Biontech and dualitybio receive fda breakthrough therapy designation for antibody-drug conjugate candidate bnt323/db-1303 in endometrial cancer

Mainz, germany and shanghai, china, december 21, 2023 –  biontech se  (nasdaq: bntx, “biontech”) and duality biologics (suzhou) co. ltd. (“dualitybio”) today announced that the u.s. food and drug administration (“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. bnt323/db-1303 is a next-generation antibody-drug conjugate (“adc”) candidate targeting the human epidermal growth factor receptor 2 (“her2”), a cell surface protein which is expressed in a range of tumor types. the designation is based on encouraging topline data from a phase 1/2 study ( nct05150691 ) with bnt323/db-1303 in patients with her2-expressing advanced endometrial cancer.
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