiomics (Lux, China) •  Board Member of Vaccines Europe •  Board Member of EBE-Biopharma

Serge Grisard, MBA – EVP Corporate Development

•  20 years experience in healthcare product development, commercialization and PPPs

•  Global management at Siemens Medical, Pfizer, Astra-Zeneca, and a range of start-ups

Pr Giampietro Corradin, PhD – CTO

•  30 years of experience in vaccine development •  Worldwide expert in LSP-based vaccines •  Development of several vaccine candidates

Dr Jérôme Kerzerho, PhD – Director R&D

•  Expert in immunology •  Discovered the tumor antigens Midkine •  Identified new clinically relevant T cell epitopes in Survivin and

Midkine tumor antigens •  Previously head of a multidisciplinary team working on

pathogenesis of HIV and HCV disease

John Samuelson - CFO

•  20 years in global capital markets •  Early-stage private equity investments •  Project management in Russia, Middle East and Europe •  Advisor to UHNW clients

Vaxeal’s highly experienced executive team has an extensive track record in vaccine development and regulatory compliance. The Board also brings a wealth of diverse corporate and M&A experience.

Headquarters      Vaxeal  Holding  SA    Avenue  Paul  Cérésole  24  1800  Vevey  –  Switzerland  Phone:  +41  21  977  3000  Fax:  +41  21  922  1000  

International Offices Vaxeal Research SAS Genopoles Entreprises 4 Rue Pierre Fontaine 91058 Evry Cedex - France Phone: +33 1 60 87 89 31 Fax: +33 1 60 87 89 99

Vaxeal IP Management Sàrl Avenue de Tivoli 3 1700 Fribourg – Switzerland

Vaxeal China Inc. bioBay, 218 Xing Hu Road, A2 Building, Suite 214, Suzhou Industrial Park, Suzhou 215125 – China

For further information regarding Vaxeal products and solutions, please contact us at: info@vaxeal.net