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TOL-1 is a donor-derived cell therapy developed by TolerogenixX, utilizing the company's proprietary Modified Immune Cells (MIC) technology. The therapy is designed to induce donor-specific immunological tolerance in kidney transplant recipients, thereby preventing organ rejection and potentially reducing or eliminating the requirement for lifelong systemic immunosuppression. The production process involves harvesting peripheral blood mononuclear cells (PBMCs) from the organ donor and treating them ex vivo with a proprietary method involving mitomycin C to render them immunomodulatory. These modified cells are then intravenously administered to the transplant recipient prior to surgery. TOL-1 acts by suppressing the recipient's effector T-cell response and promoting the induction of regulatory T-cells (Tregs), creating a state of donor-specific hyporesponsiveness.
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