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M5A-IL2 is an immunocytokine, a recombinant fusion protein that combines the tumor-targeting properties of the humanized anti-carcinoembryonic antigen (CEA; CEACAM5) monoclonal antibody (M5A) with the immune-stimulating activity of human interleukin 2 (IL‑2). The fusion is achieved by attaching IL‑2 to the C-terminal end of the heavy chain of the M5A antibody. This design enables selective delivery of IL‑2 to CEA-expressing tumor cells, thereby enhancing local immune activation and potentially reducing systemic toxicity. The mechanism involves targeting CEA-positive tumors—such as colorectal and breast cancers—and stimulating an anti-tumor immune response through activation and proliferation of T cells and natural killer cells at the tumor site. Preclinical studies have shown potent antitumor effects in models expressing human CEA, including induction of immune memory when combined with radiation therapy. Clinical trials are ongoing for unresectable metastatic colorectal cancer and CEA-positive metastatic breast cancer[1][4][5].
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