PolTREG Cell Therapy Receives Positive EMA Opinion for Pediatric Type 1 Diabetes Therapy

May 15 , 2025

Gdańsk, Poland – 15 May 2025 Polish biotech PolTREG announced the European Medicines Agency’s Paediatric Committee PDCO issued a positive opinion on its Pediatric Investigation Plan (PIP) for PTG-007, a polyclonal Treg lymphocyte therapy aimed at preventing symptomatic type 1 diabetes in children.

CEO Prof. Piotr Trzonkowski sees this as a step towards potential EU approval for pediatric use, noting the unmet need in pre-symptomatic type 1 diabetes. The PDCO recommended broadening the trial’s age range to 3–18 years, based on PolTREG’s ongoing preTreg trial.

PolTREG highlights its 12 years of clinical data on polyclonal Treg safety and efficacy, alongside its development of next-generation Treg technologies like CAR-TREGs. The company reported promising preclinical CAR-TREG results with AZTherapies, planning a Phase 1 trial in MS and ALS. This CAR-TREG will be made allogeneic with Antion Biosciences.

Source:

https://www.globenewswire.com/news-release/2025/05/15/3081846/0/en/Positive-EMA-Opinion-on-Pediatric-Investigation-Plan-for-PolTREG-s-Treg-Therapy-in-Type-1-Diabetes.html

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