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VIR-5500 + enzalutamide is an investigational combination regimen pairing VIR-5500 (also known as AMX-500) with enzalutamide (Xtandi). VIR-5500 is a prostate-specific membrane antigen (PSMA)-targeted, PRO-XTEN dual-masked CD3 T-cell engager (TCE). It is designed to bind PSMA on prostate cancer cells and CD3 on T cells, bringing them into proximity to facilitate T-cell-mediated tumor cell lysis. The PRO-XTEN masking technology keeps the TCE inactive in systemic circulation, preventing off-target toxicities like cytokine release syndrome (CRS), until tumor-associated proteases cleave the masks in the tumor microenvironment. Enzalutamide is an approved small-molecule androgen receptor pathway inhibitor. The combination is being co-developed by Vir Biotechnology and Astellas Pharma and is currently being evaluated in Phase 1 clinical trials (NCT05997615) for the treatment of early-line metastatic castration-resistant prostate cancer (mCRPC).
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