OSE Pharma receives positive opinion from several European countries to start pivotal Phase 3 trial of Tedopi®

Regulatory News:

OSE Pharma SA (ISIN: FR0012127173; Mnemo: OSE), an immuno-oncology company developing a T-specific immunotherapy for late-stage cancer patients, announces that the regulatory authorities in 7 European countries have issued a positive opinion to initiate its pivotal Phase 3 clinical trial of Tedopi® for patients diagnosed with advanced non-small cell lung cancer (NSCLC).

OSE Pharma’s dossier received a positive opinion through the Voluntary Harmonisation Procedure (VHP) which allows a simultaneous and harmonised assessment by national competent authorities in Europe as a way to optimize the development strategy and review timelines to enter clinical phase. These approvals will allow the pivotal Phase 3 trial of Tedopi® to start by the end of 2015.

"This greenlight of 7 European regulatory authorities is a major step in the product development allowing to start the pivotal registration clinical trial of Tedopi® in lung cancer patients. We warmly thank all the pharmaceutical, clinical and regulatory team strongly involved in this process ", said Dominique Costantini, CEO of OSE Pharma.

The Phase 3 clinical trial, which will include 500 patients in Europe and the United States, is expected to be completed in 2018 provided that the recruitment of patients, their observed survival and the safety of the product meet the usual criteria for this kind of trials. The trial will focus on patients diagnosed with stage IIIB (advanced) or IV (metastatic) non-small cell lung cancer (NSCLC) after at least one first line therapy failure. All patients will express HLA-A2 receptor (representing 45% of NSCLC patients). It is a key receptor for the cytotoxic T-immune response and HLA-A2 patients are the responder Tedopi® population. Tedopi® will be compared to current standard chemotherapy (docetaxel or pemetrexed, both approved in second therapy line). The primary endpoint of this trial will be overall survival (the Phase 2 study demonstrated a long survival of patients, considering how advanced their pathology was).

ABOUT OSE PHARMA

OSE Pharma is a biotech company that designs and develops cancer immunotherapy treatments using its Memopi® technology, through "neo-epitopes” (small synthetic peptides chemically modified to increase the binding the HLA A2 or TCR receptors) which triggers a cytotoxic T-cell response and leads the immune system to destroy cancer cells. More than 10,000 epitopes were selected.

Its lead product Tedopi® (OSE-2101) combines 10 optimized "neo-epitopes” simultaneously acting against 5 tumor-associated antigens (TAAs). These 5 antigens have been selected because they are a factor of poor prognosis in several types of cancers. The 10 optimized "neo-epitopes” have been selected and modified to enhance their binding to HLA-A2 and TCR receptors, and trigger a stronger T-cell response. These strong cytotoxic T-cell responses lead the immune system to destroy tumor cells expressing HLA-A2 antigens and one of the targeted tumor antigens (TCR).

The most advanced clinical stage of Tedopi® is a pivotal Phase 3 study to be launched soon in Europe and in the U.S. in patients diagnosed with non-small cell lung cancer (NSCLC). It will target patients whose cells are expressing HLA-A2 antigens, a key receptor for the cytotoxic T-immune response that can be found in nearly 45% of patients with lung cancer. The objective of this pivotal study will be to evaluate the benefits of Tedopi® compared to current standard chemotherapy treatments (docetaxel or pemetrexed) in this patient population. The primary endpoint of this trial will be overall survival (the Phase 2 study demonstrated a long survival of patients, considering how advanced their pathology was).

Tedopi® can be developed in Phase 2 in combination with other immunotherapeutic products or targeted therapies. It is also considered for other oncology indications (ovary, colon, prostate, breast) for HLA-A2 positive patients.

OSE Pharma is listed on Euronext Paris (ISIN: FR0012127173; Mnémo: OSE).

For more information, please visit www.osepharma.com

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Disclaimer:

This press release may expressly or implicitly contain forward-looking statements relating to OSE Pharma and its activity. Although OSE Pharma’s management believes that the expectations reflected in these forward-looking statements are reasonable, investors are cautioned that such statements are related to known or unknown risks, uncertainties and other factors that could lead actual results, financial conditions, performance or achievements to differ materially from OSE Pharma’s results, financial conditions, performance or achievements expressed, projected or implied by such information and forward-looking statements.

Other than as required by applicable law (article 223-1 et seq of the General Regulation of the AMF), OSE Pharma issues this press release at the date hereof and does not undertake any obligation to update or revise any forward-looking information or statements.

These risks and uncertainties include among other things, the uncertainties inherent in future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives,

For a description of risks and uncertainties which could lead to discrepancies between actual results, financial condition, performance or achievements and those contained in the forward-looking statements, please refer to Chapter 4 "Risk Factors" of the company’s Documents de Base filed with the AMF under number I. 14-056 on September, 17th 2014 and Chapter 2 "Risk Factors related to the Offer" in the prospectus approved by the AMF under number 15-078 on 6th March 2015, which can be found on the websites of the AMF (www.amf-france.org) and of OSE Pharma (www.osepharma.com).

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