Polish biotechnology company PolTREG S.A. has established a wholly owned U.S. subsidiary, Immuthera, in Delaware and submitted a Pre-IND application to the FDA as part of its strategic expansion into the American market for T-regulatory cell therapies targeting autoimmune diseases.
The company announced that it submitted its Pre-IND meeting request to the FDA in mid-May, marking a significant milestone in bringing its cellular therapy platform to U.S. patients. PolTREG has partnered with Kinexum Services LLC for strategic advisory services regarding Immuthera's interactions with the FDA and registration of TREG therapies in the United States.
EMA Pediatric Committee Endorses Type 1 Diabetes Therapy
In a parallel regulatory development, the Paediatric Committee (PDCO) of the European Medicines Agency issued a positive opinion on PolTREG's Pediatric Investigation Plan (PIP) for PTG-007, an investigational somatic cell therapy product consisting of polyclonal Treg lymphocytes aimed at preventing symptomatic type 1 diabetes in children.
The PDCO's positive opinion is based on PolTREG's original preTreg clinical trial protocol, which was initiated in October 2024 and enrolls children aged 6-16 years with Stage 1 type 1 diabetes. Notably, the committee recommended broadening the eligible population to include patients aged 3-18 years, suggesting that the agency believes this therapy demonstrates exceptional safety.
"This positive opinion paves the way for potential marketing authorization in the EU," the company stated, highlighting the regulatory pathway for PTG-007 in European markets.
Comprehensive Cell Therapy Platform
PolTREG has developed a robust platform encompassing multiple cellular therapy approaches, including polyclonal TREG, CAR-TREG, allogeneic TREG, antigen-specific TREG, and TCR-TREG therapies. The company has also incorporated mRNA immunotherapies into its pipeline, all informed by clinical experience.
"Over recent years, PolTREG has created a platform for the development of multiple cellular therapies: polyclonal Tregs, CAR-TREGs, multi-edited/allogeneic CAR-Tregs, antigen-specific Tregs, and mRNA immunotherapies, all informed by our clinical experience," said Prof. Piotr Trzonkowski, CEO of PolTREG.
The company's lead product, PTG-007, is an autologous Treg treatment for early-onset Type-1 Diabetes that is ready for Phase 2/3 clinical testing, for which the company is seeking a partnership.
Manufacturing Capabilities and Market Position
PolTREG operates its own GMP-certified manufacturing facility, described as one of Europe's largest and most advanced, boasting over 2,100 sqm of laboratory space with 15 production lines. The company holds the distinction of being the first company worldwide 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.
The facility can ship its wide range of cellular therapy products across Europe within 24 hours and has the option to substantially expand to accommodate manufacturing of next-generation engineered therapies and cell therapies.
Strategic Partnerships and Market Development
To support its U.S. expansion, PolTREG has established partnerships with several entities, including Noble Capital Markets, Inc., for strategic and financial advisory services, and formed a strategic cooperation with Swiss company Antion Biosciences to develop the next generation of allogeneic TREG therapies.
The company is currently in discussions with leading American academic and clinical centers to establish collaborations and evaluate new technologies. Immuthera has begun building a Scientific Advisory Board comprised of globally recognized leaders in autoimmune and neuroinflammatory disease.
Immuthera will have full access to PolTREG's Research and Development capabilities along with the ability to explore novel modalities developed by U.S. institutions. The subsidiary is currently seeking investment to pursue the manufacture and clinical development of these assets in the United States and Canada.
