Posted by Michael Wonder on 25 Jun 2024
BioNTech and DualityBio receive FDA fast track designation for antibody-drug conjugate candidate BNT324/DB-1311 in prostate cancer
24 June 2024 - Designation is based on pre-clinical data and data from an ongoing Phase 1/2 trial for BNT324/DB-1311, with anti-tumour activity and a manageable safety profile demonstrated by preliminary Phase 1/2 clinical data from patients with advanced or metastatic solid tumours.
BioNTech and Duality Biologics today announced that the US FDA granted fast track designation for BNT324/DB-1311 for the treatment of patients with advanced/unresectable, or metastatic castration-resistant prostate cancer who have progressed on or after standard systemic regimens.
