BioXcel Therapeutics has received approval from the US Food and Drug Administration (FDA) for an investigational new drug (IND) application for BXCL701.

The approval has enabled BioXcel to conduct a Phase Ib/II trial to evaluate BXCL701, an immuno-oncology product candidate, in combination with pembrolizumab (keytruda) as a potential therapy for treatment-emergent neuroendocrine prostate cancer (tNEPC).

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Scheduled to begin in the last quarter of this year, the single arm, Simon 2-stage open-label trial aims to enrol up to 40 patients at several sites.

The trial’s objective is to assess the safety, pharmacokinetics and anti-tumour activity of the combination of BXCL701 and pembrolizumab in tNEPC patients.

“We believe that the combination of BXCL701 and pembrolizumab has the potential to meaningfully improve the lives of patients.”

Its efficacy goal is objective response rate, and data readouts from the trial are expected throughout the next year.

BioXcel Therapeutics senior vice-president and chief medical officer Dr Vincent O’Neill said: “We believe that the combination of BXCL701 and pembrolizumab has the potential to meaningfully improve the lives of patients with this highly aggressive, rare form of prostate cancer, and to succeed where current checkpoint inhibitor monotherapies have demonstrated limited clinical benefit.

“We have an obligation to tNEPC patients to find a viable treatment and look forward to evaluating the combination in this trial.”

tNEPC is a rare hormone-refractory expression of prostate cancer that occurs after treatment with androgen deprivation therapies, including zytiga and xtandi.

There is currently no treatment for this highly aggressive tumour, which affects around 20%-30% of patients treated with androgen inhibitors.