NEW HAVEN, Conn., Oct. 27, 2021 /PRNewswire/ -- Biohaven
Pharmaceutical Holding Company Ltd. (NYSE: BHVN), announced the
enrollment of the first patient in a Phase 1a/1b trial in Multiple Myeloma using the ARM,
BHV-1100, in combination with autologous cytokine induced
memory-like (CIML) natural killer (NK) cells and immunoglobulin
(Ig) to target and kill multiple myeloma cells expressing the cell
surface protein CD38 (Figure 1). BHV-1100 is the lead clinical
asset from Biohaven's ARM Platform, developed from a strategic
alliance with PeptiDream Inc. This clinical trial will assess the
safety and tolerability, as well as exploratory efficacy endpoints,
in newly diagnosed multiple myeloma patients who have tested
positive for minimal residual disease (MRD+) in first remission
prior to autologous stem cell transplant (ASCT).
NK cells are part of the innate immune system, which is designed
to recognize and destroy "non-self" or diseased cells in the body.
However, tumor cells can evade detection by immune effector cells,
allowing the tumor to advance. BHV-1100 targets a cell-surface
protein, CD38, that is heavily overexpressed on multiple myeloma
and binds to it, recruiting primed autologous cytokine induced
memory-like (CIML) natural killer (NK) cells to destroy the
tumor.
Charlie Conway, Ph.D., Chief
Scientific Officer at Biohaven commented, "While many recent
advances have been made to benefit multiple myeloma patients, most
patients will unfortunately still relapse. We are excited to
investigate BHV-1100 for its ability to recruit autologous CIML NK
cells to the site of the tumor. Based on preclinical data from
Biohaven Labs, we anticipate that our CD38 targeting ARM-enabled NK
cells will kill CD38-positive multiple myeloma cells, and recruit
other immune effector cells to assist in reducing the tumor
burden."
Biohaven has initiated enrollment in the clinical trial and
plans to enroll 25 patients for this single-center, open-label
study (ClinicalTrials.gov Identifier: NCT04634435;
https://clinicaltrials.gov/ct2/show/NCT04634435). The study will
enroll newly diagnosed multiple myeloma patients who have minimal
residual disease (MRD+) in first remission prior to an autologous
stem cell transplant (ASCT).
David Spiegel M.D., PhD, inventor
of the ARM technology and Professor of Chemistry and Pharmacology
at Yale University, commented, "This is
an important milestone in the development of the ARM therapeutic
platform – taking a novel technology from 'benchtop to bedside'. It
also highlights Biohaven's commitment to benefit patients in
need."
About ARMs: Antibody Recruiting Molecules
ARMs, antibody recruiting molecules, are engineered with
modular components that are readily interchangeable, giving the
platform tremendous flexibility and rapid development timelines.
ARM compounds are being developed at Biohaven Labs to redirect a
patient's own antibodies for therapeutic effect with multiple
benefits over traditional monoclonal antibody therapies, including
the potential for oral dosing. For BHV-1100, the ARM platform is
being used to provide antigen targeting to NK cell-based therapies
without genetic engineering. This NK cell targeting approach is
also being investigated with allogeneic, or 'off-the-shelf', immune
cell-based therapies.
About Multiple Myeloma
Multiple myeloma is a type of blood cancer of the plasma cell that
develops in the bone marrow, the soft tissue inside our
bones. Healthy plasma cells produce antibodies, which are
critical for the immune system's ability to recognize
disease-causing entities, such as bacteria, viruses and tumor
cells. In multiple myeloma, however, genetic abnormalities in
a single plasma cell cause it to divide uncontrollably. This leads
to the over-production of a single (monoclonal) antibody protein,
referred to as an "M protein". Also, these cancerous cells divide
to the point of crowding out normal, healthy cells that reside in
the bone marrow. Many patients are diagnosed due to symptoms such
as bone pain or fractures, kidney failure (thirst, dehydration,
confusion), nerve pain, fever, and weakness. The American Cancer
Society estimates that approximately 34,920 new cases will be
diagnosed, and 12,410 deaths will occur in 2021 from multiple
myeloma.
About Biohaven
Biohaven is a commercial-stage
biopharmaceutical company with a portfolio of innovative,
best-in-class therapies to improve the lives of patients with
debilitating neurological and neuropsychiatric diseases, including
rare disorders and areas of unmet need. Biohaven's neuro-innovation
portfolio includes FDA-approved NURTEC® ODT (rimegepant) for the
acute and preventive treatment of migraine and a broad pipeline of
late-stage product candidates across three distinct mechanistic
platforms: CGRP receptor antagonism for the acute and preventive
treatment of migraine; glutamate modulation for
obsessive-compulsive disorder, Alzheimer's disease, and
spinocerebellar ataxia; and MPO inhibition for amyotrophic lateral
sclerosis. More information about Biohaven is available
at www.biohavenpharma.com.
About PeptiDream
PeptiDream Inc. is a public (Tokyo Stock Exchange 1st Section
4587) biopharmaceutical company founded in 2006 employing their
proprietary Peptide Discovery Platform System (PDPS), a
state-of-the-art highly versatile discovery platform which enables
the production of highly diverse (trillions) non-standard peptide
libraries with high efficiency, for the identification of highly
potent and selective hit candidates, which then can be developed
into peptide-based, small molecule-based, or
peptide-drug-conjugate-based therapeutics. PeptiDream aspires to be
a world leader in drug discovery and development to address unmet
medical needs and improve the quality of life of patients
worldwide. Further information regarding PeptiDream can be found
at: www.peptidream.com.
Forward-looking Statement
This news release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
These forward-looking statements involve substantial risks and
uncertainties, including statements that are based on the current
expectations and assumptions of Biohaven's management about
BHV-1100 as a treatment for multiple myeloma. Forward-looking
statements include those related to: Biohaven's ability to
effectively develop and commercialize BHV-1100, delays or problems
in the supply or manufacture of BHV-1100, complying with
applicable U.S. regulatory requirements, 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, the potential commercialization of Biohaven's product
candidates, the potential for Biohaven's product candidates to be
first in class or best in class therapies and the
effectiveness and safety of Biohaven's product candidates. Various
important factors could cause actual results or events to differ
materially from those that may be expressed or implied by our
forward-looking statements. Additional important factors to be
considered in connection with forward-looking statements are
described in the "Risk Factors" section of Biohaven's Annual Report
on Form 10-K for the year ended December 31,
2020, filed with the Securities and Exchange Commission
on March 1, 2021, and Biohaven's subsequent filings with the
Securities and Exchange Commission. The forward-looking statements
are made as of this date 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.
NURTEC and NURTEC ODT are registered trademarks of Biohaven
Pharmaceutical Ireland DAC.
Neuroinnovation is a trademark of Biohaven Pharmaceutical Holding
Company Ltd.
ARM is a trademark of Kleo Pharmaceuticals, Inc.
Biohaven Contact
Dr. Vlad Coric
Chief Executive Officer
Vlad.Coric@biohavenpharma.com
Media Contact
Mike Beyer
Sam Brown Inc.
mikebeyer@sambrown.com
312-961-2502
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.