- TolerogenixX’s MIC-Lx therapy has been granted PRIME designation by the EMA for its potential to reduce or eliminate the need for lifelong immunosuppressive therapy.
- Clinical data spanning up to 10 years of follow-up demonstrate sustained safety and reduced immunosuppression.
Heidelberg, Germany, March 11, 2026 – TolerogenixX, a clinical-stage biopharmaceutical company focused on developing personalized cell therapies to induce lasting immune tolerance in organ transplantation and autoimmune diseases, announced today that the European Medicines Agency (EMA) has granted PRIority MEdicines (PRIME) designation to its leading cell therapy candidate, MIC-Lx. This designation is for its application in individualized immunosuppression for living donor kidney transplantation. The PRIME program is designed to support medicines that address serious diseases with significant unmet medical needs, offering early and enhanced regulatory engagement with the EMA to expedite clinical development and patient access.
Kidney transplantation is the preferred treatment for end-stage renal disease; however, patients require lifelong systemic immunosuppressive therapy to prevent organ rejection. These therapies are associated with considerable side effects, including infections, malignancies, and metabolic complications. TolerogenixX’s MIC-Lx therapy (Modified Immune Cells for Living-donor transplants) is intended to induce donor-specific immune tolerance, potentially enabling transplant recipients to significantly decrease their reliance on chronic immunosuppression.
The PRIME designation follows a favorable assessment by the Committee for Advanced Therapies (CAT) and endorsement by the Committee for Medicinal Products for Human Use (CHMP) during their February 2026 meeting. According to the EMA’s evaluation, existing clinical and non-clinical data support the hypothesis that modified donor immune cells, treated with a cytostatic agent, may induce a tolerogenic immune state in transplant recipients.
Clinical Phase I and ongoing Phase II studies involving renal transplant patients, with follow-up data extending up to 10 years, corroborate the proposed mechanism of action and indicate:
- an absence of donor-specific antibody responses
- a substantial reduction in immunosuppressive therapy
- a decrease in opportunistic infections.
Five-year follow-up data from the Phase I study, published in Frontiers in Immunology in 2023, revealed long-lasting donor-specific immune modulation accompanied by a sustained increase in regulatory B lymphocytes.
“The EMA PRIME designation is a significant acknowledgment of the potential of our MIC technology to transform the current treatment paradigm in transplantation,” stated Prof. Dr. Matthias Schaier, CEO of TolerogenixX. “Our objective is to achieve donor-specific immune tolerance and alleviate the burden of chronic immunosuppression for transplant patients. The clinical data gathered to date suggest that our MIC therapy could offer an effective treatment option for kidney transplant recipients while mitigating the side effects commonly associated with long-term immunosuppression.”
The Company intends to release data from an ongoing Phase IIb trial in the first half of 2027.
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About TolerogenixX
TolerogenixX is a privately held biopharmaceutical company dedicated to developing innovative, personalized therapies designed to induce antigen-specific immune tolerance in transplantation and autoimmune diseases. Its proprietary MIC (modified immune cells) technology aims to precisely modulate the immune system, potentially reducing the necessity for long-term systemic immunosuppression.
The Company’s lead candidate, MIC-Lx, has successfully completed a Phase Ib clinical trial (TOL-1) in kidney transplant recipients, demonstrating sustained safety and tolerability following a single administration while preserving normal immune responses. A Phase IIb study (TOL-2) is currently underway.
Founded in 2016, TolerogenixX is headquartered in Heidelberg, Germany.
About MIC treatment
MIC treatment represents a personalized cell therapy approach that modulates the immune system through a novel mechanism of action to achieve specific and sustained immune tolerance. This approach holds promise not only for transplant recipients but also for patients suffering from autoimmune diseases such as systemic lupus erythematosus and multiple sclerosis.
MIC production is characterized by its speed, safety, and effectiveness. Utilizing cells obtained via leukapheresis, MIC can be manufactured within 24 hours. Thanks to a standardized procedure, MIC production can be readily scaled up and made globally accessible through the proprietary approach developed by TolerogenixX.
Contact
TolerogenixX GmbH
Prof. Dr. med. Matthias Schaier
Im Neuenheimer Feld 162
D-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
