• Extends proprietary immunoregulatory MIC platform into autoimmune disease
  • Tolerance-inducing approach designed to correct dysregulated immune responses rather than only suppress inflammation
  • Potential to reduce the long-term treatment burden associated with multi-drug immunosuppression

Heidelberg, Germany, November 11, 2026. TolerogenixX, a clinical-stage biopharmaceutical company developing personalized cell therapies to induce antigen-specific immune tolerance, today announced that a new study in Kidney International provides preclinical proof-of-concept for its Modified Immune Cells (MIC) platform in lupus nephritis, a severe manifestation of systemic lupus erythematosus (SLE).

The study demonstrates for the first time that MIC therapy can significantly ameliorate the course of lupus nephritis in an established in vivo mouse model. Treatment reduced disease progression and was associated with lower proteinuria, albuminuria, serum creatinine and anti-dsDNA autoantibody levels. In addition, MIC-treated animals showed reduced kidney inflammation, fibrosis and complement deposition compared with untreated controls.

The findings extend previous preclinical and clinical work with the MIC approach and support the potential of the platform in autoimmune indications beyond organ transplantation. The study was specifically designed to assess whether immunoregulatory effects observed in transplantation and previous autoimmune models could also be demonstrated in lupus nephritis.

MIC therapy is designed to induce immune tolerance using immune cells treated ex vivo with mitomycin C. In the lupus nephritis model, treatment was associated with increased regulatory-like B lymphocytes and reduced levels of several pro-inflammatory cytokines. The researchers also observed marked changes in kidney-resident tertiary lymphoid structures, including reduced organization of B- and T-cell areas and disruption of germinal centers involved in pathogenic autoantibody production.

Importantly, the immunological changes observed in the lupus model were similar to findings previously reported in clinical studies of MIC therapy in kidney transplantation, supporting the concept of a broader immunoregulatory mechanism across different immune-mediated settings.

“The findings show that the MIC approach has potential well beyond transplantation,” said Prof. Dr. Matthias Schaier, CEO of TolerogenixX and corresponding author of the study. “In this lupus nephritis model, we see both a clear effect on disease progression and immunological changes that are consistent with what we have observed in our transplantation program. This provides a strong scientific basis to further explore MIC therapy in autoimmune diseases.”

The study also included an in vitro analysis using cells from patients with lupus nephritis. Macrophages from lupus patients were able to clear autologous MIC at levels comparable with healthy controls, helping to address a potential translational concern for the approach. The authors conclude that the study represents an important step toward the clinical translation of MIC therapy in SLE.

“Our MIC approach differs fundamentally from many current lupus nephritis therapies. Rather than depleting a specific immune-cell population or blocking a single pathway, MIC therapy is designed to engage endogenous mechanisms of immune tolerance,” said Prof. Dr. Christian Morath, CSO of TolerogenixX. “In the new lupus nephritis study, treatment affected several components of the immune response, including regulatory-like B cells, pro-inflammatory cytokines and pathogenic tertiary lymphoid structures in the kidney. Importantly, similar immunoregulatory effects have previously been observed in our kidney transplantation program, supporting the broader platform potential of MIC beyond transplantation.”

TolerogenixX is also preparing a peer-reviewed publication reporting ten-year follow-up data from its kidney transplantation program, further extending the long-term clinical evidence generated with the MIC approach in transplantation.

“The combination of long-term clinical experience in kidney transplantation and emerging preclinical evidence in autoimmune disease is broadening the potential scope of our platform,” Schaier added. “Our goal is to build on this growing body of evidence and evaluate where MIC-induced immune tolerance can provide meaningful benefit to patients with immune-mediated diseases.”

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About the study
The study, “Modified immune cell therapy targets kidney-resident tertiary lymphoid structures and ameliorates murine lupus nephritis,” investigated MIC therapy in NZB/W F1 mice, an established model of lupus nephritis. Mice were treated with syngeneic splenocytes exposed to mitomycin C and followed for five weeks using clinical, histological, serological, and immunological parameters. The prespecified combined primary endpoint was reached significantly less frequently in both MIC-treated groups than in untreated controls.

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 is designed to modulate the immune system in a targeted manner, with the potential to reduce 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 designed to modulate the immune system through a novel mode of action and achieve specific, sustained immune tolerance. The approach has potential applications not only in transplantation but also in autoimmune diseases such as systemic lupus erythematosus and multiple sclerosis.

MIC manufacturing is designed as a rapid, standardized process. Using cells obtained by leukapheresis, MIC can be manufactured within 24 hours. The standardized process is designed to support scale-up and broader availability using TolerogenixX’s proprietary manufacturing approach.

 

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.

Contacts

TolerogenixX GmbH
Prof. Dr. med. Matthias Schaier
Im Neuenheimer Feld 162
69120 Heidelberg
Germany
schaier@tolerogenixX.com
Tel. +49 162 2638005

akampion
Ines-Regina Buth
Managing Partner
info@akampion.com
Tel. +49 30 23 63 27 68


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