Bolt Biotherapeutics, Inc. (Nasdaq: BOLT), a clinical-stage
biopharmaceutical company developing novel immunotherapies for the
treatment of cancer, today announced that the first patient has
been dosed in the Phase 2 clinical trial investigating BDC-1001, a
HER2-targeting Boltbody™ Immune-Stimulating Antibody Conjugate
(ISAC), as a single agent and in combination with the
HER2-targeting antibody pertuzumab.
The first patient was treated at City of Hope, one of the
largest cancer research and treatment organizations in the United
States, by Irene Kang, M.D., Medical Director, Women’s Health
Medical Oncology, and Assistant Professor, Department of Medical
Oncology and Therapeutics Research at City of Hope’s cancer center
in Irvine, California.
“The dosing of the first patient in this trial is a significant
achievement in our efforts to find new treatment options for
patients with HER2-positive breast cancer that continues to
progress after treatment,” said Kang, a principal investigator on
the study. “Despite the numerous HER2-targeted therapeutics
approved for treating advanced or metastatic HER2-positive breast
cancer, many patients ultimately have disease progression and new
options for treating these individuals are urgently needed.”
The addition of pertuzumab has been shown to improve anti-tumor
efficacy in preclinical models. The trial will treat patients with
HER2-positive metastatic breast cancer previously treated with
trastuzumab deruxtecan (Enhertu®).
“Patients with HER2-positive breast cancer who progress after
Enhertu have few therapeutic options,” said Edith A. Perez, M.D.,
Chief Medical Officer of Bolt Biotherapeutics. “BDC-1001 has a
unique mechanism of action compared to available agents, mobilizing
the patient’s immune system to fight cancer. This provides
scientific and clinical rationale for this new study. This is also
our first opportunity to clinically validate the compelling
anti-tumor activity we saw preclinically when combining BDC-1001
surrogate with pertuzumab.”
Bolt’s BDC-1001 Phase 2 program includes this trial with
BDC-1001 with or without pertuzumab in breast cancer, as well as
another trial in three additional HER2-positive tumor types. Both
trials utilize a Simon two-stage design. This multi-center,
randomized, 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 as
a single agent and in combination with pertuzumab. Roche is
providing pertuzumab in support of the trial. Please refer to
clinicaltrials.gov [NCT05954143] for additional information.
A poster detailing the trial design and rationale will also be
presented at the 2023 San Antonio Breast Cancer Symposium on
Wednesday, December 6, 2023. Details for the poster presentation
can be found below. Additionally, a copy of the poster will be
available on the Publications page of the Bolt Therapeutics website
at the start of the poster session.
Title: Phase 2 study of novel
HER2-targeting, TLR7/8 immune-stimulating antibody conjugate (ISAC)
BDC-1001 +/- pertuzumab in patients with HER2-positive metastatic
breast cancer (MBC) previously treated with trastuzumab
deruxtecan.Poster
Number: PO1-20-06Poster Session:
1Details: Wednesday, December 6, 2023, 12:00
p.m. – 2:00 p.m. CT
Preclinical research combining pertuzumab with a BDC-1001
surrogate demonstrated enhanced anti-tumor efficacy in multiple
models and was originally reported in Ackerman SE, et al. Nat
Cancer. 2021;2(1):18-33. A full dataset was presented at the 38th
Annual Meeting of the Society for Immunotherapy of Cancer in San
Diego in November (Pearson C, et al. SITC 2023. Abstract #821),
demonstrating that the combination significantly enhanced
anti-tumor efficacy in multiple HER2-expressing tumor models and
providing a compelling mechanistic rationale for conducting a
clinical trial to evaluate the potential benefit for patients.
Pertuzumab, which binds a distinct HER2 epitope from the
trastuzumab component of BDC-1001, may increase the amount of
clustered Fc or “eat me signals” on the surface of the tumor. This
is hypothesized to trigger enhanced antibody-dependent cellular
phagocytosis, a key element of the BDC-1001 mechanism of action,
resulting in further propagation of BDC-1001-driven immune
activation and anti-tumor efficacy.
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 in the U.S., Europe, and
South Korea: NCT04278144 for patients with colorectal, endometrial,
and gastroesophageal cancers and NCT05954143 for patients with
breast cancer as described above.
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 benefits of
combining BDC-1001 with pertuzumab, 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,” “on track,” “plan,”
“potential,” “predict,” “project,” “should,” “will,” or “would,” or
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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; and our ability to maintain our current
collaborations and establish further collaborations. 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, 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 Contact:
Maeve ConneightonArgot Partners(212)
600-1902boltbio@argotpartners.com
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