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 BXCL701BXCL701 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.
About BioXcel Therapeutics, Inc.
BioXcel Therapeutics, Inc. (Nasdaq: BTAI) is a biopharmaceutical
company utilizing artificial intelligence to develop transformative
medicines in neuroscience. Its wholly owned subsidiary, OnkosXcel
Therapeutics, is focused on the development of medicines in
immuno-oncology. The Company’s drug re-innovation approach
leverages existing approved drugs and/or clinically validated
product candidates together with big data and proprietary machine
learning algorithms to identify new therapeutic indications. For
more information, please
visit bioxceltherapeutics.com. Forward-Looking Statements
This press release includes “forward-looking statements” within the
meaning of the Private Securities Litigation Reform Act of 1995. We
intend such forward-looking statements to be covered by the safe
harbor provisions for forward-looking statements contained in
Section 27A of the Securities Act of 1933, as amended (the
“Securities Act”) and Section 21E of the Securities Exchange Act of
1934, as amended (the “Exchange Act”). All statements contained in
this press release other than statements of historical fact should
be considered forward-looking statements, including, without
limitation, the Company’s participation in and content of the
Company’s presentations at 2024 ASCO Annual Meeting and the
potential benefits from treatment with BXCL701. When used herein,
words including “anticipate,” “believe,” “can,” “continue,”
“could,” “designed,” “estimate,” “expect,” “forecast,” “goal,”
“intend,” “may,” “might,” “plan,” “possible,” “potential,”
“predict,” “project,” “should,” “target,” “will,” “would” and
similar expressions are intended to identify forward-looking
statements, though not all forward-looking statements use these
words or expressions. In addition, any statements or information
that refer to expectations, beliefs, plans, projections,
objectives, performance or other characterizations of future events
or circumstances, including any underlying assumptions, are
forward-looking. All forward-looking statements are based upon the
Company’s current expectations and various assumptions. The Company
believes there is a reasonable basis for its expectations and
beliefs, but they are inherently uncertain. The Company may not
realize its expectations, and its beliefs may not prove correct.
Actual results could differ materially from those described or
implied by such forward-looking statements as a result of various
important factors, including, without limitation, its limited
operating history and limited revenue generation; its incurrence of
significant losses; its strategic reprioritization and related
reduction in force may not achieve its intended outcome; its need
for substantial additional funding and ability to raise capital
when needed; its significant indebtedness, ability to comply with
covenant obligations and potential payment obligations related to
such indebtedness and other contractual obligations; the Company
has identified conditions and events that raise substantial doubt
about its ability to continue as a going concern; its limited
experience in drug discovery and drug development; risks related to
the Company’s TRANQUILITY program; risks related to the limited
clinical data supporting potential safety or efficacy of BXCL501
for use in the at-home setting; its dependence on the success and
commercialization of IGALMI, BXCL501, BXCL502, BXCL701 and BXCL702
and other product candidates; interim “top-line” and preliminary
data from its clinical trials may change and result in material
changes in the final data; its ability to receive regulatory
approval from the FDA and comparable foreign authorities for its
product candidates; clinical trials are expensive, time-consuming,
difficult to design, difficult to conduct, and involve an uncertain
income; its lack of experience in marketing and selling drug
products; the risk that IGALMI or the Company’s product candidates
may not be accepted by physicians or the medical community in
general; the Company’s estimated number of episodes of agitation
and its corresponding estimated total addressable market are
subject to inherent challenges and uncertainties; the Company still
faces extensive and ongoing regulatory requirements and obligations
for IGALMI; the failure of preliminary data from its clinical
studies to predict final study results; failure of its early
clinical studies or preclinical studies to predict future clinical
studies; its ability to enroll patients in its clinical trials;
undesirable side effects caused by the Company’s product
candidates; its novel approach to the discovery and development of
product candidates based on EvolverAI; the significant influence of
and dependence on BioXcel LLC; its exposure to patent infringement
lawsuits; its reliance on third parties; its ability to comply with
the extensive regulations applicable to it; impacts from data
breaches or cyber-attacks, if any; the Company is and may in the
future be subject to legal proceedings, claims and investigations
in or outside the ordinary course of business, which could be
costly and time-consuming to defend and could result in unfavorable
outcomes; risks related to unfavorable global political or economic
events and conditions; risks associated with the increased scrutiny
relating to environmental, social and governance (ESG) matters;
risks associated with federal, state or foreign health care “fraud
and abuse” laws; and its ability to commercialize its product
candidates, as well as the important factors discussed under the
caption “Risk Factors” in its Annual Report on Form 10-K for the
fiscal year ended December 31, 2023, as such factors may be updated
from time to time in its other filings with the SEC, which are
accessible on the SEC’s website at www.sec.gov and the Investors
section of the Company’s website at www.bioxceltherapeutics.com.
These and other important factors could cause actual results to
differ materially from those indicated by the forward-looking
statements made in this press release. Any such forward-looking
statements represent management’s estimates as of the date of this
press release. While the Company may elect to update such
forward-looking statements at some point in the future, except as
required by law, it disclaims any obligation to do so, even if
subsequent events cause our views to change. These forward-looking
statements should not be relied upon as representing the Company’s
views as of any date subsequent to the date of this press
release.
Contact Information
Corporate
BioXcel TherapeuticsErik
Kopp1.203.494.7062ekopp@bioxceltherapeutics.com
Investor Relations
BioXcel TherapeuticsBrennan
Doyle1.475.355.8462bdoyle@bioxceltherapeutics.com
Media
Russo PartnersDavid
SchullT: 858-717-2310David.schull@russopartnersllc.com
Scott
StachowiakT: 646-942-5630Scott.stachowiak@russopartnersllc.com
Source: BioXcel Therapeutics, Inc.BT BIOXCEL THERAPEUTICS is a
registered trademark of BioXcel Therapeutics, Inc.All other
trademarks are the properties of their respective owners.Copyright
© 2024, BioXcel Therapeutics, Inc. All rights reserved.
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