Transgene announced it has received clinical trial application approval from the French National Agency for the Safety of Medicines and Health Products (ANSM) to proceed with a Phase I clinical trial of TG6050, anovel oncolytic virus that will be administered intravenouslyin patients with advanced non-small cell lung cancer. TG6050 has been generated using Transgene's patented Invir.IO™ platform. It has been engineered to express human IL-12, a cytokine that triggers a powerful antitumor immune response, and a full length anti-CTLA4 antibody.

By selectively targeting tumor cells and expressing IL-12 and the anti-CTLA4 antibody in the tumor microenvironment, TG6050 is expected to elicit a powerful and multi-pronged antitumor response. TG6050 has been designed to be administered intravenously, a route of administration that has been demonstrated to be safe and feasible with an Invir.IO™ based OV. Intravenous administration will significantly enhance the therapeutic and market potential of this OV as it allows a more targeted approach to many internal cancer lesions and metastases inaccessible by intratumoral injection.

Intratumoral injection, where the drug is injected directly into the tumor, is currently the only approved route of administration for an oncolytic virus. IV administration would represent a significant advantage. The Delivir trial will enroll up to 36 patients with advanced NSCLC who have failed standard therapeutic options, including immune checkpoint inhibitors (ICIs).

TG6050 is expected to overcome tumor resistance by the initiation of an antitumor response through multiple mechanisms of action that include oncolysis, the induction of an immune response and high intra-tumoral concentrations of IL-12 and anti-CTLA4 antibody. The IV route is considered the most appropriate route of administration for this patient population with disseminated disease and multiple overt and occult metastases.