Selexis SA and OSE Immunotherapeutics Collaborate to Advance Development of Immunotherapies for Cancer and Autoimmune Diseases

Selexis SA, a pioneering life sciences company and a global leader in mammalian (suspension-adapted CHO-K1) cell line generation, and OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnémo: OSE), announced today the signing of two service agreements that provide OSE Immunotherapeutics with access to high performance research cell banks (RCBs) from the Selexis SUREtechnology Platform™.

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The agreements are designed to help OSE Immunotherapeutics advance two of its preclinical products based on immune activation and regulation. Effi-DEM is a new-generation checkpoint inhibitor that blocks the Signal Regulatory Protein-a (SIRP-alpha) receptor expressed by myeloid suppressor cells (MDSC) and tumor-associated macrophages (TAM). MDSC and TAM play a key role in tumor growth. By specifically targeting the SIRP-alpha receptor, Effi-DEM transforms suppressive cells into effector anti-tumor cells. Effi-7 is a humanized monoclonal antibody targeting the CD127 receptor (the alpha chain of the Interleukin 7 receptor (IL-7R)). It induces a powerful antagonist effect for better control of the pathogenic T lymphocytes involved in autoimmune diseases. The strategy of blocking the IL-7 has demonstrated efficacy in restoring the impaired immune balance in autoimmune diseases of the bowel in several preclinical models, such as ulcerative colitis.

Selexis’ proprietary SUREtechnology Platform facilitates the rapid, stable, and cost-effective production of virtually any recombinant protein and provides seamless integration of the biologics development continuum, spanning discovery to commercialization.

"Our SUREtechnology Platform plays a key role in helping companies, such as OSE Immunotherapeutics, use the body’s own immune system to fight disease and address immune disorders,” said Marco Bocci, PhD, DPharm, Selexis vice president, licensing and business development. "By targeting immune activation and regulation, OSE Immunotherapeutics has the potential through its investigational candidates to address significant unmet needs in cancer, autoimmune diseases and transplantation. We look forward to providing OSE Immunotherapeutics with robust cell lines to support the clinical progression of Effi-DEM and Effi-7.”

"Collaborations are a key component of our growth strategy, and we are pleased to begin a long-term relationship with Selexis to advance two of our promising immunotherapies into the next phases of development,” said Dominique Costantini, chief executive officer of OSE Immunotherapeutics. "With the assistance of our partners and innovative technologies, we are developing a new generation of first-in-class products that are optimized to better target key receptors of the activation or regulation of immune response.”

About OSE Immunotherapeutics

Our ambition is to become a world leader in activation and regulation immunotherapies: OSE Immunotherapeutics is a biotechnology company led by world-class immunologists and focused on the development of innovative immunotherapies of activation and regulation in immuno-oncology, autoimmune diseases and transplantation. The company has a balanced portfolio of first-in-class products with a diversified risk profile ranging from clinical Phase 3 registration trials to R&D:

• Tedopi®, a combination of 10 optimized neo-epitopes to induce specific T activation in immuno-oncology - currently in registration Phase 3 trial advanced NSCLC HLA A2+ patients EU /US - Orphan Status in the US - registration expected in 2019 - a Phase 2 with Tedopi® in combination with a checkpoint inhibitor in NSCLC is considered in 2017 - the product is also considered in other cancer indications.
• FR104, CD28-antagonist in immunotherapy - Phase 1 trial completed – for the treatment of autoimmune diseases and for use with transplantation - licensed to Janssen Biotech Inc. to pursue clinical development
• Effi-7, interleukin receptor 7 antagonist - in preclinical development for inflammatory bowel diseases and other autoimmune diseases
• Effi-DEM, new-generation checkpoint inhibitor targeting the SIRP-a receptor - in preclinical development for immuno-oncology
• R&D: candidates targeting new receptors in immuno-oncology

The portfolio’s blockbuster potential gives OSE Immunotherapeutics the ability to enter into global agreements at different stages of development with major pharmaceutical players.

Immunotherapy is a highly promising and growing market. By 2023 Immunotherapy of cancer could represent nearly 60 percent of treatments against less than 3 percent at present* and the projected market is estimated at $67 billion in 2018.**

There are more than 80 autoimmune diseases that represent a significant market including major players in the pharmaceutical industry with sales of towards $10 billion for the main products. The medical need is largely unmet and requires the provision of new innovative products involved in the regulation of the immune system. More information: http://ose-immuno.com

* Citi Research Equity
** BCC Research

About Selexis SA

Selexis SA is a pioneering life sciences company and a global leader in mammalian (suspension-adapted CHO-K1) cell line generation, providing unparalleled proprietary technology and the highly specialized expertise that is necessary to translate scientific innovation into life-saving medicines for patients. Selexis’ SUREtechnology Platform™ facilitates the rapid, stable, and cost-effective production of virtually any recombinant protein and provides seamless integration of the bioproduction continuum, spanning discovery to commercialization. With more than 95 partners worldwide, nearly 80 drug products in clinical manufacturing and two commercial products utilizing its cell lines, Selexis has a history of empowering scientists and biopharmaceutical companies around the world to realize the full potential of their research. More information is available at www.selexis.com.

Forward-looking statements

This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate.

These forward-looking statements include statements typically using conditional and containing verbs such as "expect”, "anticipate”, "believe”, "target”, "plan”, or "estimate”, their declensions and conjugations and words of similar import.

Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance.

This press release includes only summary information and should be read with the OSE Immunotherapeutics Reference Document filed with the AMF on 8 June 2016 under the number R.16-052, the consolidated financial statements and the management report for the fiscal year 2015, as well as the Merger Document registered with the AMF on 26 April 2016 under number E.16-026, all available on the OSE Immunotherapeutics’ website.

Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements.

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