1:24 Labiotech news
3:45 TolerogenixX
This week, we have a conversation with Matthias Schaier, CEO of TolerogenixX, about tackling rejection of organs following transplantation.
TolerogenixX GmbH, a biopharmaceutical company developing personalized cellular therapies aimed at achieving sustained immune tolerance to combat organ rejection and autoimmune diseases, has announced that its phase IIb study in renal transplant patients has received the green light to initiate the B arm of the study.
MIC treatment is a personalized cell therapy approach modulating the immune system via a novel mode of action to achieve a specific and sustained immune tolerance. It can not only be applied to transplant recipients, but also to patients with autoimmune diseases such as systemic lupus erythematosus and multiple sclerosis.
TolerogenixX has already reported positive results from the one- and three-year follow-up of 10 transplant recipients of its TOL-1 phase I trial initiated at Heidelberg University Hospital. All patients who had received MIC infusions prior to kidney transplantation in the TOL-1 clinical trial had a favorable clinical course three years after surgery.
“We are very pleased about these results,” said Christian Morath, CSO of TolerogenixX.
“Five years after transplantation, tolerance is still present. Patients are immunologically better protected, show no severe concomitant symptoms and were able to significantly reduce immunosuppressive therapy.”
“These are exciting and clinically highly relevant data,” Schaier added.
“We see that our MIC therapy opens the perspective of a transformative and effective treatment option for kidney transplant recipients. It can reduce the side effects of conventional chemical immunosuppression and provide for lasting immune suppression without making the transplant recipients more susceptible to opportunistic infections. We are now conducting a phase IIb study with a larger series of patients treated with MIC and a reduced immunosuppressive drug regimen. Our preclinical studies also demonstrate great potential in autoimmune disease.”
On the back of these results, TolerogenixX also reported a €7 million ($7.6 million) second closing of its Series A financing round now totaling €11.6 million ($12.6 million).