BioNTech SE and Duality Biologics (Suzhou) Co. Ltd. announced that the U.S. Food and Drug Administration 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. BNT325 DB-1305 is a next-generation antibody-drug conjugate candidate targeting the trophoblast cell-surface antigen 2, a protein which is overexpressed on a range of tumor types.

The candidate is currently being evaluated in an ongoing Phase 1 2 study (NCT05438329) in patients with TROP2-expressing advanced solid tumors. Ovarian cancer is the fourth most common gynecological tumor type, 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 Ovarian epithelial cancer is often diagnosed at advanced disease stages, leading to a poor prognosis for patients. This makes it one of the most frequent causes of cancer death in women.3 The 5-year survival rate ranges from 26% to 42%, depending on the initial disease stage.