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.