TolerogenixX develops personalized cell therapies aimed at inducing donor-specific immune tolerance to prevent organ rejection and treat autoimmune diseases. Its lead product, MIC-Lx, is made from donor peripheral blood mononuclear cells modified by the company's proprietary MIC technology and administered intravenously prior to transplantation. MIC production is fast (manufacturable within 24 hours), scalable and uses leukapheresis-harvested donor cells. Five-year Phase I follow-up data show durable donor-specific immunosuppression, increased regulatory B lymphocytes, stable renal graft function, no donor-specific HLA antibodies or acute rejections, and fewer opportunistic infections versus matched controls. The company has expanded its Phase IIb TOL2 study to include an arm B that tests minimal immunosuppression and weaning off certain drugs. Preclinical data also indicate potential application in autoimmune diseases, and the company is pursuing completion of its Phase II program. TolerogenixX is privately held, was founded in 2016 and is based in Heidelberg, Germany; it recently completed a second Series A closing that increased its funding. TolerogenixX GmbH is a Heidelberg-based developer of a patented and clinically tested cell therapy technique for individualized immunosuppression in transplant patients. The company’s process treats patients' white blood cells to induce targeted disabling of undesired immune reactions. In a Phase I clinical trial applied during kidney transplants, treated patients became tolerant of the donated organ. TolerogenixX was founded at Heidelberg University Hospital and is led by CEO Dr. Matthias Schaier. The company plans to pursue further applications in transplantation of other organs and in the causal treatment of autoimmune diseases. It raised seed funding from High‑Tech Gründerfonds and intends to use the proceeds to finance preparations for a Phase II clinical trial beginning in spring 2018.

Total raised

$8M

Funding rounds

2

Latest round

Series A

Latest activity

Jul 2023