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Tedopi®

Tedopi®

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 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 specific 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 an ongoing Phase 2.

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.

More information on ClinicalTrials.gov

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 which is sponsoring a phase 2 clinical trial as part of PRODIGE intergroup.

The Phase 2 trial, named TEDOPaM, is supported by Bristol-Myers Squibb, which provides Opdivo® (nivolumab) for use in the study. OSE Immunotherapeutics provides Tedopi® and a partial financial support.

TEDOPaM study aims at evaluating Tedopi® as a maintenance therapy, alone or in combination with Opdivo® compared to Folfiri* alone, in HLA-A2 positive patients with stable disease after 4 months of standard chemotherapy with Folforinox, a combination chemotherapy with folinic acid, fluorouracil, irinotecan and oxaliplatin.