»OSE Immunotherapeutics and the FoRT Foundation announce the start of a phase 2 study evaluating Tedopi® in combination with Opdivo® MyPharma Editions

Posted on Friday, May 28, 2021

OSE Immunotherapeutics and FoRT (Fondazione Ricerca Traslazionale) have announced the authorization of the Italian Drug Agency (Agenzia Italiana del Farmaco, AIFA) and the Ethics Committee to start a new phase 2 clinical trial evaluating Tedopi® in combination with Opdivo® or with second-line chemotherapy in patients with non-small cell metastatic lung cancer.

The trial will include 3 treatment arms and will evaluate Tedopi®, a neo-epitope-based vaccine, in combination with Opdivo® (nivolumab), the Bristol Myers Squibb immune inhibitor checkpoint, or Tedopi® in combination with chemotherapy versus chemotherapy alone as a second line of treatment in HLA-A2 positive patients with metastatic non-small cell lung cancer, after a first line of chemoimmunotherapy.

The clinical trial will be promoted by the Italian oncology foundation, FoRT. It will be supported by Bristol Myers Squibb which will provide Opdivo® (nivolumab) and by OSE Immunotherapeutics which will provide Tedopi® and provide financial support.

Dr Federico Cappuzzo, MD, Medical Director of Oncology at the Regina Elena Cancer Institute in Rome, and principal investigator of the study, comments: “Inhibitory checkpoints are now often used in conjunction with chemotherapy as a primary treatment. cancer line. In patients who progress after an inhibitory checkpoint, the standard second-line treatment remains chemotherapy. In non-small cell lung cancer, there is a particular need for new combinations of immunotherapies to be offered as a second line to these patients. This study will evaluate a new treatment strategy based on a combination with our therapeutic vaccine Tedopi® which, by activating T lymphocytes, could effectively optimize the effect of treatment by checkpoint inhibitor or by chemotherapy ”.

Alexis Peyroles, CEO of OSE Immunotherapeutics, adds: “We are very happy to collaborate with Dr Federico Cappuzzo and FoRT to evaluate Tedopi® in combination with Opdivo® as a second line of treatment for non-small cell lung cancer after failure. chemoimmunotherapy. This new Tedopi® development program will make it possible to complete the clinical data on Tedopi® in this indication to respond to patients awaiting innovative treatment options. Tedopi® has been evaluated as monotherapy in non-small cell lung cancer after failure of inhibitory checkpoints in a phase 3 trial, Atalante, whose positive stage 1 results were presented at the 2020 ESMO Congress * “.


* OSE Immunotherapeutics has shown positive results from step-1 of the phase 3 Atalante trial including a significant increase in overall survival in patients with non-small cell lung cancer after failure of a checkpoint inhibitor treatment (12-month survival rate in patients treated with Tedopi® versus standard treatment). Today, the Company intends to discuss with the regulatory health authorities (Food and Drug Administration and European Medicines Agency) to determine the best options to continue the development of Tedopi® and to maximize the positive data obtained in terms of benefit / risk ratio.

Source : OSE Immunotherapeutics



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