Transgene - First Patient Dosed in Phase I Trial Evaluating TG6050, a Novel IL-12-Armed Oncolytic Virus Administered Intravenously, in Non-Small Cell Lung Cancer

Transgene - First Patient Dosed in Phase I Trial Evaluating TG6050, a Novel IL-12-Armed Oncolytic Virus Administered Intravenously, in Non-Small Cell Lung Cancer

• TG6050 is an oncolytic virus derived from Transgene’s Invir.IO® platform encoding interleukin-12 (IL-12) and an anti-CTLA4 antibody, with the potential to trigger a powerful antitumor immune response.

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

• Intravenous administration extends the use of oncolytic viruses to a much wider range of solid tumors compared to intratumoral administration, broadening TG6050’s potential addressable markets.

Strasbourg, France, May 10, 2023, 8:00 a.m. CET – Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, announced that the first patient has been dosed in Delivir, a Phase I clinical trial evaluating TG6050. This multi-mechanism oncolytic immunotherapy is administered intravenously in patients with recurrent metastatic advanced non-small cell lung cancer (NSCLC).

TG6050 seeks to overcome tumor resistance by initiating an antitumor response through multiple mechanisms of action that include oncolysis, the induction of an immune response together with high intra-tumoral concentrations of IL-12 and anti-CTLA4 antibody.

The Delivir trial will enroll up to 36 patients with advanced NSCLC who have failed standard therapeutic options, including immune checkpoint inhibitors. The IV route is considered the most appropriate route of administration for this patient population with disseminated disease and multiple overt and occult metastases. Completion of the trial is expected in H2 2024.

The potential for IV administration of Transgene’s patented Invir.IO® platform has been seen in the data presented for TG6002. TG6050 will build on the safety profile of Transgene’s backbone while enhancing the therapeutic potential of its two highly immunogenic payloads – IL-12 and a full length anti-CTLA-4 antibody – while limiting exposure to their systemic toxicity.

“We are pleased to initiate this first-in-human trial of TG6050 administered intravenously in patients with recurrent/metastatic advanced non-small cell lung cancer in great need for effective new therapeutic options,” said Dr. Maud Brandely, MD, PhD, Chief Medical Officer of Transgene. “Intravenous administration of TG6050 aims at significantly enhance the therapeutic potential of this promising oncolytic virus as it allows a targeted approach to many internal cancer lesions and metastases inaccessible by intratumoral injection. With its multiple mechanisms of action – including oncolysis, the induction of an immune response together with high intra-tumoral concentrations of IL-12 and anti-CTLA4 antibody – and its ability to be administered intravenously, TG6050 has several competitive advantages. We look forward to progressing this trial and delivering clinical results for this promising new oncolytic virus.”

Efficacy and safety of TG6050 were demonstrated in preclinical and toxicology studies in non-human animal models. Initial data were presented at the American Association for Cancer Research (AACR) Annual Meeting, April 14 -19, 2023 and can be accessed here.