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AU-007 + aldesleukin is a combination immunotherapy being developed by Aulos Bioscience for the treatment of advanced solid tumors. AU-007 is a computationally designed human IgG1 monoclonal antibody that binds to the CD25-binding epitope of interleukin-2 (IL-2). By binding to IL-2, AU-007 prevents the cytokine from interacting with the high-affinity trimeric IL-2 receptor (CD25/CD122/CD132) found on regulatory T cells (Tregs), vascular endothelium, and eosinophils. Crucially, it does not block IL-2 from binding to the dimeric IL-2 receptor (CD122/CD132) on effector T cells and natural killer (NK) cells. This mechanism redirects both endogenous and exogenous IL-2 (administered as low-dose aldesleukin) to promote anti-tumor immune responses while minimizing immunosuppression and toxicities like vascular leak syndrome. The combination is currently in Phase 1/2 clinical trials for various cancers, including melanoma and renal cell carcinoma.
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