BERLIN (dpa-AFX) - Monday, BioNTech SE (BNTX) and Duality Biologics Co., Ltd. have announced that the FDA has granted Fast Track designation to BNT324/DB-1311 for treating patients with advanced or metastatic castration-resistant prostate cancer or CRPC, who have not responded to standard treatments.
The company stated that the Fast Track designation is supported by early safety and effectiveness data from an ongoing Phase 1/2 trial involving patients with advanced solid tumors.
BNT324/DB-1311 is an antibody-drug conjugate candidate that targets the B7-H3 immune checkpoint protein, which is linked to disease progression and poor patient outcomes.
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