- Novel first-in-class, brain-penetrant, dual inhibitor of
TYK2/JAK1 offers wide therapeutic index with TYK2 inhibition and
high selectivity for JAK1 inhibition without the severely limiting
adverse class effects of JAK2/JAK3 inhibitors
- Exclusive license covers global rights excluding China region
- Biohaven anticipates initiating Phase 1 clinical development in
2023
NEW
HAVEN, Conn., March 22,
2023 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN)
today announced that it acquired global rights, excluding
China regions, for the development
of an oral, brain-penetrant, dual inhibitor of Tyrosine Kinase
2 (TYK2) and Janus Kinase 1 (JAK1) for the treatment of brain
disorders. BHV-8000 (previously TLL-041) was licensed from Hangzhou
Highlightll Pharmaceutical Co. Ltd. (Highlightll) and Biohaven
anticipates advancing the agent into a Phase 1 study in 2023.
Dysregulation of the immune system has been implicated in
several neurodegenerative and neuroinflammatory disorders including
Parkinson's Disease, Multiple Sclerosis, Alzheimer's Disease,
Amyotrophic Lateral Sclerosis and Autoimmune Encephalitis.
Over-active immune cells and microglia driving chronic
neuroinflammation results in release of cytokines with activation
of leukocytes and is thought to contribute to neuronal injury,
death, gliosis, and demyelination. The TYK2 and JAK1 signal
transduction pathways mediate highly complementary immune and
inflammatory signaling events. Targeted, small-molecule therapies
that inhibit TYK2 or JAK kinases have separately demonstrated
robust efficacy in autoimmune, dermatologic and gastrointestinal
disorders. TYK2 is a validated immune target as evidenced by a
recent peripheral program that gained FDA approval, and there are
multiple additional peripheral non-CNS programs in clinical
development. Brain penetrant inhibitors of TYK2/JAK1 have the
potential to bring this validated immune target to brain
disorders.
There are currently no brain penetrant, selective, dual
TYK2/JAK1 inhibitors approved for brain disorders.
Vlad Coric, M.D., Chairman and
Chief Executive Officer of Biohaven, commented, "We have gained
tremendous insight into the role of the immune system and critical
inflammatory signaling pathways with events that drive the onset,
propagation and relentless progression of neurodegenerative
diseases. BHV-8000, with its blood-brain barrier penetrant activity
and dual profile of TYK2/JAK1 inhibition, offers the potential for
a unique and highly attractive therapeutic advancement for the
treatment of brain disorders. Dual TYK2/JAK1 inhibition is a novel
target combination and potentiates complementary activities that
permit a graded degree of therapeutic immunomodulation specific to
pathogenic neuroimmune pathways. We look forward to advancing
BHV-8000 into clinical development and uncovering the potential of
neuroimmunomodulation for severe neurological disorders in
desperate need of novel treatment options."
Highlightll was founded by Chris Liang PhD and is focused on the
research and development of small molecules for the treatment of
autoimmune and inflammatory disorders. Dr. Liang is a Princeton trained chemist and seasoned drug
developer who was an inventor of sunitinib and ensartinib. Dr.
Liang oversaw the development of the licensed intellectual
property, and the compound was designed to be brain penetrant while
delivering dual selectivity for TYK2/JAK1 without the toxicity of
JAK2/JAK3.
Chris Liang, Ph.D., Chairman and
Chief Executive Officer of Highlightll, added, "Biohaven's proven
track record in successfully innovating, developing, and
commercializing neuroscience therapies makes them an attractive
partner to help maximize the potential of BHV-8000. We have
delivered what we believe is a best-in-class dual TYK2/JAK1
molecule and the team at Biohaven has the clinical development
expertise to explore its utility in brain disorders. We look
forward to working together to expedite development of this
compound to improve outcomes for patients in need."
Dr. Coric added, "The addition of BHV-8000 expands our growing
and diverse set of complementary neuro-immunomodulatory therapeutic
approaches including selective extracellular degraders (commonly
referred to as LYTACs or MoDEs™) against IgG, IgA, and
antigen-specific targets in development at Biohaven. We are excited
to work with Chris and the team at Highlightll to advance this
novel and highly differentiated dual TYK2/JAK1 inhibitor in the
treatment of brain disorders."
