The innovative approach of the TolerogenixX procedure is the rapid and simple implementation of individualized immunosuppression in clinical routine while avoiding the side effects of general immunosuppression. The application of the principle of individualized immunosuppression is initially planned for rejection prophylaxis after kidney transplantation and later for the treatment of various autoimmune diseases (e.g. SLE). For transplantation, donor blood cells are treated with mitomycin C (MICs) and then administered to the recipient.
In autoimmune diseases, patient blood cells are treated with mitomycin C and a specific autoantigen and then returned to the patient (Terness et al. PNAS 2008). In both cases, the unique selling point is the modification of immunocompetent cells away from an activating reaction of the antigen towards a suppressive effect. The patent specification "Immunosuppressive blood cells and methods of producing same" protects this process. A phase I study is currently underway at Heidelberg University Hospital for the indication of living kidney transplantation.
In the next step, therapy kits with all the necessary components will be produced, clinically tested and approved for marketing for broad commercialization.
The therapy kits can be adapted with little effort both for the transplantation of other organs and for the treatment of autoimmune diseases.
The state of the art in transplantation is the stressful quadruple immunosuppression, which leads to rejection in more than half of all cases and is often associated with considerable side effects, especially infections, malignancies, etc. Previous attempts at individualized immunosuppression or tolerance generation have either had many side effects, been time-consuming or ineffective.
The TolerogenixX procedure achieves a targeted individualized modification of the body's own immune system, making artificial drug suppression of the immune system no longer necessary in the future. The TolerogenixX procedure can be used as a protective vaccine and for the treatment of autoimmune diseases.
The target group is patients with organ transplants and autoimmune diseases.
Prof. Dr. C. Morath (Nephrology)
PD Dr. M. Schaier (Nephrology)
Prof. Dr. M. Zeier (Nephrology)
Prof. Dr. M. Schmitt (GMP Core Facility)
PD Dr. A. Schmitt (GMP Core Facility)
Dr. C. Kleist (Transplantation Immunology)
Prof. Dr. P. Terness (Transplantation Immunology)
Prof. Dr. G. Opelz (Transplantation Immunology)
Kidney transplant patients face two main problems.
Firstly, they have to take lifelong immunosuppression to prevent rejection of the transplant. This immunosuppression comes with side effects. For example, we are seeing more cases of cancer; in addition, immunosuppressed patients are increasingly at risk of infectious diseases, which can even be fatal.
Secondly, even the immunosuppression administered today is still not able to reliably stop the long-term loss of transplants. Our patients lose about 4% of transplants per year.
We are looking for a solution to this problem by researching an immunosuppression that is only directed against the transplant, but leaves the defense against bacteria, viruses, fungi, cancer cells, etc. unaffected.
We would therefore like to present the results of the TOL-1 study and the preparations for our TOL-2 study, in which the principle of individualized immunotherapy with MIC cells will be tested in comparison to standard therapy.
If you are a patient wishing to participate in this study or a colleague with questions about the treatment concept, please contact Prof. Dr. Christian Morath:
christian.morath@med.uni-heidelberg.de