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Etakafusp alfa is a novel CD8+ T cell-selective interleukin-2 (IL-2) immunotherapy designed to maximize IL-2 activity on CD8+ T cells while minimizing activation of regulatory T cells (Tregs) and natural killer (NK) cells. It is a recombinant fusion protein generated by fusing a reduced-potency IL-2 mutein to an anti-CD8β antibody. This engineering enables potent and selective activation of CD8+ T lymphocytes—key drivers of anti-tumor immunity—while avoiding the pharmacological sink effect and toxicity associated with NK cell activation and the immunosuppressive effects mediated by Tregs. Etakafusp alfa is being developed as both monotherapy and in combination with other immuno-oncology agents for the treatment of solid tumors, including melanoma, renal cell carcinoma (RCC), non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and squamous cell carcinoma of the head and neck (SCCHN). Early clinical data demonstrate robust selectivity for CD8+ T cells with evidence of anti-tumor activity and favorable tolerability[1][3][4][5][6].
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