On March 15, 2021 OSE Immunotherapeutics (FR0012127173) and the French cooperative group ARCAGY-GINECO reported that the French National Agency for Medicines and Health Products Safety (ANSM) and the French Central Ethic Committee (CPP) approved the initiation of a new Phase 2 clinical trial evaluating Tedopi in patients with recurrent ovarian cancer (the TEDOVA trial) (Press release, OSE Immunotherapeutics, MAR 15, 2021, View Source [SID1234646983]). Tedopi will be evaluated alone and in combination with Merck’s Keytruda (pembrolizumab), an immune checkpoint inhibitor, as maintenance treatment in ovarian cancer patients after chemotherapy.

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The three arm TEDOVA study will evaluate neo-epitope-based vaccine Tedopi as a maintenance treatment, alone or in combination with anti-PD-1 Keytruda, versus the best supportive care in platinum-sensitive recurrent ovarian cancer patients with controlled disease after platinum-based chemotherapy.

The clinical trial is sponsored by the "Association de Recherche sur les CAncers dont GYnécologiques (ARCAGY-GINECO)" on behalf of GINECO, lead group for the TEDOVA trial of the European Network for Gynaecological Trial Groups (ENGOT). It will be supported in part by a research grant from the Investigator-Initiated Studies Program of MSD (Merck Sharp & Dohme Corp), a subsidiary of Merck & Co., Inc.", which will provide Keytruda (pembrolizumab), and by OSE Immunotherapeutics which will provide Tedopi for the study as well as partial financial support.

Alexis Peyroles, Chief Executive Officer of OSE Immunotherapeutics, comments: "This new clinical development program for Tedopi in ovarian cancer demonstrates the interest in exploring the potential of a PD-1-targeted checkpoint inhibitor combination strategy for combating oncology indications with significant unmet medical needs. We are very pleased to collaborate with the oncology group ARCAGY – GINECO to advance a new therapeutic pathway for patients suffering from a particularly aggressive cancer."

Dr Alexandra Leary, Chief Investigator of TEDOVA study from Gustave Roussy cancer center, adds: "Our patients with ovarian cancer do not respond to checkpoint inhibitors (ICI) alone because these tumors are ‘immune cold’. The objective of TEDOVA is to turn ovarian cancer into an ‘immune hot’ tumor using a combination of tumor associated neo-epitopes that have been optimized to break immunological selftolerance. TEDOVA is the first trial evaluating such an innovative approach in ovarian cancer and has received enthusiastic support from the international gynecological oncology community."

ABOUT OVARIAN CANCER
Worldwide, ovarian cancer is the seventh most common cancer and the eighth leading cause of cancer death in women. The five-year survival rate for ovarian cancer worldwide is 30-40%. In 2018, there were nearly 300,000 new cases diagnosed. Once the first relapse has occurred, ovarian cancer is managed as a chronic disease, requiring iterative lines of platinum-based chemotherapy. After 6 cycles, chemotherapy is stopped and one of the major priorities is to extend "chemotherapy-free" intervals for the patients by proposing maintenance strategies with targeted therapies (PARP inhibitors or bevacizumab). By the time patients with ovarian cancer present with first or second relapse, they will have received BOTH a PARP inhibitor and bevacizumab, thus patients progressing post-PARP inhibitors and bevacizumab represent an area of unmet medical need, they are offered chemotherapy alone with no maintenance strategy. The TEDOVA trial focuses on these women.