PolTREG S.A. has launched a preclinical study evaluating CAR-Treg cell therapy for neuroinflammatory diseases, marking a significant step toward potential treatments for conditions like multiple sclerosis (MS) and amyotrophic lