Biontech and dualitybio receive fda fast track designation for antibody-drug conjugate candidate bnt324/db-1311 in prostate cancer

Mainz, germany and shanghai, china, june 24, 2024 –  biontech se  (nasdaq: bntx, “biontech”) and duality biologics (suzhou) co., ltd. (“dualitybio”) today announced that the u.s. food and drug administration (“fda”) granted fast track designation for bnt324/db-1311 for the treatment of patients with advanced/unresectable, or metastatic castration-resistant prostate cancer (“crpc”) who have progressed on or after standard systemic regimens. bnt324/db-1311 is a next-generation antibody-drug conjugate (“adc”) candidate targeting the transmembrane glycoprotein b7-h3, an immune checkpoint protein which is overexpressed in a range of tumor types and has been associated with disease progression and poor prognosis for patients. the candidate is currently being evaluated in an ongoing phase 1/2 study ( nct05914116) in patients with advanced solid tumors.
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