BioXcel Therapeutics, Inc (NASDAQ: BTAI) shares rose after the company reported the FDA acceptance of IND for lead immuno-oncology candidate, BXCL701, for the treatment of emergent neuroendocrine prostate cancer.
The company, based in New Haven, Connecticut, says it plans to evaluate BXCL701 in combination with pembrolizumab (Keytruda®) as a potential therapy for treatment-emergent neuroendocrine prostate cancer, with the trial expected to initiate in the fourth quarter of 2018.
CEO Vimal Mehta declared, "The FDA approval of this IND and initiation of this trial provides an important validation of our AI-powered approach to drug development, which enables us to develop therapeutic candidates more quickly, at a lower cost and with a higher probability of success than with traditional drug development approaches."
BXCL701 is an orally-available systemic innate-immune activator with dual mechanisms of action. It has demonstrated single agent activity in melanoma, with an established safety profile from 700 healthy subjects and cancer patients.
Designed to stimulate both the innate and acquired immune systems, BXCL701 works by inhibiting dipeptidyl peptidase (DPP) 8/9 and blocking immune evasion by targeting Fibroblast Activation Protein
Preclinical combination data evaluating BXCL701, a checkpoint inhibitor and other immuno-oncology agents has demonstrated encouraging anti-tumor activity in multiple tumor types and formation of functional immunological memory. BXCL701’s primary mechanism of action has recently been highlighted in multiple peer reviewed journals, providing an important validation of the scientific rationale behind BXCL701.
BTAI is a clinical stage biopharmaceutical development company that utilizes novel artificial intelligence approaches to identify the next wave of medicines across neuroscience and immuno-oncology.
Shares in BTAI galloped 35 cents, or 6.4%, to $5.83.
