Transgene SA has received clinical trial application (CTA) approval from the French National Agency for the Safety of Medicines and Health Products (ANSM) to proceed with a phase I trial of TG-6050, a novel oncolytic virus (OV) for intravenous administration in patients with advanced non-small-cell lung cancer (NSCLC). Enrollment is expected to open in the first half of this year.
Transgene SA is quitting development of one of its lead therapeutic vaccines after a combination of the candidate, TG-4010, with chemotherapy and Opdivo missed its primary endpoint in a phase II trial evaluating the combination as a first-line treatment for certain advanced non-squamous non-small-cell lung cancers.