Latest news with #PiotrTrzonkowski
Business Upturn
04-08-2025
- Health
- Business Upturn
PolTREG Doses First Patient in Phase II Trial for Pre-Symptomatic Type 1 Diabetes with PTG-007
By GlobeNewswire Published on August 4, 2025, 23:31 IST PolTREG Doses First Patient in Phase II Trial for Pre-Symptomatic Type 1 Diabetes with PTG-007 PTG-007, an autologous cell therapy will be administered to 150 high-risk children aged 3–18, including a placebo-controlled arm. A parallel study presented to FDA and to be conducted by Immuthera has been received favorably, may include Polish patients in the U.S. Statistical analysis, and could be treated as pivotal. The project has received an $11.3 million non-dilutive grant from the Polish Medical Research Agency. PolTREG is developing Multi-edited, Allogeneic CAR-Tregulatory cell therapies which can be used to treat patients diagnosed with T1D (Stage 3), which, in combination with PTG-007 in Stage 1 and Stage 2, will provide clinical solutions for patients across all Stages of T1D. 4 August 2025 – PolTREG S.A. (Warsaw Stock Exchange: PTG), a pioneer in cell therapies for autoimmune diseases, and its U.S. subsidiary Immuthera, announced that they have administered the first dose of PTG-007 to a patient in their Phase II clinical trial for pre-symptomatic type 1 diabetes. The trial, called 'Pre-Treg' will enroll up to 150 genetically high-risk children and adolescents (aged 3–18) who have not yet developed clinical symptoms of the disease. If successful, PolTREG aims to develop and register the world's first therapy to prevent the onset of type 1 diabetes symptoms. The company has proposed a parallel study to Pre-Treg to the U.S. Food and Drug Administration (FDA) in a recent Pre-IND meeting. The FDA's response was that the U.S. Trial could potentially be registrational. Further, patients enrolled in Poland at Stage 1 of the disease may, upon completion of enrollment, be included in the U.S. statistical analysis of the study. 'Long-term data from our clinical program of PTG-007 in symptomatic type 1 diabetes confirm both the safety and efficacy of the therapy. Modern medicine is increasingly focusing on interventions applied earlier or even before the first clinical symptoms appear. Our therapy fits perfectly into this paradigm. By administering it at the earliest stage of disease development, we anticipate highly promising outcomes—possibly even halting disease progression before clinical symptoms emerge. If the trial confirms the therapy's efficacy, we have the opportunity to develop and register the world's first drug to prevent the clinical onset of type 1 diabetes. We believe this therapy holds significant market and partnership potential' – said Prof. Piotr Trzonkowski, CEO and Co-Founder of PolTREG S.A. The Phase II study will include 150 participants in a randomized, placebo-controlled design. Recruitment is ongoing at three academic centers in Poland, with six additional clinical hospitals set to begin enrollment shortly. PolTREG has been awarded a non-dilutive grant of PLN 31.7 million (approx. $11.3 million) from the Polish Medical Research Agency to support the execution of this Phase II trial. PreTreg is one of PolTREG's flagship programs. In type 1 diabetes, the autoimmune destruction of insulin-producing pancreatic islets underscores the importance of early intervention. In the pre-symptomatic phase, a sufficient number of islets remain to maintain normal glucose regulation, and the autoimmune process is still limited and more readily controllable. Preventive therapy at this stage could halt the autoimmune attack, leaving patients genetically predisposed but clinically healthy for life. Upon successful completion of this trial and confirmation of safety and efficacy, PolTREG could establish the first approved drug to prevent symptomatic type 1 diabetes. Type 1 diabetes progresses through three stages. Stages 1 and 2 is considered presymptomatic and occurs in young children, typically 3 years old or older. Because these patients are not yet sick, safety is the highest priority. PTG-007's 12 year safety data makes it an ideal treatment for this age group and this stage of disease. Diagnosis of Type 1 Diabetes occurs in Stage 3 when symptoms occur which can lead to potentially life threatening complications such as diabetic ketoacidocis, heart and blood vessel disease, nerve damage, eye damage, kidney disease, and foot damage. These patients are typically older and require supplemental insulin. Due to the complications in Stage 3, more aggressive treatments are warranted. PolTREG