Biontech and dualitybio receive fda fast track designation for next-generation antibody-drug conjugate candidate bnt325/db-1305

Designation is based on preliminary safety and efficacy data from an ongoing phase 1/2 trial in patients with platinum-resistant ovarian epithelial cancer, fallopian tube, or primary peritoneal cancer 1 fast track designation can facilitate the development and expedite the regulatory review of bnt325/db-1305  ovarian cancer is the fourth most common gynecological tumor type 2 with over 300,000 cases diagnosed globally each year 3 ; over 90% of ovarian tumors arise from epithelial cells, including the epithelial tissue of the ovary, the lining of a fallopian tube or the peritoneum 4   mainz, germany and shanghai, china, january 31, 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 bnt325/db-1305 for the treatment of patients with platinum-resistant ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer who have received one to three prior systemic treatment regimens.
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