During 80th Scientific Sessions of the American Diabetes Association (12-16.06.2020) the scientists from STRATEGMED TREGS consortium and PolTREG company presented for the first time presumptive results of the phase II trial with T regulatory cells. From the tested approaches, the combined treatment with T regulatory cells and antiCD20 antibody proved to be the most promising. The patients treated with this combined scheme were in the clinical remission almost throughout entire 2-year-lasting follow-up, being administered with less than 0.5 units of insulin per kg body weight daily. At the same time, they were characterized by the best metabolic control with glycosylated haemoglobin HbA1c below 6.5%. The patients treated with this combined regimen achieved the longest insulin-independence which lasted as long as 18 months post-treatment.
Why does insulin trigger diabetes and what is the role of T regulatory cells?
Poltreg S.A. took a part in the resrearch just published in BMJ Open Diabetes Research and & Care. The work is a collaborative study of the medical universities from Gdańsk, Łódź, Katowice, University of Gdańsk, Regional Blood Bank and Poltreg S.A. in which the scientists proved that insulin is not only the hormone but also a dominant autoantigen involved in the development of type 1 diabetes
The links between insulin and the development of type 1 diabetes are known but the current work explains how insulin antigens trigger the progression of disease. Namely, the fragments of proinsulin sensitize and activate the immune system, which starts pathologic response against pancreatic islets secreting the hormone.
Why does not everybody develop the diabetes? It is because antigen-specific T regulatory cells, which are able to stop the activation of the immune system in the majority of people. The number of these cells is extremely low (below 0,01% in the peripheral blood) and only the recent laboratory tools used in the presented work were able to detect them.
The results of the work allowed the scientists from Poltreg S.A. and Medical University of Gdańsk to create the next generation of cellular drug which will be able to stop the activity of the immune system against insulin fragments and pancreatic islets.
Full text of the paper is available at: http://drc.bmj.com/cgi/content/full/8/1/e000873
The work was supported by the grants LIDER/160/L-6/14/NCBR/2015, STRATEGMED1/233368/1/NCBR/2014 and POIR.01.01.01-00-0769/15-03 from National Centre for Research and Development.
Final report from the study on safety of Tregs in multiple sclerosis
Medical University of Gdańsk together with Poltreg’s scientists submitted final report from the study: „Cell therapy of multiple sclerosis with ex vivo expanded CD4+CD25+CD127- T regulatory cells” to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. The results wil be published soon in the specialist journal.
Poltreg S.A. attended the meeting ‘Business in the Genes’ at the Warsaw Stock Exchange. We presented the progress of the company and reported accomplishment of phase II study in type 1 diabetes and phase I in multiple sclerosis. We also showed our current preparatory work on pivotal phase III study in type 1 diabetes in Eurpe and USA. We have also informed about hospital exemption procedure, which allows us to offer the therapy in the University Hospital in Gdańsk. The first patients were administered with the preparation already. Finally, we discussed current financial needs of the company and the progress of the fundraising to date.
Prof. Trzonkowski presented the lecture ‘Treatment of autoimmune diseases with T regulatory cells in humans – promises and hurdles’ during the workshop ‘Discovery to clinical applications of regulatory T cells in autoimmunity and transplantation’ organized by the British Society of Immunology.
The patient’s trust award ‘Złoty Otis’ for her achievements in endocrinology and diabetology to Prof. Myśliwiec
Prof. Myśliwiec elected again to be the member of the Board of the Polish Society of Diabetology for the term 2019-2023.
The Award of the Polish Society of Diabetology to Prof. Myśliwiec for Her spectacular achievements in the clinical and experimental science in diabetology. The ceremony took place during the the XX Congress of the Polish Society of Diabetology in Lublin, in which prof. Myśliwiec gave the inaugural Jakub Węgierka’s lecture: ‘Running for success in diabetology’.
Scientists from Poltreg presented their academic and commercial experience with the Tregs at the TREG SUMMIT in Boston.
Poltreg presented its current strategy at LSX World Congress in London. The Congress is a high-calibre, senior executive, conference, exhibition and partnering event providing the education, strategies, solutions and contacts that life science executives need to enable more effective investment, planning and strategic growth within their businesses.
Prof. Piotr Trzonkowski gave a lecture on TREG method during European Congress of Immunology in Amsterdam. The congress is the biggest and the most important European event on immunology taking place every three years in different European cities.
PolTREG has been awarded 2 500 000 Euro grant in Horizon2020 in the healthcare biotechnology sector.(project 830559 – TREG: TREG – innovative cell therapy targeting Diabetes Type 1). We are the only Polish SME company that received support in this instrument in the area of healthcare. The money will be spent on the preparations to phase III clinical trial in type 1 diabetes.
Report on adverse effects from clinical trials on type 1 diabetes and multiple sclerosis confirmed good safety profile of the treatment.
Scientists from Poltreg are co-authors of the minimum information model on Treg cell therapy (MiTREG). The paper describing MiTREG brought together over 50 scientists from all over the world.
Last patient recruited into phase I trial on multiple sclerosis in STRATEGMED TREGS programme. Full results of the study will be available in second quarter of 2019.
Inventor of TREG method Prof. Piotr Trzonkowski has received the Foundation for Polish Science Prize 2017 in the life and earth sciences for studies on regulatory T cells and their pioneering use in cell therapy of human diseases. This is the most important scientific prize in Poland.
Last patient recruited into phase II trial on type 1 diabetes in STRATEGMED TREGS programme. Full results of the study will be available in third quarter of 2019.
Scientists from Poltreg took a part in the final meeting of the “Action to Focus and Accelerate Cell-based Tolerance-inducing Therapies (AFACTT). This is Europe’s Biggest Research Network on cell-based tolerance-inducing therapies that brings together around 100 scientists from 20 European universities.
Scientists from Poltreg published report with new data on laboratory technique increasing stability and quality of TREG preparation used in the treatment. The method is a subject of new patent application.
Scientists from Poltreg published report describing long-term effects of the therapy. The report proves that the patients treated with TREG cells could produce insulin more than 2 years after administration of the preparation.