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NI-1801 is a fully human IgG1 bispecific antibody that targets both mesothelin (MSLN), a tumor-associated antigen highly expressed in many solid tumors, and CD47, an immune checkpoint molecule. The antibody is designed with a high-affinity arm for MSLN and a low-affinity optimized arm for CD47, enabling selective blockade of CD47 on MSLN-expressing tumor cells while sparing normal cells. This unbalanced affinity allows for targeted immune activation against cancer cells. NI-1801 contains an unmodified IgG1 Fc region, which mediates effector functions such as antibody-dependent cellular phagocytosis (ADCP) and antibody-dependent cell-mediated cytotoxicity (ADCC) of MSLN-positive cancer cells. Preclinical studies have shown that NI-1801 inhibits tumor growth in xenograft models and demonstrates favorable pharmacokinetics and safety profiles in non-human primates. It is being developed primarily for the treatment of advanced or metastatic solid tumors expressing mesothelin, including ovarian cancer, pancreatic ductal adenocarcinoma, non-small cell lung cancer (NSCLC), and triple-negative breast cancer[6][4][7].
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