BioXcel Reports Positive OS Results From Phase 2 Trial Of BXCL701 In Patients With SCNC

BioXcel Therapeutics, Inc. (BTAI), a biopharmaceutical company focused on neuroscience and immuno-oncology, announced Tuesday positive overall survival or OS data from its Phase 2 trial of BXCL701 in combination with KEYTRUDA (pembrolizumab) in patients with small cell neuroendocrine prostate cancer or SCNC.

In pre-market activity on Nasdaq, BioXcel shares were gaining around 6 percent to trade at $2.90.

Further, the company said it is continuing to actively evaluate strategic options for its unit OnkosXcel Therapeutics LLC, including potential financing, strategic partnership, or M&A. OnkosXcel was formed in 2022 to develop BXCL701, the company’s investigational oral innate immune activator.

The Phase 2 trial is an open-label, multicenter study to evaluate the safety and efficacy of BXCL701 in combination with pembrolizumab in men with SCNC.

The primary objective of the trial is a composite response rate defined as either objective response by RECIST 1.1 criteria and/or PSA50 and/or CTC count conversion. Secondary objectives include duration of response, progression-free survival, overall survival, and biomarker evaluation.

In the trial, evaluable patients with SCNC as of a data cutoff of September 6 showed a median OS of 13.6 months, and a 12-month survival rate of 56.5%.

Vincent O’Neill, Chief R&D Officer, OnkosXcel Therapeutics, a unit of BioXcel, said, “We believe our trial results are highly encouraging for patients with this disease and have potential implications for our evaluation of BXCL701 for the treatment of other high-grade neuroendocrine tumors, such as small cell lung cancer, where effective therapies are lacking. We intend to discuss these data with the FDA to help determine our next steps with clinical development.”

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