BDC-3042 was well tolerated up to 10 mg/kg q2w with no dose-limiting toxicities and no drug-related serious adverse events
BDC-3042 showed biological activity, with clear dose-dependent increases in proinflammatory cytokines and chemokines
BDC-3042 showed signs of anti-tumor activity, including an unconfirmed partial response, stable disease ≥ 12 weeks in 3/3 non-small cell lung cancer patients and in 2/3 patients at the highest dose
Bolt is running a partnering process to advance development of BDC-3042
REDWOOD CITY, CA, USA I April 25, 2025 I Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, today announced results from its Phase 1 dose-escalation clinical study of BDC-3042 at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 25-30, 2025, in Chicago, Illinois.
“We are excited about the potential of BDC-3042 to help patients with cancer. This initial dose-escalation study demonstrated a favorable safety profile, dose-dependent biologic activity, and monotherapy anti-tumor activity,” said Willie Quinn, Chief Executive Officer. “BDC-3042 deserves rapid development, especially given its enormous commercial potential. We are launching a process to find a partner with the resources to accelerate development and optimize commercialization.”
BDC-3042 is a proprietary agonist antibody that targets dectin-2, an immune-activating receptor expressed by tumor-associated macrophages (TAMs). Dectin-2 is a C-type lectin receptor best known for its role in pathogen recognition and induction of protective immune responses against fungi and other microbes. This single-agent, dose-escalation Phase 1 clinical study is evaluating BDC-3042 in patients with metastatic or unresectable triple-negative breast cancer (TNBC), clear cell renal cell carcinoma (ccRCC), colorectal cancer (CRC), melanoma, non-small cell lung cancer (NSCLC), and ovarian cancer.
Key Clinical Study Findings:
Seventeen patients with six different tumor types and a median of four prior lines of therapy were enrolled across the seven dose cohorts. As of the April 7, 2025 data cut-off, results showed:
- BDC-3042 was well tolerated up to the highest dose level tested (10 mg/kg q2w), with no dose-limiting toxicities observed. Across all dose cohorts:
- No grade 4 or 5 drug-related adverse events (AEs) were reported
- No drug-related serious adverse events (SAEs) were reported
- No drug-related treatment discontinuations
- The most frequent drug-related AEs were fatigue (12%), flatulence (12%), and nausea (12%)
- BDC-3042 demonstrated favorable pharmacokinetics (PK) providing ample exposure and flexibility to widen the dosing interval
- Biological activity was confirmed, with evidence of target engagement and peripheral immunostimulatory effects consistent with preclinical studies
- 100% (5/5) of patient samples had detectable dectin-2 staining when assessed by immunohistochemistry (IHC)
- The study provided evidence of monotherapy anti-tumor activity
- One NSCLC patient from the 10 mg/kg cohort had an unconfirmed partial response and remains on study beyond 18 weeks
- 80% of evaluable patients (12/15) had SD or better as their best response
- Four out of five patients who had progressed after previous treatment with PD-1/PD-L1 blockers had SD with some reduction in tumor size
- All three NSCLC patients had SD or better with some reduction in tumor size
The dose-escalation data support the selection of 10 mg/kg q2w as a recommended Phase 2 dose (RP2D), alongside potential exploration of other doses and schedules. The results support further clinical development in NSCLC and other post-immunotherapy settings, as patients previously treated with PD-(L)1 inhibitors appear to have more dectin-2 expression and may experience improved outcomes.
“BDC-3042 demonstrated a very favorable safety profile across all seven dose levels in a late-line patient population that is difficult to treat,” said Ecaterina Dumbrava, M.D., associate professor of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center. “The favorable safety, PK, and immunostimulatory effects of BDC-3042 support its further study in selected indications and underscore its combination potential with immune checkpoint inhibitors and other therapies.”
Details about the poster presentations can be found on the AACR website. Additionally, a copy of each poster is available on the Publications page of the Bolt Biotherapeutics website.
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-3042, a first-in-class agonist antibody that activates macrophages by targeting dectin-2, and BDC-4182, a next-generation Boltbody™ Immune-Stimulating Antibody Conjugate (ISAC) clinical candidate targeting claudin 18.2. BDC-3042 is currently in a Phase 1 dose-escalation trial that includes patients with any of seven different solid tumor types. BDC-4182 is supported by strong in vitro and in vivo data demonstrating potent anti-tumor activity, and activities are underway to support the initiation of clinical trials in second quarter 2025. Bolt Biotherapeutics is also developing additional Boltbody™ ISACs in strategic collaborations with leading biopharmaceutical companies. For more information, please visit https://www.boltbio.com/.
