Transgene has dosed the first patient in a Phase I trial evaluating TG6050 for recurrent metastatic advanced non-small cell lung cancer (NSCLC).

The trial (NCT05788926), called Delivir, will enroll up to 36 patients with advanced NSCLC who did not respond to previous therapy, such as immune checkpoint inhibitors. TG6050 will be administered intravenously (IV) in the trial.

TG6050 is an oncolytic virus from Transgene’s Invir.IO platform encoding interleukin-12 (IL-12) and an anti-CTLA4 antibody. Invir.IO viruses are based on Vaccinia virus and TG6050 has been engineered to trigger a powerful anti-tumour immune response. Selective targeting of tumour cells allows for higher intratumorally concentrations of therapeutic proteins and increases safety and tolerability.

IV administration expands the use of oncolytic viruses to a wider range of solid tumours, the French company said in a statement. Currently, oncolytic viruses play a limited role in oncology treatment as substantial evidence for efficacy lags behind other treatment options. In May 2023, AstraZeneca terminated its development collaboration with Transgene following “a strategic review of its pipeline.” Transgene have now regained global rights to the oncolytic virus drug candidate.

Completion of the Phase I trial is expected in the second half of 2023.

“Intravenous administration of TG6050 aims to 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,” said Dr. Maud Brandely, PhD, chief medical officer of Transgene.

“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.”