BioNTech and partner DualityBio moved their B7-H3–targeting antibody–drug conjugate into a phase 3 trial for metastatic castration‑resistant prostate cancer (mCRPC) after encouraging phase 1/2 data, the companies said. The program is positioned against a competing Merck & Daiichi Sankyo ADC but aims to run a pivotal study roughly half the size of the rival program, a strategy that could shorten timelines and reduce costs if regulators accept the design. BioNTech is leveraging clinical efficacy signals to accelerate late‑stage testing in a crowded ADC field. The phase 3 launch reflects investor and partner appetite to back targeted cytotoxic payload delivery approaches in solid tumors; sources include company disclosures and industry reporting.