SOURCE: Bolt Biotherapeutics
Post Views: 936
BDC-3042 was well tolerated up to 10 mg/kg q2w with no dose-limiting toxicities and no drug-related serious adverse events
BDC-3042 showed biological activity, with clear dose-dependent increases in proinflammatory cytokines and chemokines
BDC-3042 showed signs of anti-tumor activity, including an unconfirmed partial response, stable disease ≥ 12 weeks in 3/3 non-small cell lung cancer patients and in 2/3 patients at the highest dose
Bolt is running a partnering process to advance development of BDC-3042
REDWOOD CITY, CA, USA I April 25, 2025 I Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, today announced results from its Phase 1 dose-escalation clinical study of BDC-3042 at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 25-30, 2025, in Chicago, Illinois.
“We are excited about the potential of BDC-3042 to help patients with cancer. This initial dose-escalation study demonstrated a favorable safety profile, dose-dependent biologic activity, and monotherapy anti-tumor activity,” said Willie Quinn, Chief Executive Officer. “BDC-3042 deserves rapid development, especially given its enormous commercial potential. We are launching a process to find a partner with the resources to accelerate development and optimize commercialization.”
BDC-3042 is a proprietary agonist antibody that targets dectin-2, an immune-activating receptor expressed by tumor-associated macrophages (TAMs). Dectin-2 is a C-type lectin receptor best known for its role in pathogen recognition and induction of protective immune responses against fungi and other microbes. This single-agent, dose-escalation Phase 1 clinical study is evaluating BDC-3042 in patients with metastatic or unresectable triple-negative breast cancer (TNBC), clear cell renal cell carcinoma (ccRCC), colorectal cancer (CRC), melanoma, non-small cell lung cancer (NSCLC), and ovarian cancer.
Key Clinical Study Findings:
Seventeen patients with six different tumor types and a median of four prior lines of therapy were enrolled across the seven dose cohorts. As of the April 7, 2025 data cut-off, results showed:
- BDC-3042 was well tolerated up to the highest dose level tested (10 mg/kg q2w), with no dose-limiting toxicities observed. Across all dose cohorts:
- No grade 4 or 5 drug-related adverse events (AEs) were reported
- No drug-related serious adverse events (SAEs) were reported
- No drug-related treatment discontinuations
- The most frequent drug-related AEs were fatigue (12%), flatulence (12%), and nausea (12%)
- BDC-3042 demonstrated favorable pharmacokinetics (PK) providing ample exposure and flexibility to widen the dosing interval
- Biological activity was confirmed, with evidence of target engagement and peripheral immunostimulatory effects consistent with preclinical studies
- 100% (5/5) of patient samples had detectable dectin-2 staining when assessed by immunohistochemistry (IHC)
- The study provided evidence of monotherapy anti-tumor activity
- One NSCLC patient from the 10 mg/kg cohort had an unconfirmed partial response and remains on study beyond 18 weeks
- 80% of evaluable patients (12/15) had SD or better as their best response
- Four out of five patients who had progressed after previous treatment with PD-1/PD-L1 blockers had SD with some reduction in tumor size
- All three NSCLC patients had SD or better with some reduction in tumor size
The dose-escalation data support the selection of 10 mg/kg q2w as a recommended Phase 2 dose (RP2D), alongside potential exploration of other doses and schedules. The results support further clinical development in NSCLC and other post-immunotherapy settings, as patients previously treated with PD-(L)1 inhibitors appear to have more dectin-2 expression and may experience improved outcomes.
“BDC-3042 demonstrated a very favorable safety profile across all seven dose levels in a late-line patient population that is difficult to treat,” said Ecaterina Dumbrava, M.D., associate professor of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center. “The favorable safety, PK, and immunostimulatory effects of BDC-3042 support its further study in selected indications and underscore its combination potential with immune checkpoint inhibitors and other therapies.”
Details about the poster presentations can be found on the AACR website. Additionally, a copy of each poster is available on the Publications page of the Bolt Biotherapeutics website.
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-3042, a first-in-class agonist antibody that activates macrophages by targeting dectin-2, and BDC-4182, a next-generation Boltbody™ Immune-Stimulating Antibody Conjugate (ISAC) clinical candidate targeting claudin 18.2. BDC-3042 is currently in a Phase 1 dose-escalation trial that includes patients with any of seven different solid tumor types. BDC-4182 is supported by strong in vitro and in vivo data demonstrating potent anti-tumor activity, and activities are underway to support the initiation of clinical trials in second quarter 2025. Bolt Biotherapeutics is also developing additional Boltbody™ ISACs in strategic collaborations with leading biopharmaceutical companies. For more information, please visit https://www.boltbio.com/.
SOURCE: Bolt Biotherapeutics
Post Views: 936
