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VIR-5500 + Nubeqa is an investigational combination regimen consisting of VIR-5500 (also known as AMX-500 or SAR-446329) and Nubeqa (darolutamide). VIR-5500 is a prostate-specific membrane antigen (PSMA)-targeted, PRO-XTEN dual-masked T-cell engager (TCE) designed to bind PSMA on prostate cancer cells and CD3 on T cells. The PRO-XTEN masking technology keeps the TCE inactive in systemic circulation, with activation occurring selectively in the tumor microenvironment via cleavage by tumor-associated proteases, thereby minimizing systemic toxicities such as cytokine release syndrome (CRS). Nubeqa (darolutamide) is an oral, non-steroidal androgen receptor inhibitor that competitively inhibits androgen binding, receptor nuclear translocation, and receptor-mediated transcription. The combination is being evaluated in a Phase 1 clinical trial for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).
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