**PolTREG Expands Its Reach: The Establishment of Immuthera**
PolTREG S.A., a leading clinical-stage biotechnology company based in Gdańsk, Poland, has made significant strides in its international development strategy with the establishment of Immuthera, a wholly owned subsidiary in Delaware, USA. This strategic move is poised to enhance PolTREG’s presence in the competitive U.S. market, underscoring the company’s commitment to advancing cellular therapies for autoimmune diseases.
**A Firm Foundation for Growth**
On June 13, 2025, PolTREG announced the creation of Immuthera, aimed at expanding its operational footprint in the United States. Significantly, the company has submitted a Pre-Investigational New Drug (Pre-IND) application to the FDA as part of its ambitious plan to engage with U.S. regulatory processes. The establishment of this subsidiary comes after the Pediatric Committee (PDCO) of the European Medicines Agency (EMA) positively reviewed PolTREG’s Pediatric Investigation Plan (PIP) for PTG-007, a therapy targeting pre-symptomatic type 1 diabetes in children.
**Innovative Therapeutic Platforms**
PolTREG is not new to the field of cellular therapies. With a focus on multiple therapeutic platforms, including polyclonal Tregs, CAR-TREGs, and mRNA immunotherapies, the company has built a robust foundation informed by its extensive clinical experience. Prof. Piotr Trzonkowski, the CEO of PolTREG, highlighted the company’s strategy: “We are focusing on executing our growth strategy in the American market by systematically bringing existing therapies and exploring new assets.”
**Strategic Partnerships to Accelerate Development**
Key to PolTREG’s strategy is the formation of strategic partnerships aimed at facilitating entry into the U.S. market. Notable collaborations include Noble Capital Markets, Inc. for advisory services, and Antion Biosciences for the development of next-generation allogeneic TREG therapies. These relationships are designed to augment PolTREG’s project pipeline, making it an attractive partner for potential collaborations.
Additionally, collaboration with Kinexum Services LLC has been established to ensure effective interactions with the FDA as Immuthera navigates regulatory requirements for TREG therapies in the United States.
**Collaboration with U.S. Institutions**
As part of its growth strategy, PolTREG is also engaging leading academic and clinical institutions in the U.S. to evaluate cutting-edge technologies. This initiative aligns with Immuthera’s goal to develop world-class therapeutic options, informed by the latest advancements in the field.
**Participation at BIO International Convention 2025**
In a bid to showcase its innovations and connect with potential investors and partners, Dr. Dan Shelly and Dr. Mariusz Jablonski from PolTREG will represent the company at the BIO International Convention 2025 in Boston. This prominent event offers a platform for promoting PolTREG’s clinical and developmental pipeline while fostering new partnerships.
**Advancements in Pediatric Research**
A landmark moment for PolTREG came in May when the PDCO issued a favorable opinion on the PIP for its investigational therapy PTG-007. Targeted at preventing symptomatic type 1 diabetes in children, this therapy underwent rigorous evaluation, leading to recommendations for broadening its eligible patient demographic. This endorsement signifies confidence in the safety and potential effectiveness of the therapy and paves the way for marketing authorization in the EU.
**A State-of-the-Art Production Facility**
PolTREG sets itself apart with its GMP-certified manufacturing facility, one of Europe’s largest and most advanced. This facility enables the company to produce Treg therapeutics and ship products across Europe within 24 hours. With plans for possible expansion, PolTREG is well-positioned to support the demand for next-generation engineered therapies.
**About PolTREG and Immuthera**
PolTREG is at the forefront of developing autoimmune therapies centered on T-regulatory cells (Tregs). Its lead product, PTG-007, is prepared for Phase 2/3 clinical trials, and the company is actively seeking partnerships to advance its development. Immuthera will focus on bringing novel cell-based therapies to market in the U.S. and Canada, leveraging PolTREG’s R&D capabilities while exploring new modalities through collaborations with American institutions.
For more information on their ongoing clinical trials and further details, visit [PolTREG’s official website](https://poltreg.com/tregs-therapy/#publications).
**Contact Information**
For inquiries, you can reach out to:
PolTREG S.A.
Prof. Piotr Trzonkowski
Chief Executive Officer
ir@poltreg.com
+48 512 532 401
**Forward-Looking Statements**
It’s important to note that this announcement contains forward-looking statements, which are subject to risks and uncertainties. Actual results may differ significantly from those predicted, and the company undertakes no obligation to update or revise these statements, except as required by law.
