PolTREG is an innovative biotechnology company that develops therapies using T-regulatory cells (TREGS), targeting previously unmet medical needs in the field of autoimmunity – including treatment of type 1 diabetes in children and multiple sclerosis. Research on these medical solutions is at an advanced clinical stage. The company is creating a platform to develop effective and innovative therapies for various autoimmune diseases and a project to develop the Treg 2.0 platform. The company was established as a spin-off of the Medical University of Gdansk to develop and commercialize the patented TREG method.
The development of TREGS for the treatment of type 1 diabetes began in 2006 at the Medical University of Gdansk and was led by, among others, the founders and significant shareholders of the company: Professor of Medical Science Piotr Trzonkowski, Professor of Medical Science Małgorzata Myśliwiec and Professor of Medical Science Natalia Marek-Trzonkowska. Research conducted in subsequent years demonstrated the effectiveness of the solutions, which led to the establishment of PolTREG in 2015 as a spin-off from the Medical University of Gdansk. Its goal is to conduct clinical trials, develop new therapies, and commercialize solutions.
The company completed a Phase I clinical trial in type 1 diabetes in children in 2015 and a Phase I/II study was completed in 2020. Currently, after a Scientific Advice procedure with the European Medicines Agency (EMA), a Phase II/III study for the treatment of patients with newly diagnosed type 1 diabetes is in preparation. The second study in type 1 diabetes will be an I/II study to identify and treat patients in the presymptomatic period. As part of this study, the company intends to screen patients who are at high risk of developing type 1 diabetes due to their genetics. This study may open a completely new chapter in the approach to this disease, as screening and treatment at an early stage of disease development is currently not conducted due to lack of available treatment. The proliferation of screening tests that allow rapid diagnosis of the disease and initiation of treatment will be important for the application of type 1 diabetes therapy in the presymptomatic phase. The company has also completed, with very promising results, a Phase I clinical trial in the relapsing-remitting form of multiple sclerosis.
Starting in 2019, in cooperation with the University Clinical Center of the Medical University of Gdansk, based on the hospital exception procedure, the company started to commercially offer TREG therapy for patients with type 1 diabetes. So far, more than a dozen such therapies have been conducted.
The company has financed the implementation of research and development projects from grants and private investors. To date, it has secured approximately PLN 28.8 million in grants, including PLN 12.2 million for the development of the TREG method, and the remainder for the creation of the R&D center and a new laboratory.
In addition, the company has made its debut on the Warsaw Stock Exchange – the nearly PLN 100 million raised will be allocated to further research and to the construction of its own research and development center and the creation of a new production center for the commercial production of TREG preparations.