Bolt Biotherapeutics announces U.S. FDA granted ODD for BDC-1001

Bolt Biotherapeutics announced that the U.S. Food and Drug Administration, FDA, granted Orphan Drug Designation, ODD, 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(TM) 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.”