Bolt Biotherapeutics Announces Clinical Collaboration with Bristol Myers Squibb to Study BDC-1001 in Combination with Opdivo® for Treatment of HER2-Expressing Solid Tumors
08 September 2021 - 9:30PM
Bolt Biotherapeutics, Inc. (Nasdaq: BOLT), a clinical-stage
biotechnology company pioneering a new class of immuno-oncology
agents that combine the targeting precision of antibodies with the
power of both the innate and adaptive immune systems, today
announced that it has entered into a clinical collaboration and
supply agreement with Bristol Myers Squibb (NYSE: BMY) to
investigate Bolt Biotherapeutics’ BDC-1001 in combination with
Bristol Myers Squibb’s PD-1 checkpoint inhibitor Opdivo®
(nivolumab). BDC-1001 is a HER2-targeting Boltbody™
immune-stimulating antibody conjugate (ISAC) in development for the
treatment of patients with HER2-expressing solid tumors.
“We look forward to working with BMS in our continued
development of BDC-1001, which has shown promising results in
preclinical and early clinical studies,” said Randall Schatzman,
CEO of Bolt Biotherapeutics. “Our unique ISAC approach initiates an
innate and an adaptive immune response that may be synergistic with
BMS’ innovative PD-1 inhibitor Opdivo. The combination of BDC-1001
and Opdivo holds potential as a treatment for cancer patients, and
we welcome the opportunity to investigate this in a clinical
setting.” He added, “We remain grateful to all of the healthcare
professionals, scientists, patients, and families involved with
Bolt’s clinical studies.”
BDC-1001 is a human epidermal growth factor receptor 2 (HER2)
ISAC comprised of a HER2-targeting biosimilar of trastuzumab
conjugated to one of Bolt’s proprietary TLR7/8 agonists with an
intervening non-cleavable linker, for the treatment of patients
with HER2-expressing solid tumors. It is currently being
investigated in a Phase 1/2 clinical trial (NCT04278144) in
patients with solid tumors, including breast, gastroesophageal and
colorectal, that are HER2+ or HER2-low, for which Bolt recently
presented preliminary data detailing safety, tolerability, and
signs of activity at the 2021 American Society of Clinical Oncology
(ASCO) Annual Meeting. The trial is being conducted in four parts,
with dose-escalation and dose-expansion parts exploring both
monotherapy and combination with a PD-1 checkpoint inhibitor. BMS
will provide Opdivo for the combination dose escalation and
combination dose expansion portions of the trial. Bolt
Biotherapeutics is the study sponsor and will be responsible for
costs associated with the trial execution. The combination dose
escalation is expected to start later in 2021.
Opdivo® is a trademark of Bristol-Myers Squibb Company.
About the Boltbody™ Immune-Stimulating Antibody
Conjugate (ISAC) PlatformISACs are a new category of
immunotherapy that combines the precision of antibody targeting
with the strength of the innate and adaptive immune systems.
Boltbody ISACs are comprised of three primary components: a
tumor-targeting antibody, a non-cleavable linker, and a proprietary
immune stimulant to activate the patient’s innate immune system. By
initially targeting a single marker on the surface of a patient’s
tumor cells, an ISAC can create a new immune response by activating
and recruiting myeloid cells. The activated myeloid cells start a
feed-forward loop by releasing cytokines and chemokines, chemical
signals that attract other immune cells and lower the activation
threshold for an immune response. This reprograms the tumor
microenvironment and invokes an adaptive immune response that
targets the tumor, with the goal of durable responses for patients
with cancer.
About Bolt Biotherapeutics, Inc.Bolt
Biotherapeutics, Inc. is a clinical-stage biotechnology company
pioneering a new class of immuno-oncology agents that combine the
targeting precision of antibodies with the power of both the innate
and adaptive immune systems. Bolt’s proprietary Boltbody™
Immune-stimulating Antibody Conjugates (ISACs) are designed to
target tumor cells for elimination by myeloid cells, which then
activates the myeloid cells to recruit the adaptive immune system
in the anti-tumor response. This leads to the conversion of
immunologically “cold” tumors to “hot” tumors. Bolt’s lead
candidate, BDC-1001, is a Boltbody ISAC comprised of a
HER2-targeting biosimilar of trastuzumab conjugated with a
non-cleavable linker to one of Bolt’s proprietary TLR7/8 agonists
for the treatment of patients with HER2-expressing solid tumors.
Bolt is also advancing BDC-2034, a Boltbody ISAC targeting CEA, and
a pipeline of other immuno-oncology products.
Forward-Looking StatementsThis press release
contains forward-looking statements about us and our industry that
involve substantial risks and uncertainties and are based on our
beliefs and assumptions and on information currently available to
us. All statements other than statements of historical facts
contained in this press release, including statements regarding our
ability to collaborate with Bristol-Myers Squibb to investigate
combination therapeutics for the treatment of cancer, our future
results of operations, financial condition, business strategy and
plans and objectives of management for future operations, are
forward-looking statements. In some cases, you can identify
forward-looking statements because they contain words such as
“anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,”
“may,” “plan,” “potential,” “predict,” “project,” “should,” “will,”
or “would,” or the negative of these words or other similar terms
or expressions. Forward-looking statements involve known and
unknown risks, uncertainties and other factors that may cause our
actual results, performance or achievements to be materially
different from any future results, performance or achievements
expressed or implied by the forward-looking statements.
Forward-looking statements represent our current beliefs, estimates
and assumptions only as of the date of this press release and
information contained in this press release should not be relied
upon as representing our estimates as of any subsequent date. These
statements, and related risks, uncertainties, factors and
assumptions, include, but are not limited to: the potential product
candidates that we develop may not progress through clinical
development or receive required regulatory approvals within
expected timelines or at all; clinical trials may not confirm any
safety, potency or other product characteristics described or
assumed in this press release; such product candidates may not be
beneficial to patients or become commercialized. These risks are
not exhaustive. Except as required by law, we assume no obligation
to update these forward-looking statements, or to update the
reasons actual results could differ materially from those
anticipated in the forward-looking statements, even if new
information becomes available in the future. Further information on
factors that could cause actual results to differ materially from
the results anticipated by our forward-looking statements is
included in the reports we have filed or will file with the SEC,
including our Quarterly Report on Form 10-Q for the three months
ended March 31, 2021. These filings, when available, are available
on the investor relations section of our website at
investors.boltbio.com and on the SEC’s website at www.sec.gov.
Investor Relations and Media Contacts: Karen L.
BergmanVice President, Communications and Investor RelationsBolt
Biotherapeutics, Inc.650-665-9295 kbergman@boltbio.com
Sarah McCabeStern Investor Relations,
Inc.212-362-1200sarah.mccabe@sternir.com
Maggie Beller or David Schull Russo Partners, LLC 646-942-5631
maggie.beller@russopartnersllc.com
david.schull@russopartnersllc.com
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