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Efdelikofusp alfa (GI-101A) is a novel bispecific immunocytokine designed to enhance anti-tumor immunity by simultaneously targeting the CTLA-4 and IL-2 pathways. It consists of the extracellular domain of human CD80 fused to an engineered interleukin-2 variant (IL-2v2) via an IgG4 Fc linker. The CD80 component acts as a checkpoint inhibitor by binding to CTLA-4 on T cells, thereby blocking immune suppression, and also binds to CD28 to provide co-stimulatory signals. The IL-2v2 component is engineered to have reduced affinity for the high-affinity IL-2 receptor alpha (CD25), which preferentially activates and expands CD8+ T cells and natural killer (NK) cells over immunosuppressive regulatory T cells (Tregs). Developed by GI Innovation, efdelikofusp alfa is being evaluated in clinical trials for the treatment of advanced solid tumors, both as a monotherapy and in combination with other immunotherapies like pembrolizumab.
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