BioXcel Therapeutics files BXCL701 CTA with U.K. health authorities
BioXcel Therapeutics, or BTI, announced that it has filed a clinical trial application, or CTA, with the U.K. health authorities for its immuno-oncology asset, BXCL701, an orally-available small molecule immune-modulator with dual mechanisms of action, in combination with pembrolizumab, a checkpoint inhibitor, in tNEPC. BTI is a clinical-stage biopharmaceutical development company utilizing novel artificial intelligence approaches to identify the next wave of medicines across neuroscience and immuno-oncology. Following approval of the CTA, BTI plans to expand the Phase 1b/2 US study of BXCL701 and pembrolizumab in tNEPC to the U.K. Data from the open-label trial will support the ongoing global clinical development of BXCL701. Additionally, BioXcel Therapeutics is preparing to file an investigational new drug, or IND, application with the FDA for a clinical trial evaluating the triple combination of BXCL701, NKTR-214 and avelumab in the treatment of advanced pancreatic cancer.