Novel Treatment of Solid Tumors Clinical Study Opens for Americans
Sweden-based BioInvent International AB and Transgene announced that their Investigational New Drug application for BT-001 had been granted by the U.S. Food and Drug Administration. BT-001 is being co-developed through a 50/50 collaboration between BioInvent and Transgene.
This news enables patients in the USA to enroll in the ongoing Phase 1/2a clinical trial of this novel oncolytic virus BT-001.
The ongoing Phase 1/2a 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 1 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.
“We are pleased to receive IND approval for this Phase 1/2a clinical trial of BT-001, which is BioInvent’s fourth clinical program. This unique oncolytic virus has very exciting potential as it combines multiple mechanisms of action and anti-cancer properties, and we are looking forward to developing it further with our partners at Transgene,” said Martin Welschof, CEO of BioInvent, in a press release.
BT-001 is a novel oncolytic virus developed with Transgene’s Invir.IO™ platform. Invir.IO™’s viruses are based on the patented large capacity Vaccinia virus Copenhagen strain genetically modified with the double deletion TK-RR-. This optimization enhances the safety profile of the virus.
BT-001 is engineered to encode both a highly differentiated Treg depleting anti-CTLA4 antibody and the human GM-CSF cytokine.
The recombinant antibody recognizing human CTLA4 was generated by BioInvent’s proprietary n-CoDeR®/F.I.R.S.T™ platforms. The use of an oncolytic virus to deliver the anti-CTLA4 locally and selectively in the tumor microenvironment allows high intratumoral concentrations of both transgenes, eliciting a stronger and more effective antitumor response by reducing systemic exposure to a very low level.
BioInvent International AB (Nasdaq Stockholm: BINV) is a clinical-stage biotech company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapy, with currently three drug candidates in four ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors, respectively.