22 Jan 2024: BioNTech and DualityBio initiate Phase 3 Trial for BNT323/DB-1303 in Metastatic Breast Cancer
BioNTech and DualityBio initiate pivotal Phase 3 trial for BNT323/DB-1303, targeting HER2 in metastatic breast cancer
The trial, following positive Phase 1/2 results, aims to enroll 532 patients globally, initially in China, followed by the US and EU for HR+ and HER2-low metastatic breast cancer
BNT323/DB-1303 is designed to minimize chemotherapy toxicity, with Phase 1/2 data demonstrating encouraging anti-tumor activity and a manageable safety profile
The strategic collaboration between BioNTech and DualityBio aims to advance the next-generation ADC candidate into late-stage development for various high unmet medical needs cancer indications