Transgene SA and BioInvent International AB (publ) announced they have received regulatory approval in Belgium for a clinical trial application (CTA) for a Phase 1/2a study of the novel oncolytic Vaccinia virus BT-001.
BT-001 is a best-in-class oncolytic Vaccinia virus. It has been generated using Transgene's Invir.IO™ platform and its patented large-capacity VVcopTK-RR- oncolytic virus, which 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. Delivering the anti-CTLA4 antibody directly to the tumor microenvironment will allow a local therapeutic activity and will thus greatly increase the safety and tolerability profile of the monoclonal antibody by reducing systemic exposure. BT-001 is being co-developed through a 50/50 collaboration between BioInvent and Transgene.