PTG-007 / PolTREG - LARVOL DELTA

Positive EMA Opinion on Pediatric Investigation Plan for PolTREG’s Treg Therapy in Type 1 Diabetes (GlobeNewswire) - "PolTREG S.A...announces that the Paediatric Committee (PDCO) of the European Medicines Agency has issued a positive opinion on the Pediatric Investigation Plan (PIP) for its investigational somatic cell therapy product, polyclonal Treg lymphocytes (PTG-007), aimed at preventing symptomatic type 1 diabetes in children....The PDCO’s positive opinion is based on PolTREG’s original preTreg clinical trial protocol initiated in October 2024, which enrolled children aged 6–16 years in Stage 1 type 1 diabetes. In its assessment, the committee has recommended broadening the eligible population to include patients aged 3–18 years."

European regulatory • Type 1 Diabetes Mellitus

China patent notification boosts PolTREG’s development of Treg cell therapy in multiple sclerosis (GlobeNewswire) - "PolTREG S.A...today announces that China’s National Intellectual Property Administration, PRC (CNIPA) has issued a notification to grant a patent for the intrathecal administration of the company’s cellular therapies in patients with multiple sclerosis (MS). The intrathecal administration is an established method used to deliver a therapy across the blood-brain barrier via injection into the subarachnoid space...PolTREG is preparing to launch a Phase 2 study in presymptomatic T1D patients during the fourth quarter and, next year, PolTREG expects to start a first-in-human trial of its engineered CAR-Treg, using the proven PTG-007 platform, for treatment of MS and amyotrophic lateral sclerosis."

New P2 trial • Patent • Amyotrophic Lateral Sclerosis • CNS Disorders • Immunology • Multiple Sclerosis