German biotechnology company BioNTech SE (NASDAQ: BNTC) and its partner Duality Biologics (Suzhou) Co., Ltd have received fast-track designation from the U.S. Food and Drug Administration for their jointly developed drug candidate DB-1305/BNT325. This designation is in recognition of the drug’s potential to treat platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer in patients who have received up to three prior lines of systemic treatment.
DB-1305 is a third-generation antibody drug conjugate (ADC) targeting Trop2, developed on Duality’s proprietary DITAC platform. The molecule has demonstrated potent anti-tumor activity in preclinical tumor models and has shown robust clinical efficacy in solid tumors, including non-small cell lung cancer. The strategic partnership between BioNTech and Duality, established in August 2023, granted BioNTech rights to develop, manufacture, and commercialize DB-1305 along with another HER2-targeted ADC from Duality’s pipeline. As part of this potential $1.67 billion deal, BioNTech made an upfront payment of $175 million, highlighting the significance of this collaboration.- Flcube.com
