These 10 neo-epitopes generate a specific response from the T cytotoxic cells against the malignant cells, which express at least one of these tumorous antigens. The selected epitopes are chemically optimized and combined to avoid any phenomenon of immune tolerance. Tedopi® is a personalized treatment for HLA-A2+ patients, a key receptor for the cytotoxic T-immune response.
The goal is to stabilize the development of the disease and to extend patients’ lives.
Phase 3 clinical trial in advanced or metastatic Non-Small Cell Lung Cancer (NSCLC)
Data from the Phase 2 clinical trial showed that Tedopi® was effective in treating NSCLC by increasing patients’ relative survival rate.
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).
Tedopi® in NSCLC was granted Orphan Drug Designation by the U.S. Food and Drug Administration and is a Personalized Medicine in Europe in HLA-A2 positive patients.
OSE Immunotherapeutics Partners with Oncology Physician Network GERCOR to Conduct a Combination Phase 2 Trial of Tedopi® for Pancreatic Cancer
In September 2017, OSE Immunotherapeutics and GERCOR, an independent non-profit French network of cancer specialists, announced their agreement to study Tedopi® in locally advanced or metastatic pancreatic cancer. This is a Phase 2 trial of maintenance therapy with Tedopi® alone or in combination with a PD-1 checkpoint inhibitor versus Folfiri*, in patients with stable disease after four months of standard chemotherapy with Folforinox** (View the press release).
* Folfiri: chemotherapy combining folinic acid, fluorouracil and irinotecan
** Folfirinox: chemotherapy combining folinic acid, fluorouracil, irinotecan and oxaliplatin
FOLFIRINOX versus Gemcitabine for Metastatic Pancreatic Cancer; Conroy T, Desseigne F, Ychou M, Bouché O, Guimbaud R, Becouarn Y, et al. Folfirinox versus Gemcitabine for metastatic pancreatic cancer. N Engl J Med 2011;364:1817-25
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