BioNTech, DualityBio receive FDA BTD for BNT323/DB-1303

BioNTech and Duality Biologics announced that the U.S. Food and Drug Administration, FDA, granted Breakthrough Therapy designation, BTD, for BNT323/DB-1303 for the treatment of advanced endometrial cancer in patients who progressed on or after treatment with immune checkpoint inhibitors. The designation is based on encouraging topline data from a Phase 1/2 study with BNT323/DB-1303 in patients with HER2-expressing advanced endometrial cancer. “The Breakthrough Therapy designation for BNT323/DB-1303 shows the potential of our ADC candidate to address current treatment challenges for patients with advanced HER2-expressing endometrial cancer who progressed under several lines of systemic therapy. For these patients the survival rates are still low and the medical need for new and more effective treatments remains high,” said Prof. Ozlem Tureci, M.D., Chief Medical Officer and Co-Founder at BioNTech. “With the designation and support by the FDA, we seek to expedite further development of BNT323/DB-1303.”