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January 25, 2023 Bioscience

BioXcel says results “promising” for prostate cancer drug candidate

PHOTO | STEVE LASCHEVER BioXcel Therapeutics CEO Vimal Mehta
By Michelle Tuccitto Sullo

New Haven-based BioXcel Therapeutics Inc. announced this month that its drug candidate for an aggressive form of prostate cancer showed “promising” top-line results in a Phase 2 trial. 

The company has been evaluating the effectiveness of BXCL701, its investigational, oral innate immune activator, in combination with the drug Keytruda (pembrolizumab) in patients who have small cell neuroendocrine metastatic castration-resistant prostate cancer (SCNC).

The company has submitted its full data to the 2023 American Society of Clinical Oncology Genitourinary Cancers Symposium for a presentation in February.

Dr. Vincent J. O’Neill, who is chief research and development officer with OnkosXcel Therapeutics, a wholly-owned subsidiary of BioXcel, said of the latest results, “We are pleased that BXCL701 in combination with pembrolizumab has demonstrated an encouraging response rate in this difficult-to-treat cancer with no currently approved FDA therapies.”

In 2022, there were an estimated 268,500 new prostate cancer patients, with approximately 10,740 progressing to SCNC, according to the company, citing American Cancer Society statistics.

BioXcel uses artificial intelligence to develop medicines in the areas of neuroscience and immuno-oncology.

The Phase 2a trial has been evaluating the safety and efficacy of BXCL701 in combination with pembrolizumab in men with SCNC. The trial included 28 patients, who received BXCL701 twice daily on days 1 through 14 of a 21-day cycle plus pembrolizumab administered intravenously on day 1 and every subsequent 21 days. 

The U.S. Food & Drug Administration has granted orphan drug designation to BXCL701 for acute myelogenous leukemia, pancreatic cancer, stage IIb to IV melanoma, and soft tissue sarcoma.

Contact Michelle Tuccitto Sullo at msullo@newhavenbiz.com.

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