Bolt Biotherapeutics Presents Updated Clinical Data from Phase 1 Dose-Escalation Trial of BDC-1001 as Monotherapy and in Combination with Nivolumab in HER2-Expressing Tumors at ESMO 2023 Congress
23 Octobre 2023 - 4:30PM
Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage
biopharmaceutical company developing novel immunotherapies for the
treatment of cancer, today presented updated data from its Phase 1
dose-escalation trial of BDC-1001 at the European Society for
Medical Oncology (ESMO) 2023 Congress, being held in Madrid, Spain
and virtually from October 20-24, 2023.
BDC-1001 is an investigational Immune-Stimulating Antibody
Conjugate (ISAC) in development for the treatment of patients with
human epidermal growth factor receptor 2 (HER2)-positive cancer.
BDC-1001 comprises a HER2-targeting biosimilar of trastuzumab
conjugated with a non-cleavable linker to a proprietary TLR7/8
agonist. The Phase 1 dose-escalation trial enrolled 131 patients
with 16 different HER2-expressing solid tumor types across 18 dose
levels in two arms, monotherapy and in combination with nivolumab.
At enrollment, all patients entered in the study had evidence of
tumor progression following prior standard of care treatments, and
a majority of the patients were heavily pre-treated.
“The encouraging updated Phase 1 dose escalation data of
BDC-1001 that was presented at ESMO further support the initiation
of our Phase 2 dose-expansion clinical trial in patients with
HER2-positive colorectal, breast, endometrial and gastric cancers,”
said Edith A. Perez, M.D., Chief Medical Officer of Bolt
Therapeutics. “We look forward to presenting initial data from the
Phase 2 dose-expansion trial in 2024.”
“The updated data from the Phase 1 dose-escalation study
continue to provide clinical validation of ISACs as a potential
therapeutic approach using BDC-1001 to treat patients with
HER2-expressing tumors,” said Bob T. Li., M.D., Ph.D., MPH, medical
oncologist, and principal investigator at Memorial Sloan Kettering
Cancer Center (MSK).
Key findings from the updated Phase 1 BDC-1001 dose escalation
study are summarized below.
- Improved BDC-1001 efficacy was observed since the data
presented at ASCO in June 2023 with one new CR, two additional
long-term SDs, and three patients who received therapy for at least
one year.
- At the RP2D, one CR was observed in the monotherapy arm in a
patient with salivary gland cancer and three PRs were observed at
the RP2D; one in the monotherapy arm in a patient with biliary
tract cancer and two in the combination arm in patients with
colorectal and ovarian cancer. The response rate at the RP2D was
29% in evaluable patients with HER2-positive tumors, both in
monotherapy (2/7, 29%) and in combination with nivolumab (2/7,
29%).
- At the RP2D, among evaluable patients with HER2-positive
tumors, 43% (3/7) in the monotherapy arm and 57% (4/7) in the
combination arm experienced at least 24 weeks of disease control,
and 57% (4/7) in the monotherapy arm and 71% (5/7) in the
combination arm achieved tumor shrinkage.
- BDC-1001 continues to be well tolerated at all dose levels and
schedules as both monotherapy and in combination with nivolumab
with no increase in toxicity in combination with BDC-1001. The most
frequent drug-related treatment-emergent adverse events (TEAEs)
were grade 1 or 2 infusion-related reactions, which were observed
in 29.8% of subjects. Grade 3 or higher treatment-related TEAEs
were seen in ten subjects (7.6%), with only one grade 4 and no
grade 5 drug-related AEs.
- Pharmacodynamic responses in both plasma and tissue were
consistent with the mechanism of action for an ISAC. Statistically
significant upregulation of TLR signaling pathway gene signature,
innate immunity gene signatures and T cell inflamed phenotype was
observed in the four patients with clinical benefit. Increases in
innate immunity signatures was observed in patients in the q2w
cohorts, but not q1w.
- The once-weekly dosing cohorts experienced higher rates of
adverse events versus every-two-week (q2w) dosing, including: grade
3 or higher BDC-1001-related TEAEs (10.0% versus 2.6%), grade 3 or
higher LVEF decreases (7.5% versus 2.6%), and infusion-related
reactions (40.0% versus 28.2%), providing further support for the
selection of 20 mg/kg q2w as the RP2D.
Details about the presentation can be found below and on the
ESMO website. Additionally, a copy of the presentation is available
on the Publications page of the Bolt Therapeutics website.
- Title: Recommended phase 2 dose (RP2D)
selection and pharmacodynamic (PD) data of the first-in-human
immune-stimulating antibody conjugate (ISAC) BDC-1001 in patients
(pts) with advanced HER2-expressing solid tumors
- Presenter: Bob Li, M.D., Ph.D., MPH, medical
oncologist, and principal investigator at MSK
- Presentation number: 657MO
- Presentation session: Developmental
therapeutics
- Details: Monday, October 23, 2023, 10:30 a.m.
– 12:00 p.m. EDT
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.
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 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/.
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Investor Relations and Media Contact:
Maeve ConneightonArgot Partners(212)
600-1902boltbio@argotpartners.com
Bolt Biotherapeutics (NASDAQ:BOLT)
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