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: https://poltreg.com/tregs-therapy/#publications
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 Biosciences.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.
For more information please visit www.poltreg.com.
For further information please contact:PolTREG S.A.Prof Piotr TrzonkowskiChief Executive Officerir@poltreg.com+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.
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