-BHV-1510 is a novel trophoblast cell surface antigen-2
(Trop-2) directed antibody drug conjugate (ADC) that has
demonstrated a highly differentiated preclinical monotherapy
efficacy profile, the potential for broader therapeutic margin than
other Trop-2 ADCs currently in development, and synergistic affects
when combined with anti-PD1 therapy
-Biohaven also entered into a clinical supply agreement with
Regeneron to study the combination of BHV-1510 with Regeneron's
anti-PD-1 Libtayo® (cemiplimab-rwlc) in the Phase 1/2
clinical trial
-Malignancies of epithelial tissue account for the vast
majority of all cancers and the advanced or metastatic
forms of these carcinomas represent an urgent unmet medical
need
NEW
HAVEN, Conn., May 29, 2024
/PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) (Biohaven), a global
clinical-stage biopharmaceutical company focused on the discovery,
development and commercialization of life-changing therapies to
treat a broad range of rare and common diseases, announced the
first patient has been dosed in a first-in-human Phase 1/2 study of
BHV-1510, a highly differentiated Trophoblast Cell Surface
Antigen-2 (Trop-2) directed Antibody Drug Conjugate (ADC), and the
lead ADC program to advance into clinical trials in Biohaven's
growing oncology pipeline.
The Phase 1/2 study of BHV-1510 is a multicenter, open-label
study in subjects with select advanced or metastatic epithelial
cell tumors. The trial consists of a dose-escalation phase,
followed by a multicohort expansion phase. Additional information
can be found at https://www.clinicaltrials.gov/ (NCT06384807).
"We are extremely proud to advance our first oncology clinical
program with a potentially best in class ADC," said Nushmia Khokhar, M.D., Chief Medical Officer of
Oncology at Biohaven. "With the initiation of this monotherapy
study, we are one step closer to providing differentiated and
superior treatment options to people living with cancer. We are
also excited to work with Regeneron and efficiently explore
BHV-1510 in combination with its PD-1 inhibitor
Libtayo® across a range of tumors."
BHV-1510 is a next-generation, fully optimized ADC that consists
of a Trop-2 directed antibody conjugated to a proprietary
best-in-class Topoisomerase 1 (TopoIx) payload at a homogeneous
drug-antibody ratio (DAR) of 4. BHV-1510 incorporates a unique
site-specific conjugation methodology and highly stable and
irreversible linker chemistry designed by GeneQuantum Healthcare
Co. (Suzhou) Ltd. Preclinically BHV-1510 has shown superior
cellular cytotoxicity, bystander killing, and immunogenic cell
death resulting in improved efficacy as monotherapy, and
synergistic efficacy in combination with anti-PD-1 therapy. In
IND-enabling studies, BHV-1510 also showed a broader therapeutic
margin relative to more advanced Trop-2 ADCs, including a lack of
lung toxicity, that may translate to an improved clinical efficacy
and safety profile.
Shiraj Sen M.D., Ph.D., Director
of NEXT Oncology-Dallas, commented, "Antibody drug conjugates have
shown promising efficacy in solid tumors, but their clinical
potential is currently limited by their safety margin. BHV-1510 has
compelling and differentiated preclinical data, with the potential
to translate to better safety and efficacy in several tumors
including those with significant unmet need. We are excited
to be working with the Biohaven team on this important clinical
trial for patients with advanced epithelial tumors."
Biohaven entered into a clinical supply agreement with Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) under which Biohaven will
sponsor and fund the planned clinical trial and Regeneron will
provide Libtayo. Libtayo is a fully-human monoclonal antibody
targeting the immune checkpoint receptor PD-1 (programmed cell
death protein-1).
Brian Lestini, M.D., Ph.D.,
President of Oncology at Biohaven stated, "Biohaven's ADC
technology and portfolio has the potential to differentiate from
current ADCs in the market that use older payloads or maleimide
linkers. The advancement of our lead ADC program, BHV-1510, into
clinic as both monotherapy and in combination with Regeneron's
anti-PD-1 represents an important first opportunity to show the
breadth and differentiation of Biohaven's extensive ADC pipeline.
Coupled with our deep in-house expertise in oncology clinical
development, ADC chemistry, and complex manufacturing, we believe
our diverse and growing ADC portfolio positions Biohaven for future
leadership in oncology."
Biohaven is developing a broad portfolio of highly
differentiated ADCs with the potential to broaden therapeutic
margin, increase time on treatment, and improve efficacy.
Biohaven's proprietary MATE™ platform technology focuses on novel,
single-step conjugation chemistry, with the potential to be
superior to the current industry standard maleimide and lipophilic
click chemistry.
About Biohaven
Biohaven is a biopharmaceutical company focused on the
discovery, development, and commercialization of life-changing
treatments in key therapeutic areas, including immunology,
neuroscience, and oncology. The company is advancing its innovative
portfolio of therapeutics, leveraging its proven drug development
experience and multiple proprietary drug development platforms.
Biohaven's extensive clinical and preclinical programs include Kv7
ion channel modulation for epilepsy and mood disorders;
extracellular protein degradation for immunological diseases; TRPM3
antagonism for migraine and neuropathic pain; TYK2/JAK1 inhibition
for neuroinflammatory disorders; glutamate modulation for OCD and
SCA (spinocerebellar ataxia); myostatin inhibition for
neuromuscular and metabolic diseases, including SMA and obesity;
antibody recruiting bispecific molecules and antibody drug
conjugates for cancer. For more information, visit
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 FDA; the timing and outcome of expected regulatory
filings; complying with applicable U.S. regulatory requirements;
the potential commercialization of Biohaven's product candidates;
the potential for Biohaven's product candidates to be first in
class therapies; 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 news 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.
MATE™ is a trademark of Biohaven Therapeutics Ltd.
Libtayo® is a registered trademark of Regeneron Pharmaceuticals,
Inc.
Investor Contact:
Jennifer
Porcelli
Vice President, Investor Relations
jennifer.porcelli@biohavenpharma.com
+1 (201) 248-0741
Media Contact:
Mike
Beyer
Sam Brown Inc.
mikebeyer@sambrown.com
+1 (312) 961-2502
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SOURCE Biohaven Ltd.