Release Date: 25-Jan-2025
BNT326/YL202 is a next-generation antibody-drug conjugate (ADC) being jointly developed by BioNTech, a biotechnology company from Germany, and Bio-Thera, a biopharmaceutical firm located in China. This investigational agent specifically targets the Human Epidermal Growth Factor Receptor 3 (HER3), a protein that is often overexpressed in a variety of cancers. The formulation includes a monoclonal antibody that targets HER3, linked to a cytotoxic DNA topoisomerase I inhibitor via a protease-cleavable linker that becomes activated within the tumor microenvironment (TME). Following administration, the anti-HER3 antibody attaches to tumor cells expressing HER3, and subsequent proteolytic cleavage in the TME releases the topoisomerase I inhibitor. This inhibitor interacts with topoisomerase I, leading to DNA breaks, which disrupts DNA replication and triggers apoptosis in cancer cells.
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At present, BNT326/YL202 is undergoing clinical trials in China to evaluate its effectiveness as a treatment for cancers that exhibit HER3 overexpression. The trials focus on assessing its efficacy, safety, and the potential for enhanced outcomes in cancer treatment.