Teplizumab

This article presents the longest published follow-up of patients with type 1 diabetes treated with TREGs. Long-term effectiveness and safety have been confirmed by data published in the prestigious journal Diabetes, Obesity and Metabolism. The therapy delays the onset of type 1 diabetes symptoms and works for up to 12 years after its completion without causing serious side effects. The study results show a significant advantage of PolTREG therapy compared to currently used therapies in the treatment of diabetes. The prestigious journal “Diabetes, Obesity and Metabolism”, which sets trends in diabetes treatment, has published an article summarizing the analysis of clinical data confirming the long-term safety and effectiveness of autologous TREGs developed by PolTREG used in the treatment of type 1 diabetes. The study clearly demonstrated that the therapy delays the onset of type 1 diabetes symptoms and is effective for up to 12 years after treatment ends. This is the longest published follow-up report of patients with type 1 diabetes treated with TREGs and an important step in this field. It demonstrates that a well-formulated TREG product can provide lasting immune balance and help preserve beta-cell function long after treatment ends. “The power of TREG cells in treating autoimmune diseases has been confirmed by the results of our research. Their discovery was also recognized and recognized with a Nobel Prize this year. The results of the analysis of our study on the treatment of type 1 diabetes with TREG cells are spectacular; these are the best results that could have been expected. The publication of this article culminates the research process and opens up completely new possibilities for us. This is data we have been collecting for years, but only this year did we have statistics that opened further doors for us and attracted the attention of world-renowned scientists who became involved in PolTREG and began ongoing collaboration with us. I would like to thank the parents and our patients who participated in the study when they were young children. For the entire research team, there is no greater reward than confirmation that in the research group—those young adults who were given the therapy developed by PolTREG years ago—we have halted the progression of the disease. The process of the abnormal immune response attacking their own organs has been halted, and their pancreases continue to secrete insulin,” says Prof. Piotr Trzonkowski, President of the Management Board of PolTREG SA. In the study, conducted by the Medical University of Gdańsk and PolTREG, patients were monitored for 7.5 to 12 years after receiving autologous TREG lymphocytes in childhood. The full open-access article in the journal Diabetes, Obesity and Metabolism is available here:https://dom-pubs.pericles-prod.literatumonline.com/doi/10.1111/dom.70330The analysis described in this article included 51 participants who participated in the PolTREG clinical trial as children. These are now adults, with 7.5 to 12 years having passed since receiving TREG cells or standard therapy. Analysis of over 700 indicators demonstrated the safety of this therapy: no serious adverse events, no tumors, and no safety issues. At the same time, long-term clinical benefits were clearly demonstrated: higher C-peptide levels, longer remission, and insulin independence compared to standard therapy. The best results were achieved with the Treg lymphocyte + anti-CD20 antibody treatment regimen. “This prestigious journal, with its wide reach and authority, ensures that the results published there will reach a large audience in the world of medicine and business and strengthen our position in both environments. Doctors and patients have been waiting for this very therapy, which inhibits the autoimmune process of destruction of insulin-producing cells, for over a hundred years. The drug Tzield has brought about a huge change in thinking about early detection and treatment of diabetes, but our therapy looks even more promising. Evidence of the safety and effectiveness of our therapy in a group of patients with symptoms of type 1 diabetes allowed us to obtain approval from the EMA and initially from the FDA to conduct a clinical trial in the first stage of this disease, when the disease process is still latent and many years will pass before symptoms appear. If the published results are so positive in patients who have retained the function of only 10-20% of insulin-producing cells, we can expect them to be spectacular when these cells still have 80-90%. Furthermore, in these children, often as young as 3 years old and generally considered healthy, natural cells in an autologous model are therapy of choice. It is difficult to expect the EMA or FDA to approve genetically modified cell therapy before it has proven its effectiveness, and above all, its safety, in adult or symptomatic patients. This gives us a huge advantage over potential competitors, who will not have such results for a long time. That is why we are seeing such strong interest in the US, where the best scientific and clinical centers are located and where our competitors operate. As a result, PolTREG is ready to enter the US. We established a local subsidiary, Immuthera, in the US and began intensive collaboration with the most important global opinion leaders in the field of diabetes. They considered our results groundbreaking and supported us in preparing the meeting with the FDA, which so positively impacted the prospects of registering our therapy in the US. Already at the pre-IND stage, we received a suggestion that the study conducted in the US would be the registration study, and the results from the study currently conducted in Poland would be included in the statistics considered by the FDA. This entire sequence of events puts us in a completely new place in terms of the company’s business strategy and means that New opportunities are opening up for us. Considering that the pharmaceutical company paid almost USD 3 billion for the rights to Teplizumab, we are counting on interest in our therapy from businesses,” emphasizes Mariusz Jabłoński, member of the management board of PolTREG SA. Diabetes is a currently incurable and devastating disease – it is the leading cause of blindness, kidney failure, heart attacks, strokes, and lower limb amputations. It ranks seventh among the leading causes of death worldwide. Only in 2022, the drug Tzield (Teplizumab) was approved, for now exclusively in the US. It was the first treatment for type 1 diabetes, delaying the progression of the disease by 2-3 years. At the same time, the treatment process involves a difficult hospitalization, lasting several or even several dozen days, and additionally, it exposes patients to toxicity and severe side effects. Despite certain shortcomings, Teplizumab was acquired by an international pharmaceutical company for nearly $3 billion. *** 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: https://poltreg.com/pl/ 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/