TolerogenixX revolutionises kidney transplantation
TolerogenixX expands Phase II immune-tolerance trial and closes EUR 12 million Series A financing
TolerogenixX GmbH, a biopharmaceutical company developing personalized cellular therapies aimed at achieving sustained immune tolerance to combat organ rejection and autoimmune diseases, announced that in the TOL2- Phase IIb study in renal transplant patients TolerogenixX has received green light by the Safety Board to initiate the B arm of the study. This arm consists of patients receiving minimal immune suppression drugs, reducing tacrolimus and weaning off enteric-coated mycophenolate sodium and methylprednisolone completely. The study enrolls 63 transplant couples consisting of a donor and a transplant recipient, respectively. The protocol has been published in BMJ Open.
Furthermore, the company is publishing 5-year follow-up data of a Phase I trial of its MIC-Lx cell therapy. The results published in Frontiers in Immunology demonstrate that the use of TolerogenixX's MIC cell therapy prior to transplantation provides long-lasting donor-specific immunosuppression and a sustained, significant increase in regulatory B lymphocytes.
TolerogenixX's MIC-Lx cell therapy (Modified Immune Cells for Living-donor transplants) is a curative cell treatment to induce donor-specific immune tolerance in transplant recipients and also bears potential for autoimmune patients. In living donor transplantation such as kidney transplantation, peripheral blood mononuclear cells (PBMCs) of the donor are harvested by leukapheresis. Donor PBMCs are then modified by the Company's proprietary MIC technology. The resulting cell therapy product, MIC-Lx, subsequently is administered intravenously to the transplant recipient prior to transplantation.
TolerogenixX has already reported positive results from the 1 and 3 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 3 years after surgery. In the current publication, the Company reports that these 10 MIC patients continued to have excellent clinical outcomes at 5 years, with stable renal graft function, no donor-specific human leukocyte antigen (DSA) antibodies or acute rejections, and no severe opportunistic infections. In comparison, a retrospectively matched control group receiving standard immunosuppressive therapy had a higher incidence of donor-specific HLA antibodies (log rank P = 0.046) and more opportunistic infections (log rank P = 0.033).
Importantly, MIC patients continued to show a lack of anti-donor T lymphocyte reactivity in vitro and a high titer of potent regulatory B-cells crucial for a functional immune system until year 5 after surgery. Specifically, this holds true for the four patients who had been infused the highest cell number 7 days before surgery and who received low immunosuppressive medication during follow-up.
"We are very pleased about these results," said Prof. Dr. 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," added Prof. Dr. Matthias Schaier, CEO of TolerogenixX. "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 promising results, TolerogenixX also reported a EUR 7 million second closing of its Series A financing round now totaling EUR 11.6 million.
"We are very pleased that we were able to add EUR 7 million to our Series A financing round," Schaier said. "In the current financing environment, this is a further validation of our approach, enabling us to successfully complete our Phase II program."
New investor in the round is DB Speciality GmbH & Co. KG, Neu Ulm, an investment company of the health care specialist Dr. Dietrich Bruchmann. Dr. Bruchmann is a very experienced investor with highest expertise in the life science sector. Existing investors include Kalodion Fond I, CventureS, Nisus, HTGF, Dr. Dr. Dorow, Dr. Dr. Fakler and Biotech Mountains BV.
Original publication
Five-year follow-up of a phase I trial of donor-derived modified immune cell infusion in kidney transplantation; Front. Immunol., 11 July 2023, Sec. Immunological Tolerance and Regulation
Morath C, Schmitt A, Schmitt M, et al.; Individualised immunosuppression with intravenously administered donor-derived modified immune cells compared with standard of care in living donor kidney transplantation (TOL-2 Study): protocol for a multicentre, open-label, phase II, randomised controlled trial; BMJ Open 2022;12:e066128.
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