FDA Fast Track for BioNTech & DualityBio’s Next-Gen ADC BNT325/DB-1305

CAR-T Digest - August 2020

31 Jan 2024: FDA Fast Track Designation for BioNTech & DualityBio’s Next-Gen ADC BNT325/DB-1305

BioNTech and DualityBio have received FDA Fast Track designation for their next-generation antibody-drug conjugate (ADC) BNT325/DB-1305, targeting platinum-resistant ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer in heavily pretreated patients with TROP2-expressing solid tumors
BNT325/DB-1305 addresses the unmet medical need for effective treatments in platinum-resistant cases. The FDA Fast Track designation is based on promising preliminary data from an ongoing Phase 1/2 trial showing encouraging anti-tumor signals in patients with TROP2-expressing solid tumors
Encouraging data from the Phase 1/2 trial, with an objective response rate of 30.4% and a disease control rate of 87.0%, supports the Fast Track development
BNT325/DB-1305, a third-generation ADC targeting TROP2, is part of the strategic collaboration between BioNTech and DualityBio, showcasing potential in addressing unmet medical needs and improving outcomes for patients