BioNTech and DualityBio Receive FDA Fast Track Designation for Next-Generation Antibody-Drug Conjugate Candidate BNT325/DB-1305

  Designation is based on preliminary safety and efficacy data from an ongoing Phase 1/2 trial in patients with platinum-resistant ovarian epithelial cancer, fallopian tube, or primary peritoneal cancer1Fast Track designation can facilitate the development and expedite the regulatory review of BNT325/DB-1305 Ovarian cancer is the fourth most common gynecological tumor type2 with over 300,000 cases diagnosed globally each year3; over 90% of ovarian tumors arise from epithelial cells, including the epithelia ...