Drug intelligence / Profile preview

imneskibart + aldesleukin + nivolumab

Development stage
Phase 2
Lead developer
Aulos Bioscience, Inc.
Modality
Cytokines & Interferons → Recombinant Proteins and Enzymes, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous, Subcutaneous
01

Overview

Imneskibart + aldesleukin + nivolumab is an investigational triplet immunotherapy regimen being developed by Aulos Bioscience for the treatment of advanced solid tumors, specifically checkpoint inhibitor-refractory cutaneous melanoma. The regimen combines imneskibart (AU-007), a human IgG1 monoclonal antibody designed with artificial intelligence to bind to the CD25-binding portion of interleukin-2 (IL-2); aldesleukin (Proleukin), a recombinant human IL-2; and nivolumab (Opdivo), an anti-PD-1 checkpoint inhibitor. Imneskibart selectively redirects both endogenous and exogenous IL-2 (aldesleukin) away from immunosuppressive regulatory T cells (Tregs) and toward CD8+ effector T cells and natural killer (NK) cells, thereby enhancing anti-tumor immune responses while minimizing IL-2-associated toxicities like vascular leak syndrome. Nivolumab further enhances this immune response by blocking the PD-1 pathway. In clinical trials, this triplet regimen has demonstrated encouraging anti-tumor activity and a manageable safety profile in heavily pretreated patients.

Other names
AU-007 + IL-2 + OpdivoAU-007 + IL-2 + nivolumabAU-007 + aldesleukin + OpdivoAU-007 + aldesleukin + nivolumabimneskibart + IL-2 + Opdivoimneskibart + IL-2 + nivolumabimneskibart + aldesleukin + Opdivo
02

Targets

IL-2 (Interleukin 2)IL2RB (IL-2 receptor beta chain)IL2RG (Interleukin-2 receptor gamma subunit)PDCD1 (Programmed cell death protein 1 receptor)

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