Transgene and BioInvent receive approval from ANSM to proceed with Phase I/IIa trial of anti-CTLA4-armed oncolytic virus BT-001 in solid tumors

Transgene and BioInvent receive approval from ANSM to proceed with Phase I/IIa trial of anti-CTLA4-armed oncolytic virus BT-001 in solid tumors

Strasbourg, France – January 19, 2021 – 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 announced it has received approval from the French National Agency for the Safety of Medicines and Health Products (ANSM) to proceed with a Phase I/IIa study of the novel oncolytic Vaccinia virus BT-001. This announcement follows the approval received in December 2020 from the Belgian health authorities. The first patient is expected to be enrolled in this trial in the upcoming weeks.

BT-001 is AN oncolytic VIRUS GENERATED WITH TRANSGENE’S innovative INVIR.IO™ PLATFORM

BT-001 is based on the patented Invir.IO™ oncolytic virus (VVcopTK-RR-), and has been engineered to encode both a Treg-depleting human recombinant anti-CTLA4 antibody generated by BioInvent’s proprietary n-CoDeR®/F.I.R.S.T™ platforms, and the human GM-CSF cytokine. By selectively targeting the tumor microenvironment, BT-001 is expected to elicit a much stronger and more effective antitumoral response and greatly increase the safety and tolerability profile of the anti-CTLA4 antibody. BT-001 is being co-developed through a 50/50 collaboration between Transgene and BioInvent.

IN France, Four clinical centers WILL ENROLL PATIENTS

“The development of BT-001 is progressing well and we are pleased to start this clinical trial in France with patients being enrolled across the country in four reference clinical centers, and in other hospitals in Europe. BT-001 is a highly innovative oncolytic virus, that has been designed to achieve a strong anti-tumor response by combining multiple mechanisms of action. We would like to thank the investigators and the clinical teams for their support and look forward to treating the first patients with this first Invir.IO™ generated oncolytic virus candidate to enter clinical development” said Dr. Maud Brandely, MD, PhD, Chief Medical Officer of Transgene.

In France, the BT-001 Phase I/IIa trial will be conducted in four clinical centers: the Bergonié Institute (Bordeaux), the Gustave Roussy Institute (Paris area), the Centre Léon Bérard (Lyon) and the Hôpital Saint-Louis (Paris).

This international study will enroll up to 48 patients with metastatic/advanced solid tumors in its Phase I part followed by expansion cohorts in its Phase IIa part. The trial will evaluate the administration of BT-001 as a single agent and in combination with pembrolizumab, an anti-PD1.