BioNTech Achieves Major Oncology Breakthrough with Breast Cancer Treatment

BioNTech has reached a significant milestone in its return to cancer research, announcing positive results from a pivotal Phase 3 trial for a breast cancer therapy. This development marks the company’s first successful late-stage cancer study since its COVID-19 vaccine era and represents a strategic shift back toward its original oncology focus.

On September 5, 2025, BioNTech revealed that its experimental drug Trastuzumab Pamirtecan (BNT323/DB-1303) met the primary endpoint in a Phase 3 study involving HER2-positive breast cancer patients. The treatment, developed in partnership with DualityBio, demonstrated superior progression-free survival compared to standard therapies.

The trial enrolled 228 participants in China who had previously undergone multiple treatment regimens, representing a patient population with significant unmet medical needs. This achievement positions... Read more...