PolTREG's PTG-007 therapy shows long-term safety and efficacy for type-1 diabetes

In GDANSK, Poland, on June 24, 2024, PolTREG S.A. (Warsaw Stock Exchange: PTG), a biotechnology firm specializing in cellular therapies for autoimmune diseases, revealed promising results from its long-term study of PTG-007. The study demonstrated that the polyclonal Treg cell therapy significantly restored insulin secretion and extended disease remission in early-onset type-1 diabetes (T1D) patients compared to those receiving standard care. This clinical study, which spanned 7 to 12 years, focused on pediatric patients treated with the autologous therapy.

Key findings from the study confirmed the long-term efficacy of PTG-007, building on positive results from earlier Phase 1/2 clinical trials. According to Prof. Piotr Trzonkowski, CEO of PolTREG, the outcomes suggest that PTG-007 could potentially prevent T1D, alleviating the need for patients to undergo frequent insulin injections and reducing the risk of long-term complications associated with the disease.

PolTREG's study also satisfied a European Medicines Agency requirement to demonstrate the safety of Treg therapies at least five years post-administration. This positions PolTREG uniquely, as no other company has provided comparable long-term safety data for Treg therapy in T1D. This advantage is expected to facilitate the initiation of a pivotal Phase 2/3 study for PTG-007 aimed at treating T1D.

The company is actively seeking funding partners to support this critical trial, which is essential before regulatory approval for commercialization can be pursued. PolTREG plans to submit its findings for peer-reviewed publication soon. Additionally, Prof. Trzonkowski announced the launch of a Phase 2 study later this year targeting presymptomatic children identified as having a high risk for developing diabetes.

PolTREG boasts one of the most comprehensive pipelines for Treg therapies addressing autoimmune diseases, with both polyclonal and engineered therapies in development. PTG-007, the flagship autologous polyclonal Treg therapy, is currently in mid-stage clinical development for T1D and multiple sclerosis (MS). In the upcoming year, the company intends to commence first-in-human trials of its engineered CAR-Tregs, designed to treat neurodegenerative diseases like MS and amyotrophic lateral sclerosis (ALS). PolTREG also has several other engineered Treg cell types in preclinical development.

The company manufactures its Treg therapeutics in-house at a GMP-certified facility, which is among the largest and most advanced in Europe. This facility spans over 2,100 square meters and includes 15 production lines. PolTREG's facility is positioned to scale up for next-generation engineered therapies and cell therapies. It can distribute cellular therapy products across Europe within 24 hours.

PolTREG remains a forerunner in the field of autoimmune therapies utilizing T-regulatory cells (Tregs). Their primary product, PTG-007, is advancing towards Phase 2/3 clinical testing for early-onset T1D, for which the company seeks partnership support. The firm is also preparing to launch Phase 2 trials for PTG-007 to treat various forms of multiple sclerosis (MS) in the latter half of 2024. Moreover, PolTREG is advancing its preclinical programs, including CAR-Tregs and other antigen-specific Tregs. To date, PolTREG has completed four clinical trials involving over 100 patients treated with Treg therapies.