FDA grants Orphan Drug Designation for BDC-1001 for Treatment of Gastric Cancers
“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.”
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