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.
This arm consisted of patients who received minimally immune suppressive drugs, reduced tacrolimus and completely weaned mycophenolate sodium and enteric-coated methylprednisolone. The study involved 63 transplant couples, each consisting of donors and transplant recipients. The protocol has been published in BMJ Open.
The company also published five years of follow-up data from its phase I trial of MIC-Lx cell therapy. The results are published in Frontiers in Immunologydemonstrated that use of TolerogenixX MIC cell therapy prior to transplantation provided durable donor-specific immunosuppression and a sustained and significant increase in regulatory B lymphocytes.
About MIC treatment
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.
MIC production is fast, safe and effective. MIC can be produced within 24 hours, using cells obtained by leukapheresis. Due to standard procedures, MIC production can be scaled up and available globally using the approach developed by TolerogenixX.
MIC-Lx TolerogenixX cell therapy is a curative cell treatment for inducing donor-specific immune tolerance in transplant recipients and also potentially for autoimmune patients. In living donor transplants such as kidney transplants, peripheral blood mononuclear cells (PBMCs) from the donor are harvested by leukapheresis. The donor PBMC is then modified by the company’s MIC technology. The resulting cell therapy product, MIC-Lx, is then given intravenously to the transplant recipient prior to transplant.
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.
In a current publication, the company reports that these 10 MIC patients continued to have excellent clinical outcomes at five years, with stable kidney transplant function, no donor-specific human leukocyte antigen (DSA) antibodies or acute rejection, and no opportunistic infections. that’s bad. In comparison, a retrospectively matched control group that received standard immunosuppressive therapy had a higher incidence of donor-specific HLA antibodies and more opportunistic infections.
MIC patients continued to display a lack of in vitro anti-donor T lymphocyte reactivity and high titers of potent regulatory B-cells essential for a functional immune system five years after surgery. The company says this applies to four patients who had been infused with the highest cell counts seven days before surgery, and who received low-immunosuppressive drugs during follow-up.
Long-lasting immune suppression
“We are very pleased with these results,” 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.”
“This is exciting data and very clinically relevant,” added Matthias Schaier, CEO of TolerogenixX.
“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 closing its second €7 million ($7.6 million) of its current Series A financing round for a total of €11.6 million ($12.6 million).
“We are very pleased to be able to add €7 million to our Series A financing round,” said Schaier.
“In the current financing environment, this is a further validation of our approach, allowing us to successfully complete the phase II program.”