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M019 is a therapeutic recombinant immune complex (rIC) developed by Gliknik in collaboration with the University of Tennessee Health Science Center. It is designed to mimic the anti-inflammatory properties of intravenous immunoglobulin (IVIG) by targeting Fc gamma receptors, specifically CD16 (FcγRIII) and CD32 (FcγRII), on peripheral monocytes. In preclinical models of Multiple Sclerosis (MS), such as Experimental Autoimmune Encephalomyelitis (EAE), M019 has demonstrated the ability to inhibit the recruitment of autoreactive T cells and myeloid cells into the central nervous system (CNS). By modulating the activation state of monocytes and resident microglia, M019 reduces clinical disease severity, prevents demyelination, and lowers the expression of MHC II on antigen-presenting cells, thereby hindering the reactivation of T cells within the CNS.
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