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VIR-5818 is a bi-specific monoclonal antibody developed by Vir Biotechnology for the treatment of HER2-expressing solid tumors, including metastatic breast cancer and colorectal cancer. It is based on the XPAT (XTENylated Protease-Activated T Cell Engager) platform and functions as a protease-activated prodrug T-cell engager (TCE). The molecule comprises an XTEN polypeptide fused to single-chain variable fragments (scFv) targeting both HER2 and CD3, enabling selective activation of T cells in the tumor microenvironment. This dual-masked design aims to improve tolerability by limiting systemic immune activation while enhancing anti-tumor efficacy. VIR-5818 is administered intravenously and has shown promising early clinical activity with manageable safety in heavily pretreated patients with HER2-positive cancers[1][2][7].
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