Optimization of neo-epitopes is based on the double detection of HLA-A2 (Major Histocompatibility Complex molecule or MHC) and TCR receptors. The two families of epitopes are then combined (those strongly bound to HLA-A2 and those strongly bound to TCR receptors) for an increased cytotoxic T response and for an activation of immune response.

Main references to Tedopi® and recent treatment options in lung cancer

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Tedopi Phase 3

Atalante 1, an international Phase 3 trial currently ongoing

The Tedopi® Phase 3 trial, Atalante 1, is evaluating the benefit of Tedopi® in HLA-A2 positive patients with NSCLC at invasive stage IIIB or metastatic stage IV, in 2nd or 3rd line treatment following failure of a checkpoint inhibitor. The primary endpoint of the trial is overall survival.

In June 2017, following the recommendation by IDMC (independent experts), the Company was temporarily pausing patient accrual in the trial while continuing treatment for patients already enrolled in order to further assess the study’s current patient profile in relation to the potential benefit of Tedopi® with more mature data (view the press release).

Following the IDMC’s recommendation, it was decided that accrual of the Tedopi® Phase 3 trial in NSCLC could resume with a specified new recruitment strategy focused on a subgroup of patients who have failed a previous treatment with PD-1/PD-L1 immune checkpoint inhibitors, after approval of the competent authorities (view the press release). During the first quarter of 2018, the approvals to resume patient accrual in the trial have been granted in the United States (view the press release) and in Europe (view the press release) by the competent authorities. Moreover, Phase 3 Trial received approval to be initiated in Israel (view the press release).

Atalante 1 is being conducted internationally by a steering committee co-chaired by two clinical experts specializing in lung cancer treatments ; in Europe, by Dr. Benjamin Besse, Head of the Thoracic Pathology Committee at the Institut Gustave Roussy (Villejuif), and ; in the United States by Giuseppe Giaconne, Professor of Oncology, Medicine and Pharmacology at the Georgetown Lombardi Comprehensive Cancer Center in Washington.