(CercleFinance.com) – OSE Immunotherapeutics announces a collaboration agreement with GenDx (Eurobio Scientific Group) to develop and validate a companion diagnostic test (CDx) as part of the preparation of the pivotal confirmatory phase 3 clinical trial of Tedopi , candidate cancer vaccine, as second line treatment 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 related 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 who are 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 study of Tedopi®. The objective of this study will be to confirm the effectiveness and safety of Tedopi® in second line treatment after failure of checkpoint inhibitors (CPI) in HLA-A*02 positive patients with NSCLC, to support product registration in the United States and Europe.
Nicolas Poirier, Managing Director 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 to select eligible HLA-A*02 positive cancer patients, and thus help accelerate the clinical development and regulatory registration of Tedopi® as an innovative precision medicine treatment. ‘.
Maarten Penning, Managing Director of GenDx, adds: “This project to develop a companion diagnostic test for HLA-A*02 brings together our regulatory expertise, with the company being one of the first to obtain IVDR certification (2), and our extensive knowledge of developing software and reagents for accurate, high-resolution HLA typing using NGS. We are very pleased to initiate this strategic collaboration with OSE, our objective 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 – Nantes Regional Directorate – as part of the ‘R&D Innovation Loan’ program, aimed at supporting the development of this associated companion diagnostic test in the pivotal phase 3 clinical trial of Tedopi® as second-line treatment in NSCLC. There are plans to conduct this next trial in the United States and Europe.
(1) NSCLC represents 85% of all lung cancers and the HLA-A*02 phenotype is found in approximately 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 per year could benefit from Tedopi® in the 7 major markets in the United States, Europe, China and Japan. Tedopi® has obtained orphan status in the United States and is considered precision medicine in Europe in HLA-A*02 positive patients.
(2) IVDR = In Vitro Diagnostic Regulation
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