Bolt Biotherapeutics Presents Preliminary Results from Phase 1/2 Trial of Lead HER2-targeting Boltbody™ ISAC BDC-1001 at AS...
June 04 2021 - 9:00AM
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 a poster presentation discussing preliminary data
from the Phase 1/2 clinical trial of BDC-1001, Bolt’s lead
candidate, was presented at the 2021 American Society of Clinical
Oncology (ASCO) Annual Meeting, being held virtually from June 4-8,
2021. The poster is titled “Preliminary results from a phase 1/2
study of BDC-1001, a novel HER2 targeting TLR7/8 immune-stimulating
antibody conjugate (ISAC), in patients (pts) with advanced
HER2-expressing solid tumors.”
BDC-1001 is a human epidermal growth factor receptor 2, or HER2,
ISAC comprised of a HER2-targeting biosimilar of trastuzumab
conjugated to one of Bolt’s proprietary TLR7/8 agonists, for the
treatment of patients with HER2-expressing solid tumors, including
HER2-low tumors. As of January 29, 2021, Bolt had treated 20
patients and BDC-1001 appeared to be well tolerated with mild to
moderate adverse events; no dose-limiting toxicities or
drug-related serious adverse events were observed. Clinical
activity was seen in the form of stable disease, reductions in
tumor volume including a confirmed partial response and increases
in pharmacodynamic markers that Bolt believes are consistent with
its proposed mechanism of action.
“This poster reinforces the favorable safety and tolerability
demonstrated in the first 20 patients treated with BDC-1001 in this
first-in-human study in patients with HER2-expressing cancers,”
said Manish R. Sharma, M.D., of START Midwest, a principal
investigator in Bolt’s ongoing BDC-1001 Phase 1/2 trial. “We have
seen signs of activity, including a patient with a confirmed
partial response and others with stable disease, in a population
with diverse tumor types and a median of four prior lines of
therapy.”
The BDC-1001 Phase 1/2 trial is expected to enroll up to a total
of 390 patients and is being conducted in four parts, with
dose-escalation dose-expansion parts exploring both monotherapy and
combination with a PD-1 checkpoint inhibitor. The monotherapy
dose-escalation part of the trial continues to proceed according to
plan, and full results are expected to be presented in the second
half of 2021. Bolt plans to advance to the monotherapy Phase 2
dose-expansion cohorts and the dose-escalation combining BDC-1001
with an anti-PD-1 antibody later this year.
“I am grateful to everyone on the team for their hard work
throughout this trial, especially during the pandemic,” said
Ecaterina Dumbrava, M.D., of The University of Texas MD Anderson
Cancer Center, a principal investigator of the BDC-1001 Phase 1/2
trial. “These initial data provide additional support for the ISAC
targeted approach that stimulates both the innate and adaptive
immune systems in the treatment of cancer patients.”
The abstract and poster from the ASCO presentation can be found
on the ASCO website, as well as on the Bolt website.
About Bolt Biotherapeutics’ Immune-stimulating Antibody
Conjugate (ISAC) Platform TechnologyThe Boltbody™ ISAC
platform technology harnesses the ability of innate immune agonists
to convert cold tumors into immunologically hot tumors, thereby
illuminating tumors to the immune system and allowing them to be
invaded by tumor-killing cells. Boltbody ISACs have demonstrated
the ability to eliminate tumors following systemic administration
as monotherapy in preclinical models and have also led to the
development of immunological memory, which is predicted to
translate into more durable clinical responses for patients.
About the Ongoing BDC-1001 Phase 1/2 Study in Patients
with HER2-Expressing Solid TumorsThe Phase 1/2,
multi-center, open-label study is evaluating the safety,
pharmacokinetics, pharmacodynamics and proof of mechanism of
BDC-1001 in patients with HER2-expressing solid tumors. The first
portion of the study includes a monotherapy dose-escalation phase
in which cohorts of patients will receive ascending intravenous
doses of BDC-1001 to determine the maximum tolerated dose and/or
the recommended dose to advance into expansion cohorts and Phase 2
based on safety and tolerability. The second portion of the study
is a dose expansion phase in which patients will receive BDC-1001
monotherapy to further evaluate the safety, tolerability and
clinical antitumor activity of the recommended Phase 2 dose. The
study also includes similar dose escalation and expansion portions
evaluating the combination of BDC-1001 with an anti-PD1 checkpoint
inhibitor. Please refer to www.clinicaltrials.gov NCT04278144 for
additional clinical trial information.
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 Conjugate (ISAC) approach uses
immunostimulants to engage and activate myeloid cells that directly
kill tumor cells. 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 to one of Bolt’s proprietary TLR7/8 agonists
for the treatment of patients with HER2-expressing solid tumors.
Bolt is also advancing additional Boltbody ISAC product candidates
targeting CEA and PD-L1. For more information, visit
https://www.boltbio.com/.
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
clinical trials, the timing of enrollment for our Phase 1/2 trial
for BDC-1001 for the treatment of patients with HER2-expressing
solid tumors, the potential of BDC-1001’s anti-tumor activity while
minimizing the formation of anti-drug antibodies, the potential
that APCs may result in a productive and durable anti-tumor immune
response, and the prediction that Boltbody ISACs may translate into
more durable clinical responses for patients. 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 Securities and Exchange Commission, including
our Annual Report on Form 10-K for the year ended December 31,
2020. 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.
Media Contacts:Maggie Beller or David
SchullRusso Partners,
LLC646-942-5631maggie.beller@russopartnersllc.comdavid.schull@russopartnersllc.com
Investor Relations Contact:Sarah McCabeStern
Investor Relations, Inc.212-362-1200sarah.mccabe@sternir.com
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