OSE Immunotherapeutics Announces Temporary Pause of Patient Accrual While Continuing Treatment for Patients Already Enrolled In Phase 3 Clinical Trial of Tedopi® in Advanced Lung Cancer

NANTES, France I June 23, 2017 I OSE Immunotherapeutics SA (Paris:OSE) (ISIN: FR0012127173; Mnémo: OSE) today announced that following the recommendation by IDMC (independent experts) on the phase 3 clinical study, Atalante 1, which is evaluating Tedopi® for the treatment of non-small cell lung cancer, the Company is temporarily pausing patient accrual while continuing treatment for patients already enrolled in order to further assess the study’s current patient profile in relation to the potential benefit of Tedopi® with more mature data.

“The Company has decided to halt temporarily patient enrolment, but to continue treatment of patients already enrolled in this clinical trial, due to an emerging benefit/risk balance of the experimental treatment,” said Dominique Costantini, Chief Executive Officer of OSE Immunotherapeutics. “Patients eligible for inclusion in the Atalante 1 study are cancer patients at an advanced stage who have failed a first-line treatment with chemotherapy or failed second-line therapy with checkpoint inhibitors, and enter the trial at stage of disease progression. This cancer progression may be difficult to control for some patients in the near-term due to the generally longer-term activity observed with a combination of neoepitopes, which differs from chemotherapy’s generally near-term activity.”

Following further review of more patients’ data and additional information being available, a decision will be made for the trial continuation as such or possible amendment to include specific sub-groups of patients.

The expected safety profile was observed in both treatment groups. The safety profile observed in the experimental treatment group is consistent with the one observed in the previous clinical trials of Tedopi®.

“While further data analysis occurs here, we remain focused on advancing our other promising product candidates in the Company’s robust development pipeline,” continued Dr. Costantini.

ABOUT OSE IMMUNOTHERAPEUTICS

Our ambition is to become a world leader in activation and regulation immunotherapies

OSE Immunotherapeutics is a biotechnology company focused on the development of innovative immunotherapies for immune activation and regulation in the fields of immuno-oncology, auto-immune 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:

In immuno-oncology:

  • 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 - A Phase 2 with Tedopi® in combination with a checkpoint inhibitor in NSCLC is considered.
  • OSE-172 (Effi-DEM), new generation checkpoint inhibitor targeting the SIRP-α receptor - In preclinical development for several cancer models.
  • OSE-703 (Effi-3), cytotoxicmonoclonal antibody against the alpha chain of IL-7R - Under a multi-year strategic research collaboration with Memorial Sloan Kettering Cancer Center, New York

In auto-immune diseases and transplantation:

  • FR104, CD28-antagonist in immunotherapy - Phase 1 trial completed –For the treatment ofautoimmune diseases and for use with transplantation - Licensed to Janssen Biotech Inc. to pursue clinical development.
  • OSE-127 (Effi-7), interleukin receptor-7 antagonist - In preclinical development for inflammatory bowel diseasesand other autoimmune diseases.License option agreement with Servier for the development and commercialization.

The portfolio’s blockbuster potential gives OSE Immunotherapeutics the ability to enter 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% of treatments against less than 3% 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 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.

SOURCE: OSE Immunotherapeutics

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