OSE Immunotherapeutics and the FoRT Foundation Announce Initiation of a Phase 2 Clinical Trial Evaluating Tedopi in Combination with Opdivo (nivolumab) in Non-Small Cell Lung Cancer - Seite 2

* OSE Immunotherapeutics presented positive results of Step-1 of its Phase 3 Atalante 1 clinical trial, including a significant increase in overall survival in NSCLC patients after failure with checkpoint inhibitor (survival rate at 12 months in the patients treated with Tedopi versus standard of care). Today, OSE Immunotherapeutics intends to discuss with the regulatory health authorities, the U.S. Food and Drug Administration and the European Medicines Agency, to determine the best options to continue development of Tedopi and to maximize the data obtained in terms of risk / benefit ratio.

ABOUT FoRT

The Foundation for Translational Research (FoRT), founded by Dr. Federico Cappuzzo, is an Italian foundation developing and conducting clinical and translational research activities in the field of oncology. By promoting clinical and preclinical trials, FoRT aims at contributing to the development of innovative and personalized cancer treatments to improve the lives of patients.

ABOUT BRISTOL MYERS SQUIBB

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.

ABOUT OSE Immunotherapeutics

OSE Immunotherapeutics is an integrated biotechnology company focused on developing and partnering therapies to control the immune system for immuno-oncology and autoimmune diseases. The company’s immunology research and development platform is focused on three areas: T-cell-based vaccination, Immuno-Oncology (focus on myeloid targets), Auto-immunity & Inflammation. Its balanced first-in-class clinical and preclinical portfolio has a diversified risk profile:

Vaccine platform

- Tedopi (innovative combination of neoepitopes): the company’s most advanced product; positive results for Step-1 of the Phase 3 trial (Atalante 1) in Non-Small Cell Lung Cancer post checkpoint inhibitor failure.

In Phase 2 in pancreatic cancer (TEDOPaM, sponsor GERCOR)

In Phase 2 in ovary cancer (TEDOVA, sponsor ARCAGY-GINECO)

Due to the COVID-19 crisis, accrual of new patients in TEDOPaM should restart in 2021.

- CoVepiT: a prophylactic second-generation vaccine against COVID-19, developed using SARS-CoV-2 optimized epitopes against multi variants. Positive preclinical and human ex vivo results in August 2020. In clinical Phase 1.