BOVNF - FDA approves BioInvent/Transgene's application for BT-001 in solid tumors

BioInvent International AB (BOVNF) and Transgene (TRGNF) announce that their Investigational New Drug ((IND)) application for BT-001 has been granted by the FDA.This IND will allow patients in U.S. to be enrolled into ongoing Phase 1/2a clinical trial of BT-001, which is evaluating BT-001 as a single agent and in combination with pembrolizumab (anti-PD-1 treatment).BT-001 is armed with both a differentiated Treg-depleting human recombinant anti-CTLA4 antibody and GM-CSF. The Phase 1 trial is divided into two parts. Part A will enroll up to 36 patients with metastatic/advanced solid tumors. Part B will explore the combination of intra-tumoral injections of BT-001 with the standard treatment regimen of pembrolizumab in 12 patients.The Phase 2a part of the trial will evaluate BT-001-based combination regimen in several patient cohorts with different tumor types.These expansion cohorts will offer the possibility of exploring the activity of this approach to treat other malignancies not traditionally addressed with

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FDA approves BioInvent/Transgene's application for BT-001 in solid tumors