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VIR-5500 + Xtandi
- Development stage
- Unknown
- Lead developer
- Astellas Pharma
- Modality
- T-cell Engagers → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Small Molecules
- Administration
- Intravenous, Oral
01
Overview
VIR-5500 + Xtandi is an investigational combination regimen consisting of VIR-5500 (AMX-500) and enzalutamide (Xtandi). VIR-5500 is a dual-masked, prostate-specific membrane antigen (PSMA)-targeted T-cell engager (TCE) that utilizes the PRO-XTEN protease-cleavable masking technology to remain inactive in systemic circulation and selectively activate within the tumor microenvironment, thereby reducing off-target toxicities such as cytokine release syndrome. Enzalutamide is an approved oral androgen receptor pathway inhibitor (ARPI) that blocks androgen binding, nuclear translocation, and DNA binding. The combination is being co-developed by Vir Biotechnology and Astellas Pharma and is currently in Phase 1 clinical development (NCT05997615) for the treatment of advanced prostate cancer, including metastatic castration-resistant prostate cancer (mCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC).
- Other names
- AMX-500 + XtandiAMX-500 + enzalutamideVIR-5500 + enzalutamideXtandi + AMX-500Xtandi + VIR-5500enzalutamide + AMX-500enzalutamide + VIR-5500
02
Targets
AR (Adrenergic receptors)PSMA (Prostate-specific membrane antigen)CD3 (T-cell surface glycoprotein CD3)
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