Bolt Biotherapeutics Receives Orphan Drug Designation for BDC-1001 for Treatment of Gastric Cancers
September 28 2023 - 7:00AM
Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage
biopharmaceutical company developing novel immunotherapies for the
treatment of cancer, today announced that the U.S. Food and Drug
Administration (FDA) granted Orphan Drug Designation for BDC-1001
for the treatment of gastric cancer, including gastroesophageal
junction cancer.
“Receiving Orphan Drug Designation from the FDA is an important
step forward in the development of BDC-1001 and reinforces the
potential of BDC-1001 to address unmet needs for patients with
gastric cancers,” said Edith A. Perez, M.D., Chief Medical Officer
of Bolt Biotherapeutics. “Our Boltbody™ ISAC platform is the only
one with emerging clinical validation, and we are working
diligently to advance our ongoing Phase 2 program. In addition to
gastric cancer, we are also evaluating BDC-1001 in three other
tumor types with significant unmet medical need: HER2-positive
breast, colorectal, and endometrial cancers. We look forward to
advancing BDC-1001 in clinical development and bringing this novel
immunotherapy to patients in need of further treatment
options.”
The Office of Orphan Products Development of FDA grants Orphan
Drug Designation to drugs and biologics intended for the treatment,
diagnosis, or prevention of rare diseases, or conditions affecting
fewer than 200,000 people in the United States. The designation
affords Bolt the potential for certain benefits, including up to
seven years of post-approval market exclusivity, assistance in the
drug development process, tax credits for clinical development, and
exemptions from certain FDA fees.
About BDC-1001Bolt 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.
About the Boltbody™ Immune-Stimulating Antibody
Conjugate (ISAC) PlatformBolt 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 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 the
ability of BDC-1001 to address unmet patient needs, the potential
for orphan drug designation to help with development, the benefits
afforded by orphan drug designation, and advancement and success of
our clinical trials, 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 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; 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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