Elfetabart drozuntecan (BNT324/DB-1311)

Overview

A next-generation, topoisomerase-1-inhibitor-based antibody-drug conjugate targeting the immune-checkpoint protein B7-H3, co-developed with China's DualityBio - BioNTech's third late-stage oncology asset alongside BNT327 and trastuzumab pamirtecan, with clinical experience across more than ten tumor types.

First patient dosed in May 2026 in BNT324-03, a global pivotal Phase 3 trial (target enrollment 736 patients) versus docetaxel in taxane-naive metastatic castration-resistant prostate cancer (mCRPC), following a median radiographic progression-free survival of 11.3 months in heavily pretreated mCRPC patients. The FDA has granted the candidate Fast Track designation in mCRPC.

Key Specs