TolerogenixX Completes Last Patient Transplant in Phase IIb TOL-2 Trial of MIC-Lx, Advancing a New Immune Tolerance Approach in Kidney Transplantation
- All 63 donor-recipient pairs enrolled and treated according to protocol across multiple clinical centers
- Randomized, controlled Phase IIb trial evaluating TolerogenixX’s proprietary MIC technology, a first-in-class immune tolerance-inducing cell therapy, in living-donor kidney transplantation
- Designed to address one of transplantation’s key issues: lifelong systemic immunosuppression
- Key milestone in the clinical development of MIC-Lx and TolerogenixX's proprietary MIC technology platform
Heidelberg, Germany, June 29, 2026. TolerogenixX, a clinical-stage biopharmaceutical company founded in 2016 developing personalized cell therapies to induce antigen-specific immune tolerance, today announced that the last patient has undergone kidney transplantation in TOL-2, the Company’s randomized, controlled Phase IIb clinical trial evaluating MIC-Lx in living-donor kidney transplantation (ClinicalTrials.gov identifier: NCT05365672 and EudraCT No.: 2021-000561-33).
Kidney transplantation saves lives, but patients typically need lifelong systemic immunosuppression. These drugs increase infection risk, add toxicity and create a major long-term treatment burden. MIC-Lx is designed to address this core limitation by teaching the immune system to accept the donor organ while preserving its protective immune function.
This milestone completes the transplantation phase of the TOL-2 study. TolerogenixX will publish topline efficacy and safety data in the first half of 2027.
A total of 63 donor-recipient pairs were enrolled and treated according to protocol across multiple clinical centers. Patients were randomized 2:1 to receive either MIC-Lx in addition to individualized immunosuppression (MIC group, n=42) or standard-of-care immunosuppression alone (control group, n=21).
The primary endpoint of TOL-2 assesses the achievement of an operational tolerance-like phenotype at day 367 following MIC-Lx administration. This endpoint measures the absence of biopsy-proven acute rejection, graft loss, graft dysfunction or death, as well as the absence of de novo donor-specific HLA antibodies. Secondary endpoints include patient-relevant infections, graft function, and additional immunological parameters.
“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,” said Prof. Dr. Matthias Schaier, CEO of TolerogenixX. “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 from donor-derived peripheral blood mononuclear cells (PBMCs), obtained by leukapheresis and modified via TolerogenixX’s proprietary MIC technology. The customized therapy is administered intravenously to transplant recipients prior to transplantation and is designed to induce donor-specific immune tolerance while preserving protective immune responses.
“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,” said Prof. Dr. Christian Morath, CSO of TolerogenixX. “This study addresses one of the key challenges in kidney transplantation, reducing the burden of lifelong immunosuppression without compromising graft protection.”
The TOL-2 study builds on findings from the previous TOL-1 Phase Ib trial, in which kidney transplant recipients treated with MIC-Lx showed long-term donor-specific immune tolerance signals, preserved graft function and reduced use of conventional immunosuppressive medication. All patients in the TOL-2 study will continue to be followed according to protocol, including a 12-month primary observation period and subsequent long-term follow-up.
The Company’s lead program focuses on living-donor kidney transplantation, with a planned expansion into additional transplant settings and selected autoimmune indications.
Beyond living-donor kidney transplantation, TolerogenixX is developing MIC-Lx as a potential immune tolerance platform covering additional transplant settings and selected autoimmune diseases, including systemic lupus erythematosus and multiple sclerosis.
MIC production is a standardized process designed for smart manufacturing and scalable roll-out. Using cells obtained by leukapheresis, MICs are manufactured through a proprietary process developed by TolerogenixX.
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About TolerogenixX
TolerogenixX is a privately held biopharmaceutical company developing novel, personalized therapies to induce antigen-specific immune tolerance in transplantation and autoimmune diseases. Its proprietary MIC (modified immune cells) technology aims to modulate the immune system in a targeted manner, potentially reducing the need for long-term systemic immunosuppression.
The Company’s lead candidate MIC-Lx has completed a Phase Ib clinical trial (TOL-1) in kidney transplant recipients demonstrating sustained safety and tolerability after a single administration while preserving normal immune responses. A Phase IIb study (TOL-2) is currently ongoing. TolerogenixX was founded in 2016 and is headquartered in Heidelberg, Germany.
About MIC treatment
MIC treatment is a personalized cell therapy approach to modulate the immune system via a novel mode of action to achieve specific and sustained immune tolerance. It could not only benefit transplant recipients, but also patients with autoimmune diseases such as systemic lupus erythematosus and multiple sclerosis.
MIC production is fast, safe, and effective. Using cells obtained by leukapheresis, MIC can be manufactured within 24 hours. Due to a standardized procedure, MIC production can be scaled up easily and made available globally using the proprietary approach developed by TolerogenixX.
Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding the expected timing of topline data from the TOL-2 study, the potential clinical benefits of MIC-Lx, future regulatory interactions, development plans, scale-up production, partnering opportunities and the broader potential of the MIC Platform. These statements are based on current expectations and involve risks and uncertainties. Actual results may differ materially from those expressed or implied by these forward-looking statements. TolerogenixX is under no obligation to update forward-looking statements except when required by applicable law.
Contact
TolerogenixX GmbH
Prof. Dr. med. Matthias Schaier Im Neuenheimer Feld 162 69120 Heidelberg
Germany schaier@tolerogenixX.com Tel. +49 162 2638005
akampion
Dr. Ludger Weß / Ines-Regina Buth Managing Partners info@akampion.com
Tel. +49 40 88 16 59 64
Tel. +49 30 23 63 27 68
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