Transgene Receives Approval to Start a Phase I Trial of TG6050, a Novel IL-12-Armed Oncolytic Virus Given by Intravenous Administration

Transgene Receives Approval to Start a Phase I Trial of TG6050, a Novel IL-12-Armed Oncolytic Virus Given by Intravenous Administration

TG6050 is a proprietary oncolytic virus derived from Transgene’s Invir.IO™ platform encoding interleukin-12 (IL-12) and an anti-CTLA4 antibody.

The Phase I trial, named Delivir, will evaluate the intravenous (IV) administration of this novel multi-armed immunotherapy in patients
with non-small cell lung cancer.

Strasbourg, France, January 6, 2023, 7:30 a.m. CET – Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, today announces it 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 clinical trial of TG6050, a novel oncolytic virus (OV) that will be administered intravenously in patients with advanced non-small cell lung cancer (NSCLC).

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. A short video detailing the mechanism of action can be found here.

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.

Hedi Ben Brahim, CEO of Transgene commented: “TG6050 is an exciting new asset within  Transgene’s growing oncolytic virus pipeline, and further demonstrates the ability of our Invir.IO™ platform to generate highly targeted immuno-oncology drugs. These multi-armed drug candidates are expected to have significant advantages over existing therapies. Acting like a Trojan horse, they induce the production of potent therapies such as IL-12 directly in the tumor. The goal: to achieve high concentrations of these drugs only in the tumor, for improved efficacy and fewer side effects compared to systemic administration of these drugs. Intravenous administration addresses a broader range of patients with solid tumors who are not suitable for intratumoral administration. IV administration has the potential to improve the outcomes of patients with advanced lung cancer patients who are in great need of new treatment options.

This CTA approval is an important milestone for Transgene, and we look forward to the first patient being recruited and providing further updates on TG6050’s clinical development.”

The first patient is expected to be enrolled in this multicenter trial in the first half of 2023.