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AMY109 is a next-generation bispecific monoclonal antibody designed as a T-cell engager, developed by Chugai Pharmaceutical. It simultaneously targets Glypican-3 (GPC3), a cell-surface oncofetal antigen frequently overexpressed in hepatocellular carcinoma (HCC) and other solid tumors, and the CD3 subunit of the T-cell receptor complex. By bridging GPC3-expressing cancer cells with cytotoxic T cells, AMY109 facilitates the formation of an immunological synapse, leading to T-cell activation and the subsequent lysis of the tumor cells. AMY109 utilizes Chugai's proprietary antibody engineering technologies, such as ACT-Ig, which are intended to optimize the safety profile by potentially reducing the risk of cytokine release syndrome (CRS) while maintaining potent anti-tumor activity. It is currently being evaluated in Phase I clinical trials, both as a monotherapy and in combination with the PD-L1 inhibitor atezolizumab, for patients with advanced or recurrent solid tumors.
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