(Boursier.com) — OSE Immunotherapeutics SA announces a collaboration agreement with GenDx (Eurobio Scientific Group, a key player in the field of in vitro diagnostics) to develop and validate a companion diagnostic test (CDx) as part of the preparation of the pivotal confirmatory phase clinical trial 3 of Tedopi, a cancer vaccine candidate, for second-line treatment in non-small cell lung cancer (NSCLC).
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-A02 (1) genotype who are biologically responsive to Tedopi epitopes. This CDx test, based on a simple blood sample and next-generation sequencing technologies (NGS: Next-Generation Sequencing), will be used to recruit the patient population eligible for inclusion in the upcoming pivotal phase 3 study of Tedopi. The objective of this study will be to confirm the effectiveness and tolerance of Tedopi as a second line of treatment. after failure of checkpoint inhibitors (CPIs) in HLA-A02 positive NSCLC patients, to support product registration in the United States and Europe.
Remember that GenDx is one of the pioneering companies in the field of HLA typing. It develops and markets innovative molecular diagnostics, particularly in the field of high-resolution HLA typing and associated molecular diagnostic tests.
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