TolerogenixX

About TolerogenixX

TolerogenixX GmbH is a German biopharmaceutical company operating in the HealthTech and Life Sciences sectors, specifically focusing on drug discovery and biotechnology. Founded in 2016 as a spin-off from Heidelberg University Hospital, the company is spearheaded by CEO Dr. Matthias Schaier, CSO Prof. Dr. Christian Morath, and CTO PD Dr. Anita Schmitt. Dr. Schaier has a background as a consultant at the University of Heidelberg and holds an MBA, while Dr. Morath has experience as a Deputy Medical Director and holds a Dr. med. from Heidelberg University and a Master's in Health and Business Administration. The company's work originated from research conducted at the University of Heidelberg.

The core of TolerogenixX's business is a patented, personalized cell therapy technique called Modified Immune Cell (MIC) treatment, designed to induce sustained, specific immune tolerance. This therapy targets two primary client groups: organ transplant recipients and patients with autoimmune diseases like systemic lupus erythematosus (SLE) and multiple sclerosis. For transplant patients, the therapy, known as MIC-Lx, aims to make them tolerant of a donated organ, thereby preventing rejection. In the case of autoimmune diseases, the patient's own blood cells are treated and re-infused to suppress the unwanted immune response against their own body. The key benefit is the potential to significantly reduce or even eliminate the need for lifelong conventional immunosuppressive drugs, which often come with severe side effects such as increased risk of infection and cancer.

The MIC-Lx production process is a key feature. It involves harvesting peripheral blood mononuclear cells (PBMCs) from the organ donor via leukapheresis. These cells are then treated with the company's proprietary technology, which involves transient exposure to mitomycin C, an agent that prevents the cells from expanding after infusion but induces a state that promotes immune tolerance in the recipient. This process is notably fast, with the cell therapy product ready for intravenous administration within 12-24 hours, and does not require genetic engineering. The business model involves manufacturing the MIC cells at centralized hubs, with the first operational in Heidelberg, and distributing them to hospitals globally. TolerogenixX has shown promising results in clinical trials, with a completed Phase Ib trial and an ongoing Phase IIb trial (TOL-2) for kidney transplant patients demonstrating long-term safety and efficacy. The company is venture capital-backed, having secured a Series A round totaling €11.6 million ($12.6 million) by July 2023 from investors including High-Tech Gründerfonds (HTGF) and DB Speciality Invest.