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BioXcel Therapeutics Announces Initiation of a Phase 2 Study of BXCL701 in Combination with a PD-1 Inhibitor for Treatment Emergent Neuroendocrine Prostate Cancer
Completed the Phase 1b safety lead-in, identifying recommended Phase 2 dose of BXCL701 in combination with pembrolizumab (KEYTRUDA®) in advanced prostate
About this update from Bioxcel Therapeutics, Inc.
[{"type":"text","content":"Completed the Phase 1b safety lead-in, identifying recommended Phase 2 dose of BXCL701 in combination with pembrolizumab (KEYTRUDA®) in advanced prostate cancer\n Initial interim data readout expected in the fourth quarter of 2020 NEW HAVEN, Conn., April 28, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics (“BTI” or “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to identify and advance the next wave of medicines in neuroscience and immuno-oncology, today announced the initiation of the Phase 2 efficacy portion of the Phase 1b/2 trial of BXCL701 in combination with pembrolizumab (KEYTRUDA®) for treatment emergent Neuroendocrine Prostate Cancer (tNEPC). Initial interim data from this study is expected in the fourth quarter of 2020. Results from the Phase 1b safety assessment of BXCL701, an investigational oral innate immunity activator, indicated that a split dose totaling 0.6 mg per day is the recommended dose when used in combination with KEYTRUDA®, a PD-1 inhibitor. The 0.6 mg total daily dose has shown on-target side effects consistent with cytokine activation. Splitting the daily dose can be associated with an improved safety profile and will be used in the efficacy portion of the clinical program. “Identifying the recommended Phase 2 dose of BXCL701, in combination with KEYTRUDA®, is a critical step for our immuno-oncology program, as it allows us to evaluate the anti-tumor activity in patients with tNEPC and other cancer types,” commented Vincent J. O’Neill, M.D., Senior Vice President and Chief Medical Officer of BTI. “tNEPC is a rare and highly aggressive form of prostate cancer, the most common malignancy in men, with no current standard treatments. With the DPP8/9 target amplified in some tNEPC tumors, we believe BXCL701 has the potential to facilitate a strong adaptive immune response, making tumors more responsive to immunotherapies, including the PD-1 inhibitor pembrolizumab. We believe BXCL701 has potential to treat this subpopulation, and if successfully developed and approved, could fill the gap in prostate cancer treatment.” The Phase 1b/2 trial is an open-label, multicenter study to evaluate the safety and efficacy of BXCL701 administered orally and daily, combined with pembrolizumab (KEYTRUDA®), in men with tNEPC. With the initial assessment of sa...