On April 1, 2019 BioXcel Therapeutics, Inc. ("BTI" or the "Company") (BTAI) reported its preclinical data demonstrating potential for combining the Company’s BXCL701, an oral immunomodulator, and an OX40 agonist antibody as a possible combination therapy for certain solid tumors at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, BioXcel Therapeutics, APR 1, 2019, View Source [SID1234534936]). This year’s meeting is being held from March 29 to April 3, 2019 in Atlanta, Georgia. BTI is a clinical stage biopharmaceutical development company utilizing novel artificial intelligence to identify the next wave of medicines across neuroscience and immuno-oncology.

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Results from this preclinical study demonstrate that BXCL701, a dipeptidyl peptidase (DPP) and fibroblast activation protein (FAP) inhibitor, in combination with an anti-OX40 antibody resulted in synergistic anti-cancer activity and a statistically significant improvement in median survival compared to vehicle, as well as BXCL701 or the OX40 agonist alone. These results support the Company’s belief that the combination of BXCL701 and an OX40 agonist represents a new potential treatment approach against multiple cancer types, and provide rationale for a clinical efficacy study of the combination therapy. There are currently multiple OX40 agonists in various stages of clinical development.

Dr. Vincent J. O’Neill, Chief Medical Officer of BTI, commented, "We are pleased to report the findings from this study, which support the therapeutic rationale for combining BXCL701 with an OX40 agonist. This combination achieved a significant increase in anti-cancer activity in tumor models, as compared to control. These results further validate BXCL701 as a potentially versatile and effective immuno-oncology agent, due to its ability to stimulate both innate and adaptive immunity. Based on these results, we plan to explore further studies to enhance our understanding of this particular therapeutic approach and its potential in a clinical setting."

Prior studies have shown that BXCL701 inhibits tumor growth and up-regulates immuno-stimulatory cytokines as well as tumor infiltrating immune cells by targeting DPP 8/9 and FAP. Treatment with BXCL701 induces pyroptosis in macrophages, and results in the production of several pro-inflammatory factors important for a robust, anti-tumor adaptive immune response mediated by T-cells.

Full details of the accepted AACR (Free AACR Whitepaper) late breaking poster presentation are below:

Abstract #077 / Poster #22: Dipeptidyl Peptidase Inhibitor BXCL701 synergizes with an OX40-agonist antibody resulting in synergistic anti-tumor response and survival in an animal model of colorectal cancer by bridging the innate and adaptive arms of the immune system

Date:

Monday, April 01, 2019

Time:

8:00 AM-12:00 PM ET

Session:

Late Breaking Research- Immunotherapy 1

Location:

Georgia World Congress Center, Exhibit Hall B, Section 41

About BXCL701:

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 (FAP). 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.