Beyond Biotech podcast 54 –


1:24 Labiotek news
3:45 TolerogenixX

This week, we discussed with Matthias Schaier, CEO of TolerogenixX, about dealing with organ rejection after transplants.

TolerogenixX GmbH, a biopharmaceutical company developing personalized cellular therapies aimed at achieving sustainable immune tolerance to combat organ rejection and autoimmune disease, has announced that a phase IIb study in kidney transplant patients has received the green light to initiate arm B of the research.

MIC treatment is a personalized cell therapy approach that modulates the immune system through novel modes of action to achieve specific and sustained immune tolerance. This can be applied not only to transplant recipients, but also to patients with autoimmune diseases such as systemic lupus erythematosus and multiple sclerosis.

TolerogenixX has reported positive results from one and three year follow-ups in 10 transplant recipients from the phase I trial of TOL-1 that started at the University Hospital Heidelberg. All patients who had received MIC infusion before kidney transplantation in the TOL-1 clinical trial had a favorable clinical course three years after surgery.

“We are very pleased with this result,” said Christian Morath, CSO TolerogenixX.

“Five years after the transplant, the tolerance is still there. Patients are immunologically more protected, do not show severe accompanying symptoms and are able to significantly reduce immunosuppressive therapy.”

“These are exciting data and very clinically relevant,” added Schaier.

“We see that our MIC therapy opens perspectives on transformative and effective treatment options for kidney transplant recipients. This can reduce the side effects of conventional chemical immunosuppression and provide long-lasting immune suppression without making transplant recipients more susceptible to opportunistic infections. We are now conducting a phase IIb study with a larger series of patients being treated with MIC and a reduced regimen of immunosuppressive drugs. Our preclinical studies also show great potential in autoimmune diseases.”

On the back of these results, TolerogenixX also reported a second closing of €7 million ($7.6 million) of its Series A financing round now totaling €11.6 million ($12.6 million).


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