BioNTech, DualityBio Fast Tracked for Antibody-Drug Conjugate Candidate in Prostate Cancer

 

• Designation is based on pre-clinical data and data from an ongoing Phase 1/2 trial for BNT324/DB-1311, with antitumor activity and a manageable safety profile demonstrated by preliminary Phase 1/2 clinical datafrom patients with advanced or metastatic solid tumors^1,2
• With the Fast Track designation,the development of BNT324/DB-1311 can benefit from more frequent engagement with the U.S. Food and Drug Administration (“FDA”) to support development and expedite regulatory review
• Prostate cancer is the second leading cause of cancer-related deaths among men worldwide³ often diagnosed at advanced disease stages; patients with metastatic castration–resistant prostate cancer (“mCRPC”), an advanced form of prostate cancer, have a 5-year survival rate of around 36%⁴
• All three clinical stage antibody-drug conjugate (“ADC”) candidates in BioNTech’s and DualityBio’s strategic collaboration have received FDA Fast Track designation supporting the potential of the companies’ ADC technology

https://www.biospace.com/article/releases/biontech-and-dualitybio-receive-fda-fast-track-designation-for-antibody-drug-conjugate-candidate-bnt324-db-1311-in-prostate-cancer/