- MIC-Lx therapy receives EMA PRIME designation for its potential to reduce or eliminate life-long immunosuppressive therapy
- Long‑term clinical data with up to 10-year follow‑up support sustained safety and reduced immunosuppression
Heidelberg, Germany, March 11, 2026 – TolerogenixX, a clinical-stage biopharmaceutical company developing personalized cell therapies to induce sustained immune tolerance in organ transplantation and autoimmune diseases, today announced that the European Medicines Agency (EMA) has granted PRIority MEdicines (PRIME) designation to its lead cell therapy candidate MIC-Lx for individualized immuno-suppression in living donor kidney transplantation. The PRIME scheme supports medicines addressing serious diseases with significant unmet medical need and provides early and enhanced regulatory interaction with the EMA to accelerate clinical development and patient access.
Kidney transplantation is the preferred treatment for end-stage renal disease, yet patients require life-long systemic immunosuppressive therapy to prevent organ rejection. These treatments are associated with significant side effects, including infections, malignancies and metabolic complications. TolerogenixX’s MIC-Lx therapy (Modified Immune Cells for Living-donor transplants) aims to induce donor-specific immune tolerance, potentially allowing transplant recipients to significantly reduce chronic immunosuppression.
The PRIME designation follows a positive assessment by the Committee for Advanced Therapies (CAT) and endorsement by the Committee for Medicinal Products for Human Use (CHMP) during its February 2026 meeting. According to the EMA assessment, available 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 in renal transplant patients with follow-up data of up to 10 years support the proposed mechanism of action and indicate:
- absence of donor-specific antibody responses
- substantial reduction of immunosuppressive therapy
- fewer opportunistic infections.
5-year follow-up data from the Phase I study were published in Frontiers in Immunology in 2023 and showed long-lasting donor-specific immune modulation accompanied by a sustained increase in regulatory B lymphocytes.
"The EMA PRIME designation is an important recognition of the potential of our MIC technology to improve the current treatment paradigm in transplantation," said Prof. Dr. Matthias Schaier, CEO of TolerogenixX. "Our goal is to enable donor-specific immune tolerance and reduce the burden of chronic immunosuppression for transplant patients. Clinical data generated so far indicate that our MIC therapy may provide an effective treatment option for kidney transplant recipients while reducing the side effects typically associated with long-term immunosuppression."
The Company plans to publish 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 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.
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
