BioXcel Therapeutics, Inc. (BTI) Is Launched with Phase 2-ready Programs Addressing Unmet Needs in Immuno-oncology and Neuros...
May 10 2017 - 9:00AM
BioXcel Corporation, a privately held biopharmaceutical company
pioneering the integration of big data analytics and machine
learning-based artificial intelligence (AI) with drug development
expertise to advance the next wave of medicines, today announced
the formation of BioXcel Therapeutics, Inc. (BTI), to focus on the
development of lead programs in immuno-oncology, BXCL701, and in
neuropsychiatric and neurodegenerative diseases, BXCL501.
Using its proprietary AI-powered R&D engine, BioXcel has
identified a number of highly promising therapeutic candidates with
applications across the therapeutic spectrum. BTI was established
as a biotechnology company to capitalize on these promising
therapeutic candidates with the mission of developing innovative
treatments to address unmet medical needs in immuno-oncology and
neuroscience. BTI’s drug re-innovation approach has significantly
de-risked both BXCL701 and BXCL501, and this will further result in
future drug candidates with the potential to provide therapeutic
benefit to patients, while carrying lower development and
regulatory risks.
Vimal Mehta, Ph.D., co-founder, Chairman and Chief Executive
Officer of BioXcel has been appointed Chairman and Chief Executive
Officer of BTI, Frank Yocca, Ph.D., has been appointed Chief
Scientific Officer and Luca Rastelli, Ph.D., has been appointed
Vice President of Oncology and Translational Sciences of BTI. In
addition to Dr. Mehta, BioXcel Therapeutics’ Board of Directors
includes accomplished pharmaceutical industry executives:
- Peter Mueller, Ph.D., joins the BTI Board of
Directors with more than 30 years of pharma and biotech expertise
through senior-level positions at leading companies such as Axcella
Health, Inc., where he served as Chief Scientific Officer and
President of Research & Development, Vertex Pharmaceuticals,
Inc. and Boehringer Ingelheim Pharmaceuticals, Inc. During his
career, Dr. Mueller has been responsible for the development and
approval of several drug products including Spiriva®, Combivent®,
Atrovent®, Incivek® and Kalydeco®, as well as the development and
NDA/MAA submission for Orkambi®. Dr. Mueller is President of The
Mueller Health Foundation, an organization he created, dedicated to
the eradication of global, lethal infectious diseases, with a
primary focus on tuberculosis.
- Eric Rowinsky, M.D., brings to BTI’s Board of
Directors nearly 30 years of experience in oncology drug
development. As Chief Medical Officer of ImClone Systems, he led
the development of Erbitux® (cetuximab), and has contributed to the
development programs for several oncology drugs such as
ramucirumab, necitumumab, paclitaxel, docetaxel, topotecan,
erlotinib, irinotecan, lapatinib, and cixutumumab, among others.
Dr. Rowinsky currently serves as a Director of a number of
biotechnology and pharmaceutical companies including Biogen, Inc.
(NASDAQ:BIIB), Fortress Biotech, Inc. (NASDAQ:FBIO) and Verastem,
Inc. (NASDAQ:VSTM).
- Krishnan Nandabalan, Ph.D., is co-founder,
President and Chief Scientific Officer of BioXcel Corporation. Dr.
Nandabalan is a pioneer and innovator in the application of AI to
biopharma R&D. In addition to his work at the intersection of
technology and biopharmaceutical R&D, Dr. Nandabalan has played
important roles in licensing, discovery and development of oncology
and neuroscience therapeutics and diagnostic products.
"We have formed an incredibly talented leadership team and Board
of Directors to support the development of BTI’s lead clinical
programs. Each member of the organization has played a critical
role in the successful expansion and advancement of clinical
pipelines within leading pharmaceutical and biotechnology
companies. This leadership team brings a deep understanding of both
immuno-oncology and neuroscience, making them ideally suited to
maximize the potential of BTI’s pipeline and accelerate the
company's strategy," said Dr. Vimal Mehta, Chairman and CEO of
BTI.
BXCL701 is a first-in-class DPP8-9/FAP inhibitor with a
well-established mechanism of action, PK/PD and safety profile. BTI
is initially developing BXCL701 in Castration Resistant Prostate
Cancer (CRPC), both as monotherapy and in combination with other
immuno-oncology agents. BXCL701 has broad immuno-modulatory
properties, making it suitable for combination with other
therapeutic modalities, vaccines, CAR-T and CAR-NK and targeted
therapies. The Company believes that BXCL701 has the potential to
be applied to a variety of other tumor types with high unmet
medical need, including pancreatic cancer, non-small cell lung
cancer (NSCLC) and head and neck cancers, among others.
BXCL501 is a first in class selective alpha 2a receptor agonist
for treating acute agitation in schizophrenic and bipolar patients.
BXCL501 is a proprietary sublingual formulation of an FDA-approved
anesthetic that has demonstrated anti-agitation effects both
pre-clinically and clinically. Given the established profile of
BXCL501, BTI plans to pursue regulatory approval of BXCL501 via the
505(b)(2) pathway. BTI believes BXCL501 addresses a very important
need in the treatment of agitation, and is both patient and
caregiver centric.
“The establishment of BTI is a significant milestone for BioXcel
Corporation, and an important step toward achieving our goal of
maximizing the value of these highly promising therapeutic
programs. Our lead programs are clinically-validated drug
candidates targeting areas of high unmet medical need, each with a
clear path to market,” added Dr. Mehta. “We are on-track to
initiate human proof-of-concept trials of both BXCL701 and BXCL501,
and are excited for the opportunities that lie ahead as we advance
the development of these emerging therapeutic candidates.”
About BioXcel Therapeutics, Inc. (BTI):BioXcel
Therapeutics, Inc. is engaged in the development and advancement of
the next wave of medicines, initially targeting the treatment of
immuno-oncology and neuroscience diseases. The company’s lead
therapeutic candidates are BXCL701, a first-in-class DPP8-9/FAP
inhibitor with broad potential application in oncology indications,
both as a monotherapy and in combination with immuno-oncology
agents, and BXCL501, a proprietary sublingual formulation of an
anesthetic for the treatment of acute agitation, with the potential
to expand into other neuropsychiatric and neurodegenerative
disorders. The company’s strategy is to apply a drug re-innovation
approach to develop therapeutic candidates with a high probability
of clinical and regulatory success. For more information, please
visit www.bioxceltherapeutics.com.
About BioXcel Corporation:BioXcel is a
biopharmaceutical company pioneering the integration of big data
analytics and machine learning-based artificial intelligence with
drug development expertise to advance the next wave of medicines,
impacting the probability of success of drugs. The company’s focus
is to develop innovative medicines that address immuno-oncology,
neuroscience and rare diseases with high unmet medical need.
Committed to innovation, product excellence and partner success,
BioXcel Corporation's global collaborations span the
biopharmaceutical ecosystem. Headquartered in Branford, CT, USA,
the company is supported by a R&D Center of Excellence in
India. For more information, please visit
www.bioxcel.com.
Contact Information:
The Ruth Group for BioXcel Therapeutics:
Lee Roth / Janhavi Mohite
646-536-7012 / 7026
lroth@theruthgroup.com / jmohite@theruthgroup.com
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