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NI-0501 is a fully human monoclonal antibody discovered and developed by Novimmune as a potent inhibitor of IFNγ. Interferon-gamma (IFN-gamma or IFNγ) is a cytokine secreted by cells of the immune system to help regulate immune functions. Both the innate and adaptive immune systems use IFN-gamma to fight viral and intracellular bacterial infections. IFNγ is produced by natural killer (NK) and natural killer T (NKT) cells, as well as by CD4± and CD8± Cytotoxic T-lymphocyte (CTL) cells in response to specific pathogens. This particular cytokine is important to the immune system, in part, because it can directly inhibit the ability of viruses to replicate. It is also important as it helps to both stimulate as well as regulate other immune responses in the body, particularly inflammation. However, abnormal levels of IFNγ are associated with a number of autoinflammatory and autoimmune diseases including lupus, insulin-dependent diabetes, arthritis, and hemophagocytic lymphohistiocytosis, among others.

Inn NameEmapalumab
Lab CodesNI-0501
Chemical NameImmunoglobulin G1-lambda1, anti-[Homo sapiens IFNG (interferon gamma, IFN gamma)], Homo sapiens monoclonal antibody; gamma1 heavy chain (1-453) [Homo sapiens VH (IGHV3-23*01 -(IGHD) -IGHJ5*02) [8.8.16] (1-123) -IGHG1*03, Gm17,1 (CH1 (124-221), hinge (222-236), CH2 (237-346), CH3 (347-451), CHS (452-453)) (124-453)], (226-216')- disulfide with lambda1 light chain (1'-217') [Homo sapiens V-LAMBDA (IGLV6-57*01 (99.00%) -IGLJ3*02) [8.3.10] (1'-111') -IGLC2*01 (112'-217')]; dimer (232-232'':235-235'')-bisdisulfide
Alternate NameImmunoglobulin G1, anti-(human interferon gamma) (human monoclonal NI-0501 heavy chain), disulfide with human monoclonal NI-0501 light chain, dimer

Immunoglobulin G1-lambda1, anti-[homo sapiens ifng (interferon gamma, ifn gamma)], homo sapiens monoclonal antibody
Chemical StructureEmapalumab.png
Cas Registry Number1709815-23-5
Orphan Drug StatusYes
Orphan IndicationHaemophagocytic lymphohistiocytosis
New Molecular EntityYes
Mechanism Of ActionInterferon gamma inhibitor
Who Atc CodesL04 (Immunosuppressants)
Ephmra CodesL4 (Immunosuppressants)
IndicationHemophagocytic Lymphohistiocytosis

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