Bolt Biotherapeutics Announces First Patient Dosed in Phase 1/2 Study of BDC-3042 in Patients with Advanced Cancers

• BDC-3042, a novel Dectin-2 agonistic antibody that stimulates the innate immune system, is being evaluated in a Phase 1/2 dose-escalation and expansion study in patients with a broad range of solid tumors

REDWOOD CITY, Calif., Oct. 17, 2023 (GLOBE NEWSWIRE) -- 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 Trial

The 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-3042

Bolt 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 .

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