Terms of the Arrangement
Highlightll will receive
$10 million in upfront cash and
$10 million in BHVN equity,
development and commercial milestone payments of up to $950 million, and tiered royalty payments ranging
from mid-single digit to lower teens percentages. Biohaven
and Highlightll will coordinate clinical development across global
regions.
About BHV-8000
BHV-8000 (previously TLL-041) is a
highly selective, brain-penetrant, dual TYK2/JAK1 inhibitor. TYK2
and JAK1 are STAT pathway activators addressing a range of
proinflammatory cytokines; inhibition of these kinases may play a
significant role in reducing inflammation in neurological disorders
including Parkinson's Disease, Alzheimer's Disease, Amyotrophic
Lateral Sclerosis, and Multiple Sclerosis. BHV-8000 has
demonstrated high selectivity over JAK2, JAK3 and other kinases,
potentially offering improved safety over less selective or
non-selective JAK inhibitors. Mechanistic proof of concept for
BHV-8000 has been demonstrated in multiple preclinical models.
About Hangzhou Highlightll Pharmaceutical Co.
Ltd.
Hangzhou Highlightll Pharmaceutical Co. Ltd. is an
innovative drug development company focused on the research and
development of small molecules for the treatment of
autoimmune/inflammatory diseases and central nervous system
diseases. The company's lead project, a peripheral TYK2/JAK1 dual
inhibitor, is being evaluated in clinical trials in the US and
China for immunological
disorders.
About Biohaven
Biohaven is a global clinical-stage
biopharmaceutical company focused on the discovery, development and
commercialization of life-changing therapies for people with
debilitating neurological and neuropsychiatric diseases, including
rare disorders. Biohaven's experienced management team brings
with it a track record of delivering new drug approvals for
products for diseases such as migraine, depression, bipolar and
schizophrenia. The company is advancing a pipeline of
therapies for diseases with little or no treatment options,
leveraging its proven drug development capabilities and proprietary
platforms, including Kv7 ion channel modulation for epilepsy and
neuronal hyperexcitability, glutamate modulation for
obsessive-compulsive disorder and spinocerebellar ataxia and
myostatin inhibition for neuromuscular diseases. Biohaven's
portfolio of early- and late-stage product candidates also includes
discovery research programs focused on TRPM3 channel activation for
neuropathic pain, CD-38 antibody recruiting, bispecific molecules
for multiple myeloma, antibody drug conjugates (ADCs), and
extracellular target degrader platform technology (bispecific MoDE
degraders) with potential application in neurological disorders,
cancer, and autoimmune diseases. More information about Biohaven is
available at www.biohaven.com.
Forward-looking Statements
This news release includes
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. The use of certain words,
including "continue", "plan", "will", "believe", "may", "expect",
"anticipate" and similar expressions, is intended to identify
forward-looking statements. Investors are cautioned that any
forward-looking statements, including statements regarding the
future development, timing and potential marketing approval and
commercialization of development candidates are not guarantees of
future performance or results and involve substantial risks and
uncertainties. Actual results, developments and events may differ
materially from those in the forward-looking statements as a result
of various factors including: the expected timing, commencement and
outcomes of Biohaven's planned and ongoing clinical
trials; the timing of planned interactions and filings with
the Food and Drug Administration; the timing and outcome of
expected regulatory filings; complying with
applicable U.S. regulatory requirements; the potential
commercialization of Biohaven's product candidates; and
the effectiveness and safety of Biohaven's product
candidates. Additional important factors to be considered in
connection with forward-looking statements are described
in Biohaven's filings with the Securities and
Exchange Commission, including within the sections titled "Risk
Factors" and "Management's Discussion and Analysis of Financial
Condition and Results of Operations". The forward-looking
statements are made as of the date of this new release,
and Biohaven does not undertake any obligation to update
any forward-looking statements, whether as a result of new
information, future events or otherwise, except as required by
law.
Biohaven Contact:
Jennifer
Porcelli
Vice President, Investor Relations
jennifer.porcelli@biohavenpharma.com
201-248-0741
Media Contact:
Mike
Beyer
Sam Brown Inc.
mikebeyer@sambrown.com
312-961-2502
MoDEs is a trademark of Biohaven Therapeutics Ltd.
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