PolTREG and U.S. Subsidiary Immuthera Secure Positive FDA Opinion, Paving the Way for a Registrational Pre-Symptomatic Type 1 Diabetes Trial

PolTREG and U.S. Subsidiary Immuthera Secure Positive FDA Opinion, Paving the Way for a Registrational Pre-Symptomatic Type 1 Diabetes Trial

• FDA agreed that PolTREG’s clinical data in Stage 3 Type 1 Diabetes (T1D) appears sufficient to support the Prospect of Direct benefit in an adaptive Phase 2/3 study of PTG-007 in Stage 1 and Stage 2 Presymptomatic T1D patients.
• The FDA is receptive to the inclusion of Stage 1 Polish patients in the trial’s statistical analyses
• FDA may consider the adaptive Phase 2/3 study as registrational, potentially expediting U.S. approval for PTG-007 in presymptomatic Type 1 diabetes.
• PolTREG and Immuthera will apply for Fast Track, Breakthrough, or Regenerative Medicine Advanced Therapy (RMAT) designation in the IND filing.

31 July 2025 – PolTREG S.A. (Warsaw Stock Exchange: PTG), a pioneer in cell therapies for autoimmune diseases, and its U.S. subsidiary Immuthera announced that the U.S. Food and Drug Administration (FDA) has issued a formal meeting protocol summarizing the recent pre-Investigational New Drug (pre-IND) meeting on the adaptive Phase 2/3 trial of PTG-007 in children with stage 1 and stage 2 presymptomatic Type 1 diabetes. The protocol confirms that the clinical data submitted by PolTREG and Immuthera are sufficient to support an IND application and outlines several regulatory pathways to accelerate U.S. development.

“The FDA’s feedback is exceptionally encouraging. The U.S. regulator has recognized the significant therapeutic potential of our approach, creating a real opportunity for the adaptive Phase 2/3 study to be deemed registrational. Including Stage 1 patients from Poland will meaningfully lower overall costs and accelerate the time to first data readout. Moreover, the pathway to Fast Track, Breakthrough Therapy, or Regenerative Medicine Advanced Therapy designation could substantially streamline and speed our U.S. approval process. By intervening at the earliest stage of disease—often in young children—we expect truly transformative outcomes, potentially halting progression before clinical symptoms emerge. In presymptomatic pediatric patients, autologous TREG cells represent the optimal strategy due to the safety profile and demonstrated efficacy in Stage 3 patients. If successful, PTG-007 would become the world’s first therapy registered at this earliest stage of Type 1 diabetes—a milestone critical for securing strategic partnerships.” - said Prof. Piotr Trzonkowski, CEO of Immuthera and PolTREG.

Key Takeaways from the FDA Protocol:

• The FDA indicated that the general study design (double-blind, four treatment groups, stratification by age and HLA, and quarterly follow-up) is reasonable.
• FDA agrees that, in the proposed study, the potential benefits of treatment outweigh any risks to patients.
• FDA confirms that the clinical data submitted by the Company are sufficient to support an IND application for the proposed U.S. study.
• FDA is open to including Stage 1 patients from Poland in the U.S. trial’s statistical analysis.
• FDA prefers that technology transfer data to the U.S. be included in the IND submission.
• FDA will consider treating the Company’s proposed adaptive Phase 2/3 study as a registrational trial.

In a next step, PolTREG plans to file its formal IND meeting request with the FDA in the coming weeks.

Strengthening U.S. Presence PolTREG has been bolstering its U.S. footprint:

• In mid-June, PolTREG established Immuthera, a 100%-owned Delaware C Corporation.
• In early July, acclaimed diabetes and neuroimmunology experts Prof. Jay Skyler, Prof. Desmond Schatz, and Prof. Lawrence Steinman joined the Company’s Scientific Advisory Board.
• Earlier this year, Noble Capital Markets, Inc. and Kinexum Services LLC came on board to support PolTREG’s U.S. registration efforts.
• PolTREG also initiated a collaboration with Antion Biosciences (Switzerland) to develop next-generation allogeneic TREG therapies.
• PolTREG is developing Multi-edited and Allogeneic CAR-Tregulatory cell therapies which can be used to treat patients diagnosed with T1D (Stage 3), which, in combination with PTG-007 in Stage 1 and Stage 2, will provide clinical solutions for patients across all Stages of T1D.
  
  

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 and asset pipeline 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.

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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