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TolerogenixX secures seed funding and completes Phase I clinical trial

TolerogenixX GmbH has developed a patented and clinically tested cell therapy technique for individualised immunosuppression in transplant patients. The technique enables the targeted disabling of undesired reactions caused by the immune system’s defences. As a seed stage investor, High-Tech Gründerfonds (HTGF) will finance this innovative technique and the preparations for Phase II of the clinical trial, which begins in spring 2018. Further applications of the technique include the transplantation of other organs and causal treatment of autoimmune diseases.

For transplants as well as autoimmune diseases, the body’s immune system detects tissue found in the body as foreign and its defences try to fight it. To date, this response in patients has been treated using a combination of various medications. However, the medications weaken the overall immune system and harbour enormous risks, such as serious infections and an increased risk of heart attacks and cancerous diseases.

The new cell therapy technique from TolerogenixX will in future help to counteract these risks. The TolerogenixX method works by suppressing the immune system in a targeted manner, effectively serving as an individualised form of immunosuppression. To perform the technique, white blood cells are extracted from the organ donor one week ahead of the scheduled transplant. The white blood cells are then altered using the TolerogenixX treatment kit and transfused to the organ recipient. This ensures that the recipient’s body gets used to the characteristics of the donor. An organ transplanted from the same donor is then no longer detected as foreign but is instead tolerated by the recipient. This technique also offers huge opportunities with respect to preventative treatment and the treatment of autoimmune diseases such as multiple sclerosis and systemic lupus erythematosus.

Phase I of the clinical trial was recently completed successfully in kidney transplants. The trial not only showed the excellent compatibility of the TolerogenixX technique but also its impressive efficacy. Immunological tests conducted one day before the scheduled transplant provided an impressive demonstration of how the organ recipient developed tolerance towards the donor’s features. At the time of the tests, the recipient had not taken any immunosuppressive drugs.

“The results of the Phase I clinical trial show that by using the TolerogenixX technique, the rejection of organs after transplants can be effectively prevented,” says Dr. Matthias Schaier, CEO of TolerogenixX. “This is a real quantum leap in the treatment of transplant patients. In future, it will no longer be necessary to take various medications with numerous side effects.”

Dr. Philipp Rittershaus, Investment Manager at HTGF, is convinced of the technique’s potential: “The TolerogenixX technique represents a milestone in the field of individualised immunosuppression. The seed stage financing will now enable the company to continue its clinical research and prepare for the multicentric Phase II clinical trial, which is scheduled for spring 2018.”


  • The transforming growth factor (TGF) belongs to the so-called cytokines, which serve as signal molecules in cell communication. TGFs play an important role in growth and differentiation of many cells and tissues.
  • Autoimmune diseases are diseases that are characterized by an immune system attacking the own body cells. This is caused by a failure of the immune system to discriminate between self and foreign cells or tissues.
  • Biomolecules which can bind active agents are called targets. They can be receptors, enzymes or ion channels. If agent and target interact with each other the term agent-target-specific effect is used. The identification of targets is very important in biomedical and pharmaceutical research because a specific interaction can help to understand basic biomolecular processes. This is essential to identify new points of application.
  • Engrafting cells, tissue or organs from a donor into a recipient is called transplantation. There exist several types of transplantation which are classified in three categories: function, location and derivation. Engrafting an organ of a different species into a recipient is called xenogenic transplantation, whereas an allogenic transplantation describes the tranfer of grafts from a donor into a recipient being a member of the same species. If donor and recipient are the same individual, the transplantion is called autogenic. Furthermore there exists a syngenic transplantation which is characterized by grafts originating from the uniovular twin. Furthermore, engrafting artificial material is called alloplastic transplantation. To suppress the natural immune response being raised by the transplanted organs, recipients have to be administered immunosuppressants. Since 1997 in Germany the legitimacy of organ donation is regulated by the Transplantation Law. In the case of brain death, an organ donor card has to be available or relatives have to agree with the organ donation. Today, the most frequently transplanted organs are heart, liver, kidney and cornea.

About TolerogenixX GmbH:

TolerogenixX, a start-up founded at Heidelberg University Hospital, helps to develop an individualised immune system in patients through the patented treatment of white blood cells. Pre-seed financing was provided through the EXIST Transfer of Research funding programme organised by the German Federal Ministry for Economic Affairs and Energy. The start-up has received seed stage funding from High-Tech Gründerfonds.


About High-Tech Gründerfonds:

High-Tech Gründerfonds (HTGF) is Germany’s most active seed stage investor. With EUR 576 million under management in two funds we provide financing for technology-driven companies active in a wide range of fields, including robotics, IoT and energy, Medtech and Biotech, chemicals and software. Investors in this public-private partnership include the German Federal Ministry of Economics and Energy, the KfW Banking Group, and 18 strategic corporate investors.


Website address: https://www.gesundheitsindustrie-bw.de/en/article/press-release/tolerogenixx-secures-seed-funding-and-completes-phase-i-clinical-trial/