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ACT-101 is a recombinant, non-glycosylated form of human alpha-fetoprotein (AFP), developed as an immunomodulatory therapy. It is being investigated primarily for autoimmune and inflammatory diseases, including myasthenia gravis, inflammatory bowel disease (Crohn’s/Colitis), multiple sclerosis, and thyroiditis. Mechanistically, ACT-101 modulates immune responses by reducing the production and activity of autoreactive T-cells and B-cells, increasing regulatory T-cell populations, desensitizing antigen-presenting cells to foreign antigens, binding to the neonatal Fc receptor (FcRn) to decrease autoantibody levels via interference with IgG recycling, promoting degradation of activated immune cells through caspase activation pathways, and stimulating myeloid-derived suppressor cells (MDSCs). The drug has demonstrated a strong safety profile in over 300 patients with no serious drug-related adverse events or neutralizing antibodies reported. It is administered subcutaneously once weekly[1][2][5][6].
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