Posted by Michael Wonder on 22 Dec 2023
BioNTech and DualityBio receive FDA breakthrough therapy designation for antibody drug conjugate candidate BNT323/DB-1303 in endometrial cancer
21 December 2023 - Designation is based on Phase 1/2 safety and efficacy data in patients with HER2 expressing advanced endometrial cancer with encouraging early signs of anti-tumour activity.
BioNTech and Duality Biologics today announced that the US FDA granted breakthrough therapy designation for BNT323/DB-1303 for the treatment of advanced endometrial cancer in patients who progressed on or after treatment with immune checkpoint inhibitors.
