OSE Immunotherapeutics announces a collaboration agreement with GenDx (Eurobio Scientific Group) to develop and validate a companion diagnostic test (CDx) in preparation for the confirmatory pivotal Phase 3 clinical trial of Tedopi, a second-line cancer vaccine candidate in non-small cell lung cancer (NSCLC).

GenDx, one of the pioneering companies in the field of HLA typing, develops and markets innovative molecular diagnostics, particularly in the field of high-resolution HLA typing and associated molecular diagnostic tests.

Under this framework collaboration agreement, GenDx will develop and validate a unique companion diagnostic test (CDx), predictive of an immunological biomarker to identify patients carrying the HLA-A*02 (1) genotype biologically responsive to Tedopi® epitopes. This CDx test, based on a simple blood sample and Next-Generation Sequencing (NGS) technologies, will be used to recruit the patient population eligible for inclusion in the next pivotal phase 3 trial of Tedopi®. The aim of this study will be to confirm the efficacy and safety of Tedopi® in second-line treatment after failure of checkpoint inhibitors (CPIs) in HLA-A*02 positive NSCLC patients, in support of the product's registration in the U.S. and Europe.

Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments: "We are very pleased to have started this collaboration with GenDx, a leading company in high-resolution HLA typing. This companion diagnostic test is the first step in selecting eligible HLA-A*02-positive cancer patients, thereby accelerating the clinical development and regulatory registration of Tedopi® as an innovative precision medicine treatment.

Maarten Penning, Chief Executive Officer of GenDx, adds: "This project to develop a companion diagnostic test for HLA-A*02 brings together our regulatory expertise, the company being one of the first to obtain IVDR (2) certification, and our extensive knowledge of software and reagent development for accurate, high-resolution HLA typing using NGS. We are very pleased to initiate this strategic collaboration with OSE, our goal being to contribute to improving the quality of life and survival of patients'.

In June 2023, OSE Immunotherapeutics received non-dilutive funding of 1.5 million euros from Bpifrance - Direction Régionale de Nantes - under the 'Prêt Innovation R&D' program, aimed at supporting the development of this companion diagnostic test associated with the pivotal Phase 3 clinical trial of Tedopi® in second-line treatment of NSCLC. The next trial is planned for the United States and Europe.

(1) NSCLC accounts for 85% of all lung cancers, and the HLA-A*02 phenotype is found in around 45% of the population. Based on the selection of patients after failure of a checkpoint inhibitor, the population targeted by Tedopi® in second-line treatment is therefore considered rare, with a strong medical need for new options. Up to 100,000 patients a year could benefit from Tedopi® in the 7 major markets in the United States, Europe, China and Japan. Tedopi® has been granted orphan status in the U.S. and is considered precision medicine in Europe for HLA-A*02 positive patients.

(2) IVDR = In Vitro Diagnostic Regulation

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