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REDWOOD CITY, Calif., Oct. 23, 2023 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics (NASDAQ:BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, today presented updated data from its Phase 1 dose-escalation trial of BDC-1001 at the European Society for Medical Oncology (ESMO) 2023 Congress, 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. BDC-1001 comprises a HER2-targeting biosimilar of trastuzumab conjugated with a non-cleavable linker to a proprietary TLR7/8 agonist. The Phase 1 dose-escalation trial enrolled 131 patients with 16 different HER2-expressing solid tumor types across 18 dose levels in two arms, monotherapy and in combination with nivolumab. At enrollment, all patients entered in the study had evidence of tumor progression following prior standard of care treatments, and a majority of the patients were heavily pre-treated.
"The encouraging updated Phase 1 dose escalation data of BDC-1001 that was presented at ESMO further support the initiation of our Phase 2 dose-expansion clinical trial in patients with HER2-positive colorectal, breast, endometrial and gastric cancers," said Edith A. Perez, M.D., Chief Medical Officer of Bolt Therapeutics. "We look forward to presenting initial data from the Phase 2 dose-expansion trial in 2024."
"The updated data from the Phase 1 dose-escalation study continue to provide clinical validation of ISACs as a potential therapeutic approach using BDC-1001 to treat patients with HER2-expressing tumors," said Bob T. Li., M.D., Ph.D., MPH, medical oncologist, and principal investigator at Memorial Sloan Kettering Cancer Center (MSK).
Key findings from the updated Phase 1 BDC-1001 dose escalation study are summarized below.
Details about the presentation can be found below and on the ESMO website. Additionally, a copy of the presentation is available on the Publications page of the Bolt Therapeutics website.
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.
About the Boltbody™ Immune-Stimulating Antibody Conjugate (ISAC) Platform
Bolt Biotherapeutics' Boltbody ISAC platform harnesses the precision of antibodies with the power of the innate and adaptive immune system to reprogram the tumor microenvironment to generate a productive anti-cancer response. Each Boltbody ISAC candidate comprises a tumor-targeting antibody, a non-cleavable linker and a proprietary immune stimulant. The antibody is designed to target one or more markers on the surface of a tumor cell, and the immune stimulant is designed to recruit and activate myeloid cells. Activated myeloid cells initiate a positive feedback loop by releasing cytokines and chemokines, chemical signals that attract other immune cells and lower the activation threshold for an immune response. This increases the population of activated immune system cells in the tumor microenvironment and promotes a robust immune response with the goal of generating durable therapeutic responses for patients with cancer.
Posted In: BOLT