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MTX-201 is a bispecific antibody developed by Mozart Therapeutics designed to restore and potentiate the function of CD8 regulatory T cells (CD8 Treg) in highly inflammatory autoimmune diseases. It achieves this by simultaneously inhibiting killer cell immunoglobulin-like receptors (KIR), which act as inhibitory checkpoints on CD8 Treg, and activating the inducible T-cell costimulator (ICOS) receptor, which is critical for CD8 Treg activation. This dual mechanism selectively enhances the prevalence and cytolytic capacity of CD8 Tregs to eliminate pathogenic CD4 T cells while reducing proinflammatory cytokines and improving epithelial cell health. Preclinical studies have demonstrated that MTX-201 binds specifically to CD8 Tregs, does not activate other ICOS-expressing immune cells, reduces inflammation in models of inflammatory bowel disease (IBD), extends survival in acute graft-versus-host disease models, and shows acceptable tolerability in humanized mice[2][3][5][6].
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