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This combination therapy consists of three agents: **sabatolimab** (MBG453), a monoclonal antibody targeting TIM-3 to reverse T-cell exhaustion and reinvigorate immune responses against leukemic stem cells; **NIS793**, a monoclonal antibody targeting transforming growth factor beta (TGF-β), designed to neutralize TGF-β’s immunosuppressive effects in the tumor microenvironment; and **decitabine**, a hypomethylating agent used to treat myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) by inducing DNA hypomethylation and promoting reactivation of silenced tumor suppressor genes. All three agents are being investigated as a multi-modality immunotherapy and epigenetic therapy regimen aiming to synergistically target malignant cells and their microenvironment, primarily in high-risk MDS and AML. - **Sabatolimab** is a high-affinity, humanized IgG4 monoclonal antibody targeting TIM-3, with immunomodulatory and anti-leukemic activity[2][3][5]. - **NIS793** is a human IgG2 monoclonal antibody directed at TGF-β, blocking a key pathway for tumor immune evasion[4]. - **Decitabine** is a cytidine analog inhibiting DNA methyltransferase, resulting in epigenetic modulation and increased immunogenicity of cancer cells[5][3].
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