Bolt Biotherapeutics Initiates Phase 2 Clinical Studies of BDC-1001 in Patients With HER2-Positive Cancer

• BDC-1001 is a Boltbody™ Immune-Stimulating Antibody Conjugate (ISAC) in development for HER2-positive breast, colorectal, endometrial, and gastroesophageal cancers
• BDC-1001 administered to initial patients in Phase 2 dose-expansion cohorts

Excerpt from the Press Release:

REDWOOD CITY, Calif., Aug. 03, 2023 (GLOBE NEWSWIRE) — Bolt Biotherapeutics, Inc. (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, today announced that the first patients have been dosed in a Phase 2 dose-expansion clinical trial investigating BDC-1001, a HER2-targeting Boltbody™ Immune-Stimulating Antibody Conjugate (ISAC). The trial will explore BDC-1001 monotherapy treatment in three discreet cohorts for patients with HER2-positive colorectal, endometrial and gastroesophageal cancers.

“This is an important milestone for our company that builds on the positive signal of monotherapy activity that we observed in the Phase 1 portion of the study,” said Edith A. Perez, M.D., Chief Medical Officer of Bolt Biotherapeutics. “Despite considerable advances in anti-cancer therapy, HER2-positive tumors remain difficult to treat, and new therapeutic options are urgently needed. Our ISAC platform brings a novel mechanism with the potential to address refractory and recurrent disease to the treatment of HER2+ cancers and BDC-1001 has demonstrated promise. We are committed to advancing this study for the benefit of the many patients in need.”

Bolt’s BDC-1001 Phase 2 program includes discrete cohorts across four different HER2-positive tumor types and utilizes a Simon two-stage design with the aim of replicating the approximately 30% objective response rate previously demonstrated in the Phase 1 study. The Phase 2 dose-expansion trial is initially investigating BDC-1001 as a monotherapy in each of the three separate cohorts (HER2-positive colorectal, endometrial, and gastroesophageal cancer). This multi-center, open-label Phase 2 trial will evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of BDC-1001 administered intravenously at 20 mg/kg every other week (q2w). Please refer to clinicaltrials.gov [NCT04278144] for additional information.

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