Bolt Biotherapeutics' BDC-1001 Gets FDA Orphan Drug Designation To Treat Gastric Cancers

(RTTNews) - Bolt Biotherapeutics (BOLT), a clinical-stage biopharmaceutical company focused on cancer, announced Thursday that the U.S. Food and Drug Administration or FDA granted Orphan Drug Designation for BDC-1001 to treat gastric cancer, including gastroesophageal junction cancer.

Bolt's lead program, BDC-1001, is a Boltbody Immune-Stimulating Antibody Conjugate or ISAC in Phase 2 development for HER2-positive breast, colorectal, endometrial, and gastroesophageal cancers.

The Orphan Drug Designation is granted 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.

Edith Perez, Chief Medical Officer of Bolt Biotherapeutics, said, "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."

Bolt is now conducting two Phase 2 clinical trials in the U.S., Europe, and South Korea. The trial NCT04278144 is for patients with colorectal, endometrial, and gastroesophageal cancers and NCT05954143 is for patients with breast cancer.

For More Such Health News, visit rttnews.com