Bolt Biotherapeutics to Present New Clinical Data from Completed Phase 1/2 Dose-Escalation Trial of BDC-1001 in HER2-Expressing Solid Tumors at the ESMO Congress 2023

REDWOOD CITY, Calif., Oct. 16, 2023 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics, Inc. (Nasdaq: BOLT), a clinical-stage biopharmaceutical company pioneering novel immuno-oncology therapeutics for the treatment of cancer, today announced that updated clinical data from its Phase 1/2 dose-escalation study of BDC-1001 will be presented in a mini-oral presentation at the European Society for Medical Oncology (ESMO) Congress 2023, 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. The ESMO presentation will include new results from the recently completed first-in-human Phase 1/2 dose-escalation study of BDC-1001 in patients with advanced HER2-expressing solid tumors.

“The upcoming presentation at ESMO builds on the positive data we presented at ASCO 2023 with additional insights into efficacy, safety, and biomarkers. These data provide further support for the recommended Phase 2 dose (RP2D) being used in the ongoing Phase 2 study of BDC-1001,” said Edith A. Perez, Chief Medical Officer of Bolt Biotherapeutics. “We are proud of the significant progress we have made with BDC-1001 and these latest data reinforce that Boltbody ISACs can activate a patient’s immune system to fight cancer. We continue to advance BDC-1001 through the Phase 2 clinical studies in four HER2-positive solid tumor types.”

Details about the presentation can be found below and on the ESMO 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 Memorial Sloan Kettering Cancer Center (MSK)
• Presentation Number: 657
• Time: Monday, October 23, 2023, 4:35 – 4:40 p.m. CET

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.