BioNTech, DualityBio Fast Tracked for Next-Generation Antibody-Drug Conjugate

 

• 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 cancer¹
• 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 type² with over 300,000 cases diagnosed globally each year³; 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

https://www.biospace.com/article/releases/biontech-and-dualitybio-receive-fda-fast-track-designation-for-next-generation-antibody-drug-conjugate-candidate-bnt325-db-1305/