Nantes, France - OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) today provides a regulatory update on the clinical development plan of Tedopi, an immunotherapy activating tumor specific T-cells, in phase 3 in monotherapy in advanced or metastatic non-small cell lung cancer (NSCLC) after checkpoint inhibitor failure (ICI).
Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments: 'We are pleased with the positive outcomes from the US Food & Drug Administration (FDA) Type C Meeting following the supportive European Medicines Agency (EMA) advice, as we are actively preparing a confirmatory phase 3 trial to support the regulatory registration of Tedopi . ...