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.
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