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Elfetabart drozuntecan (DB-1311/BNT324) is an investigational next-generation antibody-drug conjugate (ADC) targeting B7-H3 (CD276), a transmembrane glycoprotein immune checkpoint protein frequently overexpressed in solid tumors and associated with poor prognosis. Developed through a collaboration between BioNTech and DualityBio, the agent consists of a humanized monoclonal antibody conjugated to a potent topoisomerase-I inhibitor payload via a stable, cleavable linker. By binding to B7-H3 on the surface of tumor cells, the ADC is internalized, releasing the cytotoxic payload to induce DNA damage and apoptosis. Elfetabart drozuntecan is currently in Phase 3 development for metastatic castration-resistant prostate cancer (mCRPC) and is being investigated in Phase 2 trials for various other solid tumors, including lung, esophageal, and cervical cancers. The drug has received FDA Fast Track designation for prostate cancer and Breakthrough Therapy Designation in China for mCRPC.
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