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M5542 is an investigational biologic drug developed by Merck Healthcare KGaA for the treatment of T-cell-mediated autoimmune diseases. It is a fusion protein that combines CTLA4Ig and anti-OX40L, designed to modulate two key T-cell costimulatory pathways—CD28 and OX40—in a single molecule. This dual targeting approach aims to more efficiently control T-cell activation during inflammation than targeting each pathway separately. Preclinical data suggest potential utility in conditions such as graft-versus-host disease (GVHD) and other autoimmune disorders. The drug has undergone Phase 1 clinical trials to evaluate its safety, tolerability, immunogenicity, and pharmacokinetics in healthy volunteers; however, development is currently suspended[1][3][6][7].
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