and Immuthera are developing Tregulatory cell therapies that have clinically derived edits to improve function, modifications to make them 'off-the-shelf' (allogeneic), and a Chimeric Antigen Receptor to improve targeting of the disease causing cells that drive the autoimmune response. Taken together, PolTREG and Immuthera have a pipeline of Tregulatory cell therapies that will cover the full spectrum of presymptomatic and symptomatic Type 1 Diabetes. PolTREG is also expanding its U.S. presence. In mid-June, the company established its wholly owned U.S. subsidiary, Immuthera, registered as a Delaware C Corporation. In recent weeks, prominent experts in diabetes and neuroimmunology—Prof. Jay Skyler, Prof. Desmond Schatz, and Prof. Lawrence Steinman—joined the company's Scientific Advisory Board. In late July, PolTREG received the formal outcome of its pre-IND meeting with the FDA and is now preparing its IND submission. The company has partnered with Noble Capital Markets, Inc. and Kinexum Services LLC to support its U.S. regulatory strategy, and is collaborating with Swiss-based Antion Biosciences to develop next-generation allogeneic Treg therapies. About PolTREG: PolTREG 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. PolTREG has established a robust platform encompassing a wide range of cell therapy approaches, including polyclonal TREG, CAR-TREG, allogeneic TREG, antigen-specific TREG, and TCR-TREG therapies. About Immuthera: Immuthera is pioneering novel cell-based therapies for clinical development in the United States and Canada. Immuthera will be clinically developing assets initially developed by PolTREG under the US FDA regulatory framework. Immuthera will have full access to PolTREG's Research and Development capabilities and asset pipeline along with the ability to explore novel modalities developed by US Institutions. Immuthera is currently seeking investment to pursue the manufacture and clinical development of these assets in the United States. For further information please contact: PolTREG Piotr TrzonkowskiChief Executive Officer [email protected] +48 512 532 401 Important information The contents of this announcement include statements that are, or may be deemed to be, 'forward-looking statements'. These forward-looking statements can be identified by the use of forward-looking terminology, including the words 'believes', 'estimates,' 'anticipates', 'expects', 'intends', 'may', 'will', 'plans', 'continue', 'ongoing', 'potential', 'predict', 'project', 'target', 'seek' or 'should', and include statements the Company makes concerning the intended results of its strategy. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The company's actual results may differ materially from those predicted by the forward-looking statements. The company undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law. Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash GlobeNewswire provides press release distribution services globally, with substantial operations in North America and Europe.
Yahoo
13-06-2025
- Business
- Yahoo
PolTREG Establishes U.S. Subsidiary Immuthera to Advance International Development Strategy
PolTREG Establishes U.S. Subsidiary Immuthera to Advance International Development Strategy PolTREG established Immuthera ( in Delaware to expand its presence in the U.S. market. A Pre-IND application was submitted to the FDA. The Paediatric Committee (PDCO) of the European Medicines Agency issued a positive opinion on PolTREG's Pediatric Investigation Plan (PIP) for PTG-007 in pre-symptomatic type 1 diabetes (Stage 1). Gdańsk, Poland – 13 JUNE 2025 – PolTREG S.A. (Warsaw Stock Exchange: PTG), a clinical-stage biotechnology company developing cellular therapies for a range of autoimmune diseases, announces that it has established a wholly owned subsidiary, Immuthera, a United States C Corporation, in the state of Delaware. This is a further step by PolTREG to deepen its entry into the U.S. market. 'Over recent years, PolTREG has created a platform for the development of multiple cellular therapies: polyclonal Tregs, CAR-TREGs, mulit-eidited/allogeneic CAR-Tregs, antigen-specific Tregs, and mRNA immunotherapies, all informed by our clinical experience. To fully leverage our potential, we are focusing on the execution our growth strategy in the American market by systematically bringing existing therapies, and exploring new assets into the US. We have established partnerships with several renowned entities such as Noble Capital Markets, Inc., for strategic and financial advisory services. We have also formed a strategic cooperation with the Swiss company Antion Biosciences to develop the next generation of allogeneic TREG therapies' said Prof. Piotr Trzonkowski, CEO of PolTREG. 