Tedopi® is OSE’s most advanced product, currently in Phase 3 in patients with non-small cell lung cancer (NSCLC) after immune checkpoint inhibitor failure. Tedopi® is also in Phase 2 status in pancreatic cancer, a trial sponsored by the GERCOR cooperative group in oncology.
Tedopi® is a proprietary combination of nine optimized neo-epitopes plus one epitope giving universal helper T cell response targeting T cell activation.
Tedopi® is a personalized treatment for HLA-A2+ patients, a key receptor for the cytotoxic T-immune response.
Tedopi® benefits from strong patent protection and has received orphan status in the U.S. for HLA-A2 positive patients in NSCLC. In Europe, the product benefits from a personalized medicine status in HLA-A2 positive patients.
Phase 1 and 2 trials demonstrated the ability of Tedopi® to restore the immune-surveillance of cancer cells in HLA-A2 positive responder patients while inducing early T-cell memory response.
Additionally, a Phase 2 trial conducted in patients suffering from NSCLC with a poor prognosis, showed both a better survival rate in the Tedopi® treated group, as well as a positive correlation between epitope response and survival.
ABOUT THE TEDOPI® CLINICAL PROGRAM
Tedopi® is currently under evaluation in two major cancer indications: in NSCLC with an ongoing Phase 3 trial and in pancreatic cancer with a Phase 2 to be initiated early 2019.
NSCLC: The Phase 3 trial, Atalante 1, is evaluating the benefit of Tedopi® in HLA-A2+ patients at invasive stage IIIB or metastatic stage IV, in 2nd or 3rd line treatment following failure of a checkpoint inhibitor, compared to current standard chemotherapy treatments. The primary endpoint is overall survival. This international trial is being conducted in the U.S., Europe and Israel in two steps:
– Enrollment of approximately 100 patients and a performance analysis of the survival data;
– Based on this analysis, the observed clinical benefit of Tedopi® will determine the registration strategy to be implemented in a second step.
Pancreatic cancer: OSE Immunotherapeutics is collaborating with the oncology cooperative group GERCOR, a network of 300 cancer centers in France dedicated to clinical trials in solid cancers, who sponsors a Phase 2 trial.
Pancreatic cancer has a very high unmet medical need. Tedopi® will be tested as a stand-alone therapy or in combination with a PD-1 inhibitor as maintenance therapy in patients presenting a locally advanced or metastatic pancreatic cancer stabilized after four months of standard chemotherapy.