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VIR-5500 + darolutamide
- Development stage
- Unknown
- Lead developer
- Vir Biotechnology
- 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 + darolutamide is an investigational combination regimen consisting of VIR-5500 (also known as AMX-500), a masked, prostate-specific membrane antigen (PSMA)-targeted CD3 T-cell engager, and darolutamide (Nubeqa), an oral androgen receptor pathway inhibitor. VIR-5500 is a bispecific biologic designed with PRO-XTEN dual-masking technology, which keeps the T-cell engager inactive in systemic circulation until tumor-associated proteases cleave the masks in the tumor microenvironment, thereby reducing off-target toxicities. Darolutamide is a small molecule that competitively inhibits androgen binding to the androgen receptor, inhibiting receptor nuclear translocation and receptor-mediated transcription. The combination is being co-developed by Astellas and Vir Biotechnology and is currently being evaluated in a Phase 1 clinical trial (NCT05997615) for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC).
- Other names
- AMX-500 + darolutamideAMX-500 + NubeqaVIR-5500 + NubeqaVIR-5500 and darolutamideVIR5500 and darolutamideVIR 5500 and darolutamide
02
Targets
AR (Adrenergic receptors)CD3 (T-cell surface glycoprotein CD3)PSMA (Prostate-specific membrane antigen)
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