'This expands PolTREG's project pipeline and enhances the company's attractiveness to potential strategic partners. Additionally, we with the U.S. company Kinexum Services LLC for strategic advisory regarding Immuthera's interactions with the FDA and the registration of TREG therapies in the United States. We submitted our Pre-IND meeting request to the FDA in mid-May,' added Prof. Piotr Trzonkowski. PolTREG is currently in discussions with leading American academic and clinical centers to establish collaborations and evaluate new technologies Immuthera has also begun the process of building a world-class Scientific Advisory Board comprised of globally recognized leaders in the Autoimmune and Neuroinflammatory disease. In support of PolTREG and the launch of Immuthera, Dr. Dan Shelly, Chief Business Development Officer, and Dr. Mariusz Jablonski, Chief Business Officer, will participate in the upcoming BIO International Convention 2025, taking place from June 16–19 in Boston. At BIO Drs. Shelly and Jablonski will be promoting PolTREG's current clinical and developmental pipeline while also speaking to potential partners, collaborators, and investors for Immuthera. In May, the Paediatric Committee (PDCO) of the European Medicines Agency issued a positive opinion on the Pediatric Investigation Plan (PIP) for PolTREG's investigational somatic cell therapy product, polyclonal Treg lymphocytes (PTG-007), which is aimed to prevent symptomatic type 1 diabetes in children. The PDCO's positive opinion is based on PolTREG's original preTreg clinical trial protocol, initiated in October 2024, enrolling children aged 6–16 years with Stage 1 type 1 diabetes. In its assessment, the committee recommended broadening the eligible population to include patients aged 3–18 years suggesting that the agency believes this therapy is extremely safe. This positive opinion paves the way for potential marketing authorization in the EU. To read more about the clinical trials PolTREG has completed, please click on: PolTREG manufactures its Treg therapeutics at its own GMP-certified manufacturing facility. It is the first company in the world to have administered Treg therapies to patients, and, under a hospital exemption valid in Poland, the first company to start receiving revenues from a Treg therapeutic for autoimmune disease. Its GMP manufacturing facility is one of Europe's largest and most advanced, boasting over 2,100 sqm of laboratory space, including 15 production lines. PolTREG has the option to substantially expand the facility to accommodate manufacturing of next-generation engineered therapies and cell therapies. It can ship its wide range of cellular therapy products across Europe within 24 hours. About PolTREG PolTREG 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. PolTREG has established a robust platform encompassing a wide range of cell therapy approaches, including polyclonal TREG, CAR-TREG, allogeneic TREG, antigen-specific TREG, and TCR-TREG therapies. About Immuthera Immuthera is pioneering novel cell-based therapies for clinical development in the United States and Canada. Immuthera will be clinically developing assets initially developed by PolTREG under the US FDA regulatory framework. Immuthera will have full access to PolTREG's Research and Development capabilities along with the ability to explore novel modalities developed by US Institutions. Immuthera is currently seeking investment to pursue the manufacture and clinical development of these assets in the United States. For more information please visit For further information please contact:PolTREG Piotr TrzonkowskiChief Executive Officerir@ 512 532 401 Important information The contents of this announcement include statements that are, or may be deemed to be, "forward-looking statements". These forward-looking statements can be identified by the use of forward-looking terminology, including the words "believes", "estimates," "anticipates", "expects", "intends", "may", "will", "plans", "continue", "ongoing", "potential", "predict", "project", "target", "seek" or "should", and include statements the Company makes concerning the intended results of its strategy. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The company's actual results may differ materially from those predicted by the forward-looking statements. The company undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law.
Yahoo
15-05-2025
- Health
- Yahoo
Positive EMA Opinion on Pediatric Investigation Plan for PolTREG's Treg Therapy in Type 1 Diabetes
Positive EMA Opinion on Pediatric Investigation Plan for PolTREG's Treg Therapy in Type 1 Diabetes The Paediatric Committee (PDCO) of the European Medicines Agency issues positive opinion on PolTREG's Pediatric Investigation Plan (PIP) for PTG-007 in pre-symptomatic type 1 diabetes (Stage 1). Positive opinion paves the way for potential marketing authorization in the EU and EEA. Recommendation to expand pediatric indication to ages 3–18 years (originally 6–16 years). In vivo data in murine models confirm preliminary safety and efficacy of CAR-TREG therapy, supporting upcoming Phase 1 clinical trials in multiple sclerosis and amyotrophic lateral sclerosis. Gdańsk, Poland – 15 May 2025 – PolTREG S.A. (Warsaw Stock Exchange: PTG) , a clinical-stage biotechnology company developing cellular therapies for a range of autoimmune diseases, announces that the Paediatric Committee (PDCO) of the European Medicines Agency has issued a positive opinion on the Pediatric Investigation Plan (PIP) for its investigational somatic cell therapy product, polyclonal Treg lymphocytes (PTG-007), aimed at preventing symptomatic type 1 diabetes in children. 'Securing a positive opinion from the PDCO brings PolTREG one step closer to the potential approval of PTG-007 for pediatric use across the European Union and the European Economic Area. Achieving the PIP-defined clinical endpoints may serve as the basis for obtaining marketing authorization. Pre-symptomatic type 1 diabetes (Stage 1) represents a significant unmet medical need, making this therapeutic area highly attractive,' said Prof. Piotr Trzonkowski, CEO of PolTREG. 'We are also delighted by the progress in developing next-generation Tregs. The in vivo murine results obtained a few days ago using CAR-TREG lymphocytes shows the preliminary safety and efficacy of our therapy. In the coming months, we will intensively prepare to initiate a Phase 1 clinical trial in multiple sclerosis and amyotrophic lateral sclerosis,' said Prof. Piotr Trzonkowski. The PDCO's positive opinion is based on PolTREG's original preTreg clinical trial protocol initiated in October 2024, which enrolled children aged 6–16 years in Stage 1 type 1 diabetes. In its assessment, the committee has recommended broadening the eligible population to include patients aged 3–18 years. PolTREG combines over 12 years of clinical data confirming the safety and efficacy of polyclonal Treg therapies with a broad portfolio of next-generation technologies, including allogeneic Tregs, CAR-TREGs, antigen-specific Tregs, and TCR-TREGs. PolTREG is the only company with 12 years' worth of patient-safety and efficacy data for autologous polyclonal Treg therapies—data derived from clinical trials and hospital exemptions in Poland. To read more about the clinical trials PolTREG has completed, please click on: In parallel, PolTREG has achieved a major milestone toward its CAR-TREG program, in collaboration with AZTherapies. In vivo studies in murine models demonstrate encouraging preliminary safety and efficacy for CAR-engineered Treg lymphocytes, supporting an application for a Phase 1 clinical trial in multiple sclerosis and Amyotrophic Lateral Sclerosis in the coming months. This cellular product will be further made allogeneic in the cooperation with Swiss-based company Antion manufactures its Treg therapeutics at its own GMP-certified manufacturing facility. It is the first company in the world to have administered Treg therapies to patients, and, under a hospital exemption valid in Poland, the first company to start receiving revenues from a Treg therapeutic for autoimmune disease. Its GMP manufacturing facility is one of Europe's largest and most advanced, boasting over 2,100 sqm of laboratory space, including 15 production lines. PolTREG has the option to substantially expand the facility to accommodate manufacturing of next-generation engineered therapies and cell therapies. It can ship its wide range of cellular therapy products across Europe within 24 hours. About PolTREG PolTREG 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. PolTREG has established a robust platform encompassing a wide range of cell therapy approaches, including polyclonal TREG, CAR-TREG, allogeneic TREG, antigen-specific TREG, and TCR-TREG therapies. For more information please visit For further information please contact:PolTREG Piotr TrzonkowskiChief Executive Officerir@ 512 532 401 Important information The contents of this announcement include statements that are, or may be deemed to be, "forward-looking statements". These forward-looking statements can be identified by the use of forward-looking terminology, including the words "believes", "estimates," "anticipates", "expects", "intends", "may", "will", "plans", "continue", "ongoing", "potential", "predict", "project", "target", "seek" or "should", and include statements the Company makes concerning the intended results of its strategy. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The company's actual results may differ materially from those predicted by the forward-looking statements. The company undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law.
