On May 27, 2021 OSE Immunotherapeutics (Paris:OSE) (ISIN: FR0012127173; Mnemo: OSE) and the FoRT Foundation (Fondazione Ricerca Traslazionale) reported that the Italian Medicines Agency (AIFA) and the Italian Ethics Committee approved the initiation of a new Phase 2 clinical trial evaluating Tedopi in combination with Opdivo or chemotherapy as second-line treatment in patients with metastatic non-small cell lung cancer (NSCLC) (Press release, OSE Immunotherapeutics, MAY 27, 2021, View Source [SID1234580716]).

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This three-arm Phase 2 study will evaluate neo-epitope-based vaccine Tedopi in combination with Bristol Myers Squibb’s Opdivo (nivolumab), an immune checkpoint inhibitor, or Tedopi plus chemotherapy or chemotherapy alone as second-line treatment in HLA-A2 positive patients with metastatic NSCLC after first-line chemo-immunotherapy.

The clinical trial will be sponsored by the Italian oncology Foundation FoRT. It will be supported by Bristol Myers Squibb, which will provide Opdivo, and by OSE Immunotherapeutics, which will provide Tedopi for the study as well as a partial financial support.

Federico Cappuzzo, M.D., Ph.D., Director Medical Oncology at Cancer Institute Regina Elena, Roma, Italy, and Chief Investigator of the study, comments: "Checkpoint inhibitors are now often used in first-line settings in combination with chemotherapy. For patients who have disease progression after checkpoint inhibitors, the standard second-line option remains chemotherapy. In particular for NSCLC patients with disease progression, we need additional second-line combinations of immuno-therapeutic agents to provide these patients with new options. The trial will evaluate a new treatment strategy with the combination of therapeutic vaccine Tedopi which, by activating T lymphocytes, might efficiently optimize a checkpoint inhibitor or chemotherapy treatment."

Alexis Peyroles, Chief Executive Officer of OSE Immunotherapeutics, comments: "We are very pleased to collaborate with Dr Federico Cappuzzo and FoRT to evaluate Tedopi in combination with Opdivo in second-line treatment of NSCLC patients after chemo-immunotherapy. This additional development program of Tedopi in NSCLC will expand the product’s clinical data in this indication for a patient population who needs innovative treatment options. Tedopi was evaluated as monotherapy post-checkpoint failure in NSCLC and already demonstrated positive results for the Step-1 of its Phase 3 Atalante trial, as presented at the 2020 ESMO (Free ESMO Whitepaper) congress*."

* 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