FDA Breakthrough Therapy Designation for Antibody-Drug Conjugate Candidate BNT323/DB-1303 in 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. Özlem Türeci, 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.”