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MER3101 is an investigational antigen-specific immunotherapeutic (ASI) vaccine developed for the prevention and treatment of Type 1 Diabetes (T1D). It consists of the insulin B chain (IBC) as the primary autoantigen, formulated with MAS-1, a proprietary nanoparticular, emulsion-based adjuvant. The therapy is designed to restore immune tolerance by shifting the immune response from a destructive pro-inflammatory Th1/Th17 profile toward a protective Th2 and regulatory T cell (Treg) response. Preclinical studies in NOD mice demonstrated that MER3101 induces the expansion of insulin-specific Tr1 and FoxP3+ regulatory T cells and increases the secretion of anti-inflammatory cytokines such as IL-10, IL-4, and IL-5. MER3101 is currently being evaluated in Phase 1 clinical trials to assess its safety, tolerability, and ability to preserve beta-cell function in patients with recently diagnosed T1D by favoring tolerogenic pathways to reverse autoimmunity.
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