Friday, September 29, 2023
Bolt Biotherapeutics, trading under the ticker symbol BOLT on Nasdaq, has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for their drug, BDC-1001. This designation is specifically for the treatment of gastric cancer, which includes gastroesophageal junction cancer.
Dr. Edith A. Perez, Chief Medical Officer of Bolt Biotherapeutics, highlighted the significance of this designation in addressing the needs of patients with gastric cancer. The company's Boltbody™ ISAC platform, currently undergoing clinical validation, holds substantial promise. They are actively advancing their Phase 2 program for BDC-1001, and beyond gastric cancer, they are also exploring its potential in three other cancer types: HER2-positive breast cancer, colorectal cancer, and endometrial cancer. The company is committed to making this innovative immunotherapy accessible to patients in need.
The FDA's Office of Orphan Products Development provides Orphan Drug Designation to drugs designed for treating rare diseases, offering several benefits to developers, including market exclusivity for up to seven years following approval, assistance in the drug development process, tax credits for clinical development, and exemptions from certain FDA fees.
BDC-1001 is Bolt Biotherapeutics' flagship program, designed as a Human Epidermal Growth Factor Receptor 2 (HER2) ISAC (Immune-Stimulating Antibody Conjugate). It combines a HER2-targeting biosimilar of trastuzumab with a non-cleavable linker and a proprietary TLR7/8 agonist. Following the successful completion of a dose-escalation trial for HER2-expressing solid tumors, the company is now conducting Phase 2 clinical trials in the U.S., Europe, and South Korea. One trial, NCT04278144, focuses on colorectal, endometrial, and gastroesophageal cancers, while NCT05954143 is for breast cancer patients.
Bolt Biotherapeutics' Boltbody ISAC platform combines the precision of antibodies with the power of the immune system to reshape the tumor microenvironment, triggering a robust anti-cancer response. Each Boltbody ISAC candidate consists of a tumor-targeting antibody, a non-cleavable linker, and a proprietary immune stimulant. The antibody targets markers on tumor cells, while the immune stimulant recruits and activates myeloid cells, initiating a positive feedback loop that enhances the immune response within the tumor microenvironment. This approach aims to generate long-lasting therapeutic responses for cancer patients.