Bolt Biotherapeutics Receives Orphan Drug Designation for BDC-1001 for Treatment of Gastric Cancers

• BDC-1001 is a Boltbody Immune-Stimulating Antibody Conjugate (ISAC) in Phase 2 development for HER2-positive breast, colorectal, endometrial, and gastroesophageal cancers
• The FDA granted BDC-1001 Orphan Drug Designation for the treatment of gastric cancer, including gastroesophageal junction cancer

REDWOOD CITY, Calif., Sept. 28, 2023 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for BDC-1001 for the treatment of gastric cancer, including gastroesophageal junction cancer.

“Receiving Orphan Drug Designation from the FDA is an important step forward in the development of BDC-1001 and reinforces the potential of BDC-1001 to address unmet needs for patients with gastric cancers,” said Edith A. Perez, M.D., Chief Medical Officer of Bolt Biotherapeutics. “Our Boltbody ISAC platform is the only one with emerging clinical validation, and we are working diligently to advance our ongoing Phase 2 program. In addition to gastric cancer, we are also evaluating BDC-1001 in three other tumor types with significant unmet medical need: HER2-positive breast, colorectal, and endometrial cancers. We look forward to advancing BDC-1001 in clinical development and bringing this novel immunotherapy to patients in need of further treatment options.”

The Office of Orphan Products Development of FDA grants Orphan Drug Designation to drugs and biologics intended for the treatment, diagnosis, or prevention of rare diseases, or conditions affecting fewer than 200,000 people in the United States. The designation affords Bolt the potential for certain benefits, including up to seven years of post-approval market exclusivity, assistance in the drug development process, tax credits for clinical development, and exemptions from certain FDA fees.

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.