BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical
company utilizing artificial intelligence to develop transformative
medicines in neuroscience and immuno-oncology, today announced that
the U.S. Food and Drug Administration (FDA) has designated as a
Fast Track development program the investigation of BXCL701 in
combination with a CPI for the treatment of patients with
metastatic small cell neuroendocrine prostate cancer (SCNC) with
progression on chemotherapy and no evidence of microsatellite
instability. The FDA grants Fast Track designation to facilitate
the development and expedite the review of medicines to treat
serious conditions, fill unmet medical needs, and bring promising
medicines to patients more quickly. Therapies granted this
designation are given the opportunity for more frequent
interactions with the FDA, a rolling review, and potential
eligibility for accelerated approval and priority review.
“The FDA’s Fast Track designation for the investigation of
BXCL701 in SCNC is an important recognition of our most advanced
immuno-oncology asset and an acknowledgment of its potential to
address the considerable unmet medical need in these patients. At
the same time, it further validates the unique AI-based drug
re-innovation approach that we used to discover this asset,”
said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “BXCL701
has already demonstrated considerable potential in our clinical
trials to date, and we plan to further define its development path
while exploring strategic options for our OnkosXcel Therapeutics
subsidiary.”
SCNC, classified as a “cold” tumor, represents an underserved,
growing patient population, with cases increasing due to earlier
and more widespread use of androgen receptor inhibitors. In 2024,
the American Cancer Society estimates that 299,0101 men will
be diagnosed with prostate cancer in the United States, with
approximately 20% expected to progress to the more aggressive
metastatic castration-resistant form, including an estimated 11,960
patients expected to progress to SCNC2.
“SCNC is characterized by poor prognosis and a low survival
rate, and current treatment options are suboptimal,” said Vincent
J. O’Neill, M.D., Executive Vice President, Chief of Product
Development and Medical Officer of BioXcel Therapeutics. “We are
encouraged by the potential of BXCL701, which has demonstrated
clinical proof of concept in both SCNC and adenocarcinoma.
Following the positive survival results from our Phase 2 trial that
we reported at the end of last year, we look forward to further
discussing the registration path at an upcoming meeting with the
FDA.”
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 five
indications: SCNC, acute myelogenous leukemia, pancreatic cancer,
stage IIb to IV melanoma, and soft tissue sarcoma. 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 StatementsThis
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 potential benefits from treatment with BXCL701 and
from fast track designation, potential meeting with the FDA and
strategic options for the OnkosXcel Therapeutics subsidiary. 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 dependence on
the success and commercialization of IGALMI™, BXCL501, BXCL502
BXCL701 and BXCL702 and other product candidates; 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 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 receive
regulatory approval for its product candidates; its ability to
enroll patients in its clinical trials; undesirable side effects
caused by the Company’s product candidates; and its novel approach
to the discovery and development of product candidates based on
EvolverAI, as well as the other important factors discussed under
the caption “Risk Factors” in its Quarterly Report on Form 10-Q for
the quarterly period ended September 30, 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. 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
CorporateBioXcel TherapeuticsErik
Kopp1.203.494.7062ekopp@bioxceltherapeutics.com
Investor RelationsBioXcel TherapeuticsBrennan
Doyle1.475.355.8462bdoyle@bioxceltherapeutics.com
MediaRusso PartnersDavid
SchullT: 858-717-2310David.schull@russopartnersllc.comScott
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.
References
1 American Cancer Society. Key Statistics for Prostate Cancer.
Accessed February 8, 2024
https://www.cancer.org/cancer/types/prostate-cancer/about/key-statistics.html#:~:text=The%20American%20Cancer%20Society's%20estimates,34%2C700%20deaths%20from%20prostate%20cancer2.
B.R. Alabi, S. Liu and T. Stoyanova, Current and emerging therapies
for neuroendocrine prostate cancer, Pharmacology and Therapeutics
(2022), https://doi.org/10.1016/j.pharmthera.2022.108255
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