Transgene and BioInvent Receive IND Approval from the U.S. FDA for BT-001, a Novel Oncolytic Virus for the Treatment of Solid Tumors

Regulatory News:

Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and BioInvent International AB (“BioInvent”) (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, announce that their Investigational New Drug (IND) application for BT-001 has been granted by the U.S. Food and Drug Administration (FDA). This IND will allow patients in the U.S. to be enrolled into the ongoing Phase I/IIa clinical trial of this novel oncolytic virus BT-001. BT-001 is armed with both a differentiated Treg-depleting human recombinant anti-CTLA4 antibody and GM-CSF.

The ongoing Phase I/IIa (NCT04725331) study is a multicenter, open label, dose-escalation trial evaluating BT-001 as a single agent and in combination with pembrolizumab (anti-PD-1 treatment). The Phase I part of the trial has already been initiated in Europe, where it is enrolling patients in several countries.

BT-001 is expected to elicit a strong and effective antitumoral response by selectively targeting and modulating the tumor microenvironment. In addition, delivering the anti-CTLA4 antibody directly to the tumor aims to induce local Treg depletion and strong therapeutic activity. As a consequence, the safety and tolerability profile of the anti-CTLA4 antibody is expected to be greatly improved due to reduced systemic exposure.

BT-001 is being codeveloped through a 50/50 collaboration between BioInvent and Transgene.

Hedi Ben Brahim, Chairman and CEO of Transgene, said: “We have designed BT-001 to significantly improve treatment for patients with solid tumors by restoring their immune response against cancer. Its capacity to induce long-lasting antitumor immune responses and abscopal effects has been demonstrated in several tumor models. Patient accrual in the ongoing Phase I clinical trial is in line with our plan and highlight clinicians’ interest in this novel and promising immunotherapy approach. We are pleased to prepare the next step in its clinical development with this IND clearance which will allow us to enroll U.S. patients in this exciting clinical trial.”