Positive EMA Opinion on Pediatric Investigation Plan for PolTREG’s Treg Therapy in Type 1 Diabetes

Core Viewpoint - PolTREG S.A. has received a positive opinion from the European Medicines Agency's Paediatric Committee regarding its Pediatric Investigation Plan for PTG-007, a therapy aimed at preventing symptomatic type 1 diabetes in children, which could lead to potential marketing authorization in the EU and EEA [1][2][8] Group 1: Pediatric Investigation Plan and Clinical Trials - The PDCO's positive opinion is based on PolTREG's clinical trial protocol initiated in October 2024, which originally enrolled children aged 6–16 years, with a recommendation to broaden eligibility to ages 3–18 years [3][8] - Achieving the clinical endpoints defined in the PIP may serve as a basis for obtaining marketing authorization for PTG-007 [2][8] Group 2: Product Development and Safety Data - PolTREG combines over 12 years of clinical data confirming the safety and efficacy of polyclonal Treg therapies, making it the only company with such extensive patient-safety and efficacy data for autologous polyclonal Treg therapies [4][9] - In vivo murine studies have shown preliminary safety and efficacy for CAR-TREG lymphocytes, supporting upcoming Phase 1 clinical trials in multiple sclerosis and amyotrophic lateral sclerosis [2][5][8] Group 3: Manufacturing and Expansion Capabilities - PolTREG operates a GMP-certified manufacturing facility, one of Europe's largest, with over 2,100 sqm of laboratory space and 15 production lines, allowing for the production of Treg therapeutics [6][7] - The company has the option to expand its facility to accommodate next-generation engineered therapies and can ship its cellular therapy products across Europe within 24 hours [7]