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BioXcel Therapeutics Announces Expansion of Phase 2 Trial of BXCL701 in De Novo and Treatment-Emergent Small-Cell Neuroendocrine Prostate Cancer
Initial findings from Phase 1b/2 trial of BXCL701 in combination with KEYTRUDA met efficacy threshold to support expansion of existing cohort of de novo and
About this update from Bioxcel Therapeutics, Inc.
[{"type":"text","content":"Initial findings from Phase 1b/2 trial of BXCL701 in combination with KEYTRUDA met efficacy threshold to support expansion of existing cohort of de novo and treatment-emergent Small-Cell Neuroendocrine Prostate Cancer (SCNC) High unmet medical need with no FDA approved therapies for patients presenting with SCNC Data from the trial, including the expansion cohort, anticipated by Q1 2022 NEW HAVEN, Conn., Oct. 18, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop potentially transformative medicines in neuroscience and immuno-oncology, today announced that it has expanded its ongoing Phase 1b/2 trial of BXCL701, the Company's investigational, orally administered innate immune activator, in heavily pre-treated metastatic castration-resistant prostate cancer (mCRPC) patients with either de novo or treatment-emergent small-cell neuroendocrine carcinoma (SCNC). The Company’s decision to advance BXCL701 into the second stage of the Phase 2a efficacy portion of the study follows the achievement of the protocol-specified efficacy threshold for cohort expansion, meaning observation of three composite responses. “There is currently no standard of care for mCRPC patients presenting with the SCNC phenotype,” said Vincent J. O’Neill, M.D., Senior Vice President and Chief Medical Officer of BioXcel. “SCNC is a particularly rare and difficult to treat variation of mCRPC. The decision to expand the SCNC cohort builds upon positive interim safety and efficacy data from the adenocarcinoma cohort presented last month at ESMO and moves us into the next stage of the evaluation lifecycle. With three composite responses observed among ten evaluable patients, and what we believe is a manageable side effect profile, we continue to be encouraged by BCXL701’s potential to generate an immune response in ‘cold’ tumor types. We intend to continue recruitment of additional patients for our SCNC cohort, and we look forward to the further evaluation of BXCL701 in this mCRPC patient population, as well as in our adenocarcinoma cohort, which also continues enrollment.” The Phase 1b/2 trial is an open-label, multicenter study to evaluate the safety and efficacy of BXCL701 in combination with pembrolizumab for men with mCRPC presenting with either SC...