PolTREG CEO Trzonkowski co-authors peer-reviewed article showing scientific progress in T-reg autoimmune therapy

Gdańsk, Poland – 30 January 2024 – PolTREG S.A. (Warsaw Stock Exchange: PTG) , a clinical-stage biotechnology company developing cell therapies for a wide range of autoimmune diseases, announced that Prof. Piotr Trzonkowski, CEO, has co-authored a peer-reviewed article in Frontiers in Immunology, the world’s fifth most-cited immunology journal, laying out the decades of scientific progress underlying the company’s portfolio of ground-breaking clinical-stage therapies for diseases such as Type-1 Diabetes (T1D) and Multiple Sclerosis (MS).

Prof. Trzonkowski, together with other researchers from the Medical University of Gdańsk, joined contributing authors from the teams of Prof. Ye Htun Oo at University of Birmingham, Prof. Anke Fuchs from the Technical University of Dresden, and Prof. Natalia Marek-Trzonkowska from the International Centre for Cancer Vaccine Science at the University of Gdańsk. The review highlights key advances enabling the development of a new class of T-regulatory cell (Treg) therapies with disease-modifying potential, including:

• The identification of markers and functional properties of diverse populations of Tregs that allow their identification, quantification and assessment in health and disease,
• The significance of specific markers in the therapeutic use of Treg cells,
• Discoveries that are enabling genetic manipulation of Tregs to enhance their therapeutic potential, and
• Recent breakthroughs that hold the key to effectively harnessing human Treg cells to treat autoimmune diseases.

“It is encouraging to see the growing awareness among scientists and medical doctors of the potential that cells, harvested from a patient’s own body, have to improve the way we treat a wide range of autoimmune diseases,” said Prof. Trzonkowski. “PolTREG is developing all of the most promising Treg therapies, from autologous monoclonal therapies to preclinical next-generation engineered cells, including CAR-Tregs, antigen-specific Tregs and TCR-Tregs.”

PolTREG boasts the most advanced pipeline for Treg cell therapies in autoimmune disease, with its lead candidate, PTG-007, in mid-stage clinical studies for two indications in T1D and two in MS. For CAR-Tregs, the company expects to start a First-in-Human clinical trial for two neurodegenerative diseases - MS and Amyotrophic Lateral Sclerosis (ALS) – in early 2025.

PolTREG was the first company in the world to administer T-reg therapies to patients and the first to start receiving revenues from its lead product. So far, PolTREG has successfully treated 27 patients with PTG-007 commercially under a hospital exemption program in Poland, where the company is completing its own state-of-the-art manufacturing facilities.

T-regulatory cells (Treg) are crucial regulators of the immune system, seeing to it that other leukocytes do not attack the body’s own cells. Treg therapeutics have advantages over traditional drugs in that they only act at the site of the inflammation, and switch off when the inflammation is over. When found in the body, Treg cells are polyclonal, meaning they can react to a number of different antigenic triggers. They can be genetically modified to become monoclonal, reacting, for instance, to specific diseases.

PolTREG has developed patented processes, collecting Tregs from a patient’s own body, multiplying them ex vivo, and then injecting them back in the patient’s own bloodstream for therapeutic effect, so-called autologous treatment. A Phase 2 clinical study of PTG-007 in T1D showed half of patients in clinical remission 24 months into the study, demonstrating the strong potential these therapies have to become powerful disease-modifying treatments.

PolTREG (Gdańsk, Poland; WSA:PTG) is a global leader in developing autoimmune therapies based on T-regulatory cells (Tregs). Its lead product, PTG-007, autologous Treg treatment for early-onset Type-1 Diabetes (T1D) is ready for Phase 2/3 clinical testing, for which the company is seeking a partnership. The company will launch Phase 2 trials for PTG-007 to treat Multiple Sclerosis (MS), in the second half of 2024 for RRMS and PPMS. PolTREG also has engineered Tregs, including CAR-Tregs, antigen-specific Tregs and TCR-Tregs, in the preclinical stage. PolTREG has completed four clinical trials with more than 100 patients treated with Tregs.

For more information please visit www.poltreg.com.

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• 20240130 PolTREG PR FII peer-reviewed article final clean