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VIR-5500 + docetaxel is an investigational combination regimen being evaluated for the treatment of advanced prostate cancer, including metastatic castration-resistant prostate cancer (mCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC). VIR-5500 (formerly AMX-500 or SAR446329) is a dual-masked, prostate-specific membrane antigen (PSMA)-targeted bispecific T-cell engager (TCE). It binds to PSMA on prostate cancer cells and CD3 on T cells, directing cytotoxic T-cell activity against the tumor. It incorporates the proprietary PRO-XTEN protease-cleavable masking technology, which is designed to keep the molecule inactive in systemic circulation and selectively activate it within the tumor microenvironment, minimizing off-tumor toxicities such as cytokine release syndrome. Docetaxel is a well-established taxane chemotherapy that binds to and stabilizes microtubules, preventing their depolymerization and disrupting mitosis. The combination is being co-developed by Vir Biotechnology and Astellas Pharma and is currently undergoing Phase 1 clinical evaluation.
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