BioNTech and DualityBio Receive FDA Fast Track Designation for Antibody-Drug Conjugate Candidate BNT324/DB-1311 in Prostate Cancer

Designation is based on pre-clinical data and data from an ongoing Phase 1/2 trial for BNT324/DB1311, with antitumor activity and a manageable safety profile demonstrated by preliminary Phase 1/2 clinical data from patients with advanced or metastatic solid tumors1,2 With the Fast Track designation, the development of BNT324/DB-1311 can benefit from more frequent engagement with the U.S. Food and Drug Administration ("FDA") to support development and expedite regulatory review Prostate cancer is the second ...