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BioNTech and DualityBio Receive FDA Fast Track Designation for Antibody-Drug Conjugate Candidate BNT324/DB-1311 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 data from patients with advanced or metastatic solid tumors 1 , 2 With the Fast Track
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 data from 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 worldwide 3 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 BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Biotheus, Duality Biologics, Fosun Pharma, Genentech, a member of the Roche Group, Genevant, Genmab, MediLink, OncoC4, Pfizer and Regeneron. Building upon deep understanding of disease biology and translational capability, DualityBio has advanced four assets into global clinical studies, and developed more than 10 innovative product candidates which are currently in preclinical stage.
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