Drug intelligence / Profile preview

VIR-5500 + Nubeqa

Development stage
Unknown
Lead developer
Bayer
Modality
T-cell Engagers → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Fc-Fusion Proteins → Carrier/Scaffold Proteins → Recombinant Proteins and Enzymes, Small Molecules
Administration
Intravenous, Oral
01

Overview

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).

Other names
AMX-500 + darolutamideAMX-500 + Nubeqadarolutamide + AMX-500darolutamide + SAR-446329darolutamide + SAR446329darolutamide + VIR-5500Nubeqa + AMX-500Nubeqa + SAR-446329Nubeqa + SAR446329Nubeqa + VIR-5500SAR-446329 + darolutamideSAR-446329 + NubeqaSAR446329 + darolutamideSAR446329 + NubeqaVIR-5500 + darolutamideVIR-5500 + Nubeqa
02

Targets

AR (Adrenergic receptors)PSMA (Prostate-specific membrane antigen)CD3 (T-cell surface glycoprotein CD3)

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