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 (https://immuthera.bio/) 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: https://poltreg.com/tregs-therapy/#publications

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 www.poltreg.com

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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