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Immutol (also known as DCIL-10/Ag) is an investigational, second-generation tolerogenic cell and gene therapy designed to restore antigen-specific immune tolerance in patients with autoimmune diseases, primarily multiple sclerosis (MS). Developed under the EU-funded Horizon Europe IMMUTOL project, the therapy consists of autologous dendritic cells (DCs) differentiated in the presence of vitamin D3 (VitD3) and genetically engineered using a lentiviral vector to overexpress interleukin-10 (IL-10) and disease-specific immunodominant myelin antigens. This dual modification promotes the induction of antigen-specific regulatory T (Tr1) cells, which suppress pathogenic autoimmune responses without causing generalized immunosuppression. The program is currently in preclinical development, with efforts focused on optimizing GMP manufacturing and establishing clinical roadmaps for first-in-human trials.
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