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

CAR-T Digest - August 2020

24 June 2024: BioNTech and DualityBio Receive FDA Fast Track Designation for Antibody-Drug Conjugate Candidate BNT324/DB-1311 in Prostate Cancer

The U.S. FDA granted Fast Track designation for BNT324/DB-1311 for treating advanced or metastatic castration-resistant prostate cancer (CRPC), which has a 5-year survival rate of about 36%
This designation is based on preclinical and ongoing Phase 1/2 data (NCT05914116), demonstrating antitumor activity and a manageable safety profile
BNT324/DB-1311 is a next-generation ADC targeting the transmembrane glycoprotein B7-H3 with a topoisomerase-I inhibitor payload
The Fast Track designation allows more frequent FDA engagement to expedite development and review
All three clinical-stage ADCs in BioNTech and DualityBio’s collaboration have received FDA Fast Track designation, highlighting their ADC technology’s potential