PolTREG – innovative therapies for autoimmune diseases
- Global Treg-based cell therapy pioneer – the most advanced in clinical trials
- Creators of PolTREG performed the world’s first TREG administration in human subject
- Patented therapy using Tregs developed by PolTREG in the treatment of type 1 diabetes in children and in multiple sclerosis is – according to the Company’s knowledge – world’s most advanced in clinical development
- No registered drug is currently available that would have a causal action in the therapy of newly diagnosed type 1 diabetes – this is a huge unmet medical need on a global scale
- The Company has its own patented technology to collect and multiply regulatory T lymphocytes under laboratory conditions in accordance with GMP standards, allowing highly effective production of TREG lymphocytes
- One of the world’s most recognizable teams in immunology and diabetes, led by Prof. Piotr Trzonkowski, awarded the Foundation for Polish Science 2017 in the field of life sciences and “for research on regulatory T cells and their pioneering use in cell therapy of human diseases”
- Top-class Scientific Council comprising of experts and authority figures, including: Camillo Ricordi – Professor and Director of the Diabetes Research Institute and the Cell Transplant Center at the University of Miami, Florida He discovered a method for isolation of insulin-producing cells from the pancreas The method is now employed worldwide
PolTREG is an innovative biotechnological company developing therapies using T-regulator cells (TREGS) at an advanced clinical stage, targeting unmet medical needs in the area of autoimmune diseases, including the treatment of type 1 diabetes and multiple sclerosis. The Company is currently conducting various stages of 2 major groups of R&D projects (treatment of type 1 diabetes in children and multiple sclerosis) constituting a platform for effective and innovative therapies for various autoimmune diseases and the development design of the Treg 2.0 platform.
PolTREG is in the course of an investment aimed at creating a modern R&D centre designed for the development and application of TREG in innovative therapies for autoimmune diseases. The company obtained funding from the European Regional Development Fund on the construction of the Centre, amounting to over PLN 10.5 million (own contribution of PLN 13.1 million) and a grant from PARP of PLN 6 million for the creation, equipment and commissioning of a new production laboratory intended for commercial production of TREGS preparations. The construction of the Centre will also be financed from the Company’s own funds and the proceeds from the issue of shares (IPO). The completion date of the Centre is planned for the second half of 2022.
Works on the use of TREGS in the treatment of type 1 diabetes started in 2006 at the Medical University of Gdańsk and were conducted, among others, by founders and significant shareholders of the Company: Prof. dr hab. n. med. Piotr Trzonkowski, prof. dr. hab. n. med. Małgorzata Myśliwiec and prof. dr. hab. n. med. Natalia Marek-Trzonkowska. The research conducted in successive years demonstrated the effectiveness of developed solutions, which led to the creation of PolTREG in 2015 as spin-off from the Medical University of Gdańsk, whose aim is to conduct the stages of clinical trials, development of new therapies, as well as commercialization of solutions.
The Company completed in 2015 phase 1 of clinical trials in type 1 diabetes in children and phase 1/2 was completed in 2020. Currently following the procedure Scientific Advice with the European Medicines Agency (EMA) phase 2/3 of the study in the treatment of patients with newly diagnosed type 1 diabetes is under development. The second study in type 1 diabetes will be a study 1/2, which involves identifying and treating patients in the pre-symptomatic period. As part of this study, the Company intends to conduct a study among patients who, due to genetic factors, are at high risk of developing type 1 diabetes. This study may open a completely new chapter in approach to the disease because at present, due to the lack of available treatment, screening and treatment at an early stage of the disease is not being conducted. Dissemination of screening, allowing diagnosis of the disease and treatment initiation will be important for the use of pre-symptomatic type 1 diabetes therapy.
The Company has also completed with very promising phase 1 results of the clinical trial in relapsing-remitting multiple sclerosis.
CRO (contract research organization) Parexel is a advisor of the Company during the clinical trial process.
Since 2019, the Company, in collaboration with the University Clinical Centre of the Medical University of Gdańsk, based on the so-called hospital exemption, has initiated commercial TREG therapy for patients with type 1 diabetes. So far, a dozen or so such therapies have been performed.
Currently, the Company team consists of 20 persons, and after the start of a new laboratory and the completion of preparation for subsequent phases of clinical trials, the team will comprise of approx. 40 people.
PolTREG has a very comfortable cash situation for financing further development.
It has a total of nearly PLN 150 million available in the form of cash on the balance sheet, the funds from IPO, as well as existing and not yet used grants.
PolTREG conducted a public offer of shares in 2021, where new shares were issued for PLN 100 million (gross). Emission funds will be dedicated to funding key strategic objectives of the company, including clinical research of cell therapy in the treatment of type 1 diabetes and multiple sclerosis and the development of the Treg 2.0 platform (antigen specific Tregs and CAR-TREGs, which will develop together with AZTherapies, one of the global leaders in this area), as well as to finance the construction of its own research and development centre and a new production laboratory intended for commercial production of TREGS formulations in Gdańsk.