Bolt Biotherapeutics Initiates Phase 2 Clinical Studies of BDC-1001 in Patients With HER2-Positive Cancer
August 03 2023 - 7:30AM
Bolt Biotherapeutics, Inc. (Nasdaq: BOLT), a clinical-stage
biopharmaceutical company developing novel immunotherapies for the
treatment of cancer, today announced that the first patients have
been dosed in a Phase 2 dose-expansion clinical trial investigating
BDC-1001, a HER2-targeting Boltbody™ Immune-Stimulating Antibody
Conjugate (ISAC). The trial will explore BDC-1001 monotherapy
treatment in three discreet cohorts for patients with HER2-positive
colorectal, endometrial and gastroesophageal cancers.
“This is an important milestone for our company that builds on
the positive signal of monotherapy activity that we observed in the
Phase 1 portion of the study,” said Edith A. Perez, M.D., Chief
Medical Officer of Bolt Biotherapeutics. “Despite considerable
advances in anti-cancer therapy, HER2-positive tumors remain
difficult to treat, and new therapeutic options are urgently
needed. Our ISAC platform brings a novel mechanism with the
potential to address refractory and recurrent disease to the
treatment of HER2+ cancers and BDC-1001 has demonstrated promise.
We are committed to advancing this study for the benefit of the
many patients in need.”
Bolt’s BDC-1001 Phase 2 program includes discrete cohorts across
four different HER2-positive tumor types and utilizes a Simon
two-stage design with the aim of replicating the approximately 30%
objective response rate previously demonstrated in the Phase 1
study. The Phase 2 dose-expansion trial is initially investigating
BDC-1001 as a monotherapy in each of the three separate cohorts
(HER2-positive colorectal, endometrial, and gastroesophageal
cancer). This multi-center, open-label Phase 2 trial will evaluate
the efficacy, safety, tolerability, pharmacokinetics, and
pharmacodynamics of BDC-1001 administered intravenously at 20 mg/kg
every other week (q2w). Please refer to clinicaltrials.gov
[NCT04278144] for additional information.
The company is conducting an additional Phase 2 study, a
randomized two-arm Phase 2 trial investigating BDC-1001 in patients
with HER2-positive metastatic breast cancer whose disease
progressed following treatment with Enhertu®.
About BDC-1001
Bolt Biotherapeutics’ lead program, BDC-1001, is a human
epidermal growth factor receptor 2 (HER2) ISAC comprising a
HER2-targeting biosimilar of trastuzumab conjugated with a
non-cleavable linker to a proprietary TLR7/8 agonist. Following the
successful completion of the BDC-1001 dose-escalation trial for the
treatment of patients with HER2-expressing solid tumors, Bolt is
now conducting two Phase 2 clinical trials (NCT04278144 and
NCT05954143) in patients with HER2-positive solid tumors in the
U.S., Europe, and South Korea.
About the Boltbody™ Immune-Stimulating Antibody
Conjugate (ISAC) Platform
Bolt Biotherapeutics’ Boltbody ISAC platform harnesses the
precision of antibodies with the power of the innate and adaptive
immune system to reprogram the tumor microenvironment to generate a
productive anti-cancer response. Each Boltbody ISAC candidate
comprises a tumor-targeting antibody, a non-cleavable linker and a
proprietary immune stimulant. The antibody is designed to target
one or more markers on the surface of a tumor cell, and the immune
stimulant is designed to recruit and activate myeloid cells.
Activated myeloid cells initiate a positive feedback loop by
releasing cytokines and chemokines, chemical signals that attract
other immune cells and lower the activation threshold for an immune
response. This increases the population of activated immune system
cells in the tumor microenvironment and promotes a robust immune
response with the goal of generating durable therapeutic responses
for patients with cancer.
About Bolt Biotherapeutics, Inc.
Bolt Biotherapeutics is a clinical-stage biopharmaceutical
company developing novel immunotherapies for the treatment of
cancer. Bolt Biotherapeutics’ pipeline candidates are built on the
Company’s deep expertise in myeloid biology and cancer drug
development. The Company’s pipeline includes BDC-1001, a
HER2-targeting Boltbody™ Immune-Stimulating Antibody Conjugate
(ISAC); BDC-3042, a myeloid-modulating antibody; and multiple
Boltbody ISAC collaboration programs. BDC-1001 is currently in
Phase 2 clinical development following the successful completion of
a Phase 1 dose-escalation trial that demonstrated tolerability and
early clinical efficacy. BDC-3042, an agonist antibody targeting
Dectin-2, is expected to initiate a Phase 1 trial in the second
half of 2023. In preclinical development, BDC-3042 demonstrated the
ability to convert tumor-supportive macrophages to
tumor-destructive macrophages. Bolt Biotherapeutics is also
developing multiple Boltbody™ ISACs in strategic collaborations
with leading biopharmaceutical companies. For more information,
please visit https://www.boltbio.com/
Forward-Looking Statements
This 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 the advancement and success of our clinical
trials, the potential profile of BDC-1001, and the commencement of
future clinical trials, are forward-looking statements. In some
cases, you can identify forward-looking statements because they
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represent our current beliefs, estimates and assumptions only as of
the date of this press release and information contained in this
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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
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the reasons actual results could differ materially from those
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information becomes available in the future. Further information on
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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, 2022. 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:
Paige KellyStern Investor Relations,
Inc.212-362-1200paige.kelly@sternir.com
David Schull Russo Partners, LLC(858)
717-2310david.schull@russopartnersllc.com
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