Pharma BD Deal Intelligence
In April 2023 BioNTech and Duality Biologics (DualityBio) formed a global strategic partnership giving BioNTech development and commercialization rights (ex-Greater China) to two clinical-stage topoisomerase-1-inhibitor antibody-drug conjugates from DualityBio's DITAC platform: HER2-directed DB-1303 (BNT323) and B7-H3-directed DB-1311 (BNT324). DualityBio received $170M upfront plus up to ~$1.5B in development, regulatory and commercial milestones and tiered royalties (~$1.7B headline value). On August 7, 2023 the alliance was expanded to add a third ADC, the TROP2-directed DB-1305 (BNT325). The lead asset, DB-1303/BNT323 (INN trastuzumab pamirtecan, 'T-Pam'), has since de-risked materially: FDA granted Breakthrough Therapy Designation in advanced endometrial cancer (Dec 2023); the China Phase 3 DB-1303-O-3001 trial met its primary PFS endpoint in 2L HER2-positive metastatic breast cancer versus T-DM1 (Sep 2025); China's NMPA accepted a BLA for that indication (Apr 9, 2026); and a US FDA BLA in pretreated endometrial cancer is planned for later in 2026. The B7-H3 ADC DB-1311/BNT324 has advanced into a Phase 3 trial in metastatic castration-resistant prostate cancer (BNT324-03, vs docetaxel) and holds FDA Fast Track designation in mCRPC.