Poster presentation scheduled for June 1, 2024, 1:30-4:30 PM CT /2:30-5:30 PM ET

Trial being led by Georgetown University's Lombardi Comprehensive Cancer Center

NEW HAVEN, Conn., April 24, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (NASDAQ:BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced that a late-breaking abstract with preliminary findings from the Phase 2 investigator-sponsored trial of BXCL701 in combination with KEYTRUDA (pembrolizumab) in previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) has been selected for presentation in a poster session at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The meeting will take place from May 31 to June 4, 2024 in Chicago, IL.

The trial, which is led by investigators at Georgetown University's Lombardi Comprehensive Cancer Center, is evaluating BXCL701, an investigational, oral innate immune activator designed to inflame the tumor microenvironment and thereby augment the activity of checkpoint inhibitors. On February 6, 2024, BioXcel Therapeutics announced the completion of patient enrollment in the safety lead-in portion of the trial. Through its OnkosXcel Therapeutics immuno-oncology subsidiary, BioXcel Therapeutics is collaborating with Dr. Louis M. Weiner, director of the Lombardi Comprehensive Cancer Center, and Dr. Benjamin Weinberg, principal investigator of the study. BioXcel Therapeutics and Merck & Co. are providing BXCL701 and KEYTRUDA for the trial, respectively.

Poster Presentation*

Title: Phase 2 Trial of BXCL701 and Pembrolizumab in Patients with Metastatic Pancreatic Ductal Adenocarcinoma (EXPEL-PANC): Preliminary Findings

Presenter: Dr. Benjamin Weinberg, Ruesch Center for the Cure of Gastrointestinal Cancers, Lombardi Comprehensive Cancer Center

Abstract: LBA4132

Poster: 112

Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Date: June 1, 2024

Time: 1:30-4:30 PM CT /2:30-5:30 PM ET

*The poster abstract will be released at 7:00 AM CT /8:00 AM ET on the day of the presentation.

About BXCL701
BXCL701 is an investigational, oral innate immune activator designed to initiate inflammation in the tumor microenvironment. Approved and experimental immunotherapies often fail to address cancers that appear "cold." Therefore, BXCL701 is being evaluated to determine if it can render "cold" tumors "hot," making them more detectable by the adaptive immune system and thereby facilitating the development of a strong anticancer immune response. OnkosXcel Therapeutics' preclinical data support BXCL701's potential synergy with both current checkpoint inhibitors and emerging immunotherapies directed to activate T-cells. BXCL701 is currently being developed as a potential therapy for the treatment of aggressive forms of prostate cancer and advanced solid tumors that are refractory or treatment naïve to checkpoint inhibitors. BXCL701 has received Orphan Drug Designation from the U.S. Food and Drug Administration in four indications: acute myelogenous leukemia, pancreatic cancer, stage IIb to IV melanoma, and soft tissue sarcoma. The U.S. Food and Drug Administration (FDA) designated as a Fast Track development program the investigation of BXCL701 in combination with a checkpoint inhibitor for treatment of patients with metastatic small cell neuroendocrine prostate cancer (SCNC) with progression on chemotherapy and no evidence of microsatellite instability. An 800+-subject clinical database, with data collected by the Company and others, supports the ongoing development of BXCL701.