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.
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
Phase 3 clinical trial in advanced or metastatic Non-Small Cell Lung Cancer (NSCLC)
Tedopi® is currently in a Phase 3 registration study, Atalante 1, in Europe and the U.S. The study is aimed at evaluating the benefits of Tedopi® as compared to current standard chemotherapies (docetaxel or pemetrexed, both approved in 2nd line treatment) in HLA-A2 positive patients diagnosed with stage IIIB (locally advanced) or IV (metastatic) NSCLC.
On June 23, 2017, the company decided to temporarily halt patient enrolment in the Phase 3 clinical trial while continuing treatment for patients with advanced and metastatic cancer already enrolled. The decision was based on an emerging benefit/risk balance of the experimental treatment. During the fourth quarter of 2017, a complementary review of more mature clinical data will be conducted and a decision will be made about the continuation of the trial. The trial may continue as originally designed or the enrolment criteria may be amended to enrol only certain patient sub-groups (View the press release).
Data from the Phase 2 clinical trial showed that Tedopi® was effective in treating NSCLC by increasing patients’ relative survival rate.
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.