November 14th is World Diabetes Day. Diabetes affects over half a billion people worldwide. On the birthday of Charles Best, co-inventor of insulin therapy, we commemorate the breakthrough that has saved millions of lives. Today, over a century later, another breakthrough in diabetes treatment may come from Poland.
Diabetes is a chronic disease that leads to many serious complications. It damages blood vessels and nerves, and is a leading cause of blindness, kidney failure, heart attacks, strokes, and lower limb amputations. It ranks seventh among the leading causes of death worldwide.
While type 2 diabetes is the most common, closely linked to lifestyle, and affects over 500 million people, type 1 diabetes has a completely different cause. It is an autoimmune disease, independent of diet or physical activity, which, in its symptomatic phase, affects approximately 9.5 million people worldwide, including as many as 1.8 million children. It is usually diagnosed in childhood.
For the past century, insulin therapy was the only solution for patients. Insulin controlled blood sugar levels but did not address the cause of the disease. In recent years, scientists have increasingly focused on slowing the destruction of pancreatic cells and preventing the progression of the disease, rather than treating the symptoms. The first drug of this kind, the antibody teplizumab, was approved in the US in November 2022 for extending the pre-symptomatic period. Unfortunately, patients eventually develop diabetes after several years.
“Although teplizumab is currently only registered in the US, the entire approach to type 1 diabetes is changing globally. Previously, it was diagnosed only after symptoms appeared. Today, thanks to tests detecting the presence of autoantibodies, we can detect the autoimmune process long before the disease appears,” says Prof. Piotr Trzonkowski, CEO and co-founder of PolTREG SA
PolTREG’s goal is to develop a therapy that will completely halt the progression of the disease. The company is focusing on children who have not yet developed the disease but who have antibodies indicating the onset of the inflammatory process. A clinical trial is underway involving 150 children aged three and older who, due to genetic predisposition, are at high risk of developing type 1 diabetes.
“Currently, children with autoantibodies must wait many years before they progress to the second phase of the disease (stage 2), in which they can be treated with Teplizumab. This phase is much shorter than Phase 1, and the patient develops symptoms of the disease relatively quickly and progresses to the final stage (stage 3). Although the segment of patients eligible for Teplizumab treatment is estimated at “only” 1.7 million globally, an international pharmaceutical company paid almost USD 3 billion for the rights to this drug. Considering the high chances of our therapy demonstrating greater efficacy than Teplizumab and the more than 12-fold larger group of patients in the first phase of the disease, we are very optimistic about the commercial potential of our therapy,” says Mariusz Jabłoński, member of the management board of PolTREG SA.
PolTREG has over 17 years of experience in TREG cell therapy, natural regulators of the immune system. The therapy involves drawing blood from the patient, multiplying their own TREG cells, and then injecting them back into the body. By using the patient’s own cells, the therapy is safe, well-tolerated, and effective, as confirmed by over 12 years of follow-up of those who received it.
“TREG therapy is ideal for young children. It’s a treatment based on the patient’s own cells, without the risk of rejection and side effects typical of traditional immunosuppressive therapies,” emphasizes Prof. Piotr Trzonkowski.
PolTREG is one of the few biotechnology companies in the world conducting research on a therapy that not only slows down but may also prevent the onset of type 1 diabetes symptoms. Clinical data collected on a group of over 100 patients who have already received the therapy confirms the safety and effectiveness of the therapy, which has sparked the interest of experts around the world, including the US FDA regulator.
“The European Medicines Agency’s (EMA) approval to conduct this study and the FDA’s positive position regarding the prospect of initiating the study in the US were possible solely because of long-term observations of patients treated with our product. Therefore, competitors will likely need to present similar safety evidence before receiving approval to begin the study in young children, even 3 years old, in whom the disease process has already begun but clinical symptoms will not appear until many years later,” emphasizes Mariusz Jabłoński.
The year 2025 could be a breakthrough for the company. PolTREG has completed a study confirming the long-term effectiveness of the therapy and established a US subsidiary, Immuthera, which is working to commercialize the drug in the US market. The scientific advisory board includes eminent specialists, including Prof. Jay Skyler, Prof. Desmond Schatz, and Prof. Lawrence Steinman, all recognized authorities in the field of pediatric diabetes.
“At PolTREG, we focus on TREG cells, which have the potential to treat many autoimmune, neurological, and cancer diseases. However, it is in the treatment of type 1 diabetes that we have the most experience,” adds Prof. Piotr Trzonkowski.
World Diabetes Day was established in 1991 by the International Diabetes Federation and the World Health Organization in response to growing concerns about the growing health risks posed by diabetes. World Diabetes Day is observed annually on November 14, the birthday of Frederick Banting, who, with Charles Best, discovered insulin in 1922.
PolTREG SAPolTREG is a biotechnology company focused on developing innovative therapies using T-regulatory T-cells (TREGS), as well as developing combination therapies combining TREGs with antibodies. The company is a global leader in cell therapies based on polyclonal TREG cells. The company’s scientists and co-founders conducted the world’s first human administration of a TREG preparation. Therapeutic areas in which PolTREG therapies are being developed include various autoimmune diseases such as type 1 diabetes, multiple sclerosis, and amyotrophic lateral sclerosis.
More information on the website:
Immutheris a pioneer in the field of innovative cell therapies being clinically developed in the United States and Canada. The company will conduct clinical trials of projects originally developed by PolTREG under FDA regulations in the US, as well as projects licensed from US institutions. Immuthera will have full access to PolTREG’s research and development facilities and its portfolio of projects. The company is currently seeking investors to begin manufacturing and clinical development of these therapies in the US.
More information at: https://immuthera.bio/
Contact: ir@poltreg.com
For additional information please contact:
Media contact:
Michał Wierzchowski, cc group
Tel.: +48 531 613 067
michal.wierzchowski@ccgroup.pl
Contact for investors:
Agata Dzięciołowska, cc group
Tel.:+48 606 205 119
