By: IPP Bureau
Last updated : July 03, 2026 7:51 am
The clinical-stage biotech has completed the transplantation phase of its TOL-2 study evaluating MIC-Lx, with topline efficacy and safety data expected in the first half of 2027
TolerogenixX, a German clinical-stage biopharmaceutical company, has completed the transplantation phase of its Phase IIb TOL-2 clinical trial evaluating MIC-Lx, a personalised cell therapy designed to induce donor-specific immune tolerance in living-donor kidney transplantation.
The company announced that the last patient has undergone kidney transplantation, marking a key milestone in the study.
Kidney transplant recipients typically require lifelong immunosuppressive therapy to prevent organ rejection. While effective, these medicines increase the risk of infections, toxicity, and other long-term complications. MIC-Lx has been developed to train the recipient's immune system to accept the donor organ while preserving normal immune function, potentially reducing dependence on long-term systemic immunosuppression.
The TOL-2 study enrolled 63 donor-recipient pairs across multiple clinical centres. Participants were randomised in a 2:1 ratio, with 42 patients receiving MIC-Lx alongside individualised immunosuppressive therapy and 21 patients receiving standard-of-care immunosuppression alone.
The study's primary endpoint assesses the achievement of an operational tolerance-like phenotype 367 days after MIC-Lx administration, measured by the absence of biopsy-proven acute rejection, graft loss, graft dysfunction, death, and the development of donor-specific HLA antibodies. Secondary endpoints include graft function, infection rates, and other immunological outcomes.
The company expects to report topline efficacy and safety results from the Phase IIb trial during the first half of 2027.
Prof. Dr. Matthias Schaier, Chief Executive Officer of TolerogenixX, said, "The completion of the last patient transplant in TOL-2 puts TolerogenixX on a clear pathway towards one of the most important clinical readouts in immune tolerance. With all 63 donor-recipient pairs treated according to protocol, we believe MIC-Lx has the potential to transform transplant immunotherapy. This milestone strengthens our clinical, regulatory and partnering pathway as we prepare for topline Phase IIb data in H1 2027."
MIC-Lx is manufactured using donor-derived peripheral blood mononuclear cells obtained through leukapheresis and modified using TolerogenixX's proprietary MIC technology. The personalised therapy is administered intravenously before transplantation to promote donor-specific immune tolerance while maintaining protective immune responses.
Prof. Dr. Christian Morath, Chief Scientific Officer of TolerogenixX, said, "TOL-2 was designed to test whether MIC-Lx can reproduce the donor-specific immune tolerance signals observed in TOL-1 within a randomized, controlled Phase IIb setting. This study addresses one of the key challenges in kidney transplantation, reducing the burden of lifelong immunosuppression without compromising graft protection."