Bolt Biotherapeutics Announces First Patient Dosed in Phase 1/2 Study of BDC-3042 in Patients with Advanced Cancers
October 17 2023 - 6:00AM
Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage
biopharmaceutical company developing novel immunotherapies for the
treatment of cancer, today announced that the first patient has
been dosed with BDC-3042 in the single-agent dose-escalation
portion of this first-in-human Phase 1/2 clinical study. The study
will evaluate BDC-3042 in patients with metastatic or unresectable
triple-negative breast cancer (TNBC), colorectal cancer, clear cell
renal cell carcinoma, head and neck cancer, non-small cell lung
cancer (NSCLC), or ovarian cancer.
“We are excited to have dosed the first patient in this
first-in-human clinical trial, which will evaluate the safety,
pharmacokinetics, pharmacodynamics, and anti-tumor activity of
BDC-3042 in a diverse set of advanced cancers,” said Edith A.
Perez, M.D., Chief Medical Officer of Bolt Biotherapeutics.
“BDC-3042 is a monoclonal antibody that repolarizes
tumor-associated macrophages (TAMs) to attack tumor cells and is
the first-in-class Dectin-2 agonist. As Dectin-2 gene expression is
elevated in TAMs across a broad range of solid tumor types, we see
potential for this novel immunotherapy to be used for a wide range
of cancers. We are enthusiastic to advance our second innovative
immunotherapy program to the clinic with a focus on providing
breakthroughs for patients.”
“TAMs are a major component of the immune infiltrate in most
cancers and play a key role in establishing an immunosuppressive
tumor microenvironment that enables tumor progression,” explained
Shelley Ackerman, Ph.D., Director & BDC-3042 Preclinical
Project Team Lead. “In preclinical studies, BDC-3042 has shown the
ability to repolarize TAMs from a tumor-supportive to a
tumor-destructive phenotype.”
About the Phase 1 TrialThe Phase 1 trial
(NCT06052852) is a multi-center, open-label, dose-escalation and
dose-expansion study enrolling patients in the US with advanced
malignancies including triple-negative breast cancer, clear cell
renal cell carcinoma, colorectal cancer, head and neck cancer,
non-small cell lung cancer, and ovarian cancer. The study has four
parts. Part 1 is a dose escalation of BDC-3042 as a single agent to
determine the recommended Phase 2 dose (RP2D) for Part 3. In Part
3, the selected dose will be administered as monotherapy to
patients with selected advanced malignancies. Part 2 is a dose
escalation of BDC-3042 in combination with a checkpoint inhibitor
to determine the RPD2 for Part 4. In Part 4, the selected dose will
be administered in combination with a checkpoint inhibitor to
patients with select malignancies.
About BDC-3042Bolt Biotherapeutics’
myeloid-modulating antibody, BDC-3042, leverages the power of
myeloid cells to stimulate anti-tumor activity. It agonizes
Dectin-2, an immune-activating pattern recognition receptor
expressed by tumor-associated macrophages (TAMs) which are
frequently found in the tumor microenvironment. TAMs play a key
role in establishing an immunosuppressive tumor microenvironment
that is conducive to tumor survival and progression. By agonizing
Dectin-2, BDC-3042 activates TAMs to produce pro-inflammatory
cytokines and chemokines and repolarizes TAMs into
immunostimulatory macrophages. In addition, BDC-3042 induces
expression of key antigen presentation machinery, which helps to
expand tumor-reactive T cells and elicit anti-tumor immunity.
About Bolt Biotherapeutics, Inc.Bolt
Biotherapeutics is a clinical-stage biopharmaceutical company
leveraging the immune system for a better way to treat cancer. The
company is developing novel immunotherapies using an approach that
teaches the immune system to recognize and kill cancer in a way
that is immediately personalized to each patient. Its pipeline
candidates are built on the Company’s deep expertise in myeloid
biology and cancer drug development and include BDC-1001, a
HER2-targeting Boltbody™ Immune-Stimulating Antibody Conjugate
(ISAC) being evaluated in a Phase 2 trial, and BDC-3042, a
myeloid-modulating agonist antibody targeting Dectin-2, being
evaluated in a Phase 1 trial. 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
advancement and success of our clinical trials and any potential
future patent term extensions or adjustments, 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 demonstrate
the desired safety, potency or other product characteristics
described or assumed in this press release; and 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,
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
Bolt Biotherapeutics (NASDAQ:BOLT)
Historical Stock Chart
From May 2024 to Jun 2024
Bolt Biotherapeutics (NASDAQ:BOLT)
Historical Stock Chart
From Jun 2023 to Jun 2024