Bolt Biotherapeutics, Inc. announced that the first patient has been dosed in the Phase 2 clinical trial investigating BDC-1001, a HER2-targeting Boltbody?? Immune-Stimulating Antibody Conjugate (ISAC), as a single agent and in combination with the HER2-targeting antibody pertuzumab. The first patient was treated at City of Hope, by Irene Kang, M.D., Medical Director, Women's Health Medical Oncology, and Assistant Professor, Department of Medical Oncology and Therapeutics Research at City of Hope's cancer center in Irvine, California.

Preclinical research combining pertuzumab with a BDC-1001 surrogate demonstrated enhanced anti-tumor efficacy in multiple models and was originally reported in Ackerman SE, et al. Nat Cancer. 2021;2(1):18-33.

A full dataset was presented at the 38th Annual Meeting of the Society for Immunotherapy of Cancer in San Diego in November (Pearson C, et al. SITC 2023. Abstract #821), demonstrating that the combination significantly enhanced anti-tumor effectiveness in multiple HER2-expressing tumor models and providing a compelling mechanistic rationale for conducting a clinical trial to evaluate the potential benefit for patients.

Pertuzumab, which binds a distinct HER2 epitope from the trastuzumab component of BDC-1001, may increase the amount of clustered Fc or "eat me signals" on the surface of the tumor. 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 as described above.