China patent notification boosts PolTREG’s development of Treg cell therapy in multiple sclerosis

• China’s National Intellectual Property Administration has issued notification to grant patent to PolTREG
• Chinese patent covers intrathecal administration of PolTREG’s PTG-007 Treg cell therapy to treat multiple sclerosis
• Intrathecal administration demonstrated promising result in Phase I clinical trial
• PolTREG set to launch one Phase 2 study in each of two types of MS: relapsing-remitting (RRMS) and primary progressive (PPMS) in Q4 2024

Gdańsk, Poland – 16 September 2024 – PolTREG S.A. (Warsaw Stock Exchange: PTG) , a clinical-stage biotechnology company developing cellular therapies for a range of autoimmune diseases, 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.

“We are about to launch two new clinical studies with PTG-007 in patients with multiple sclerosis, so it is welcome news that China has issued us a patent for the intrathecal  administration of the therapy. This method has shown superior results to systemic administration in our earlier work in neurodegenerative diseases, as it bypasses the blood-brain barrier. Having just presented our unrivalled long-term data in type 1 diabetes patients treated with systemically administered PTG-007, we will continue to highlight the potential of Treg cell therapies in a widening range of autoimmune diseases, including neurodegenerative diseases like MS and Amyotrophic Lateral Sclerosis,” said Prof Piotr Trzonkowski, CEO of PolTREG.

In an exploratory Phase 1/2a safety study of PTG-007 in RRMS, patients who had received intrathecal administration showed no increase in existing lesions in the brain, and almost no new lesions, a far superior result compared to patients who had received PTG-007 intravenously, and a surprisingly positive signal for such a small study in 14 individuals, only 3 of whom received intrathecal administration. Two large studies to be launched in Poland later this year will aim to confirm these encouraging results. The studies will have a combined 105 patients: 60 for PPMS and 45 for RRMS. Each trial will have three arms, with primary endpoints a reduced deterioration in new and existing lesions, and the number of serious adverse events.