BioNTech and Duality announce FDA Fast track designation for BNT325/DB-1305

BioNTech and Duality Biologics announced that the FDA granted Fast Track designation for BNT325/DB-1305 for the treatment of patients with platinum-resistant ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer who have received one to three prior systemic treatment regimens. BNT325/DB-1305 is a next-generation antibody-drug conjugate, or ADC, candidate targeting the trophoblast cell-surface antigen 2, or TROP2, a protein which is overexpressed on a range of tumor types. The candidate is currently being evaluated in an ongoing Phase 1/2 study in patients with TROP2-expressing advanced solid tumors. Ovarian cancer is the fourth most common gynecological tumor type, with over 300,000 cases diagnosed globally each year. Fast Track is a process designed to facilitate the development and expedite the review, of new drugs and vaccines that are intended to treat or prevent serious conditions that have the potential to address an unmet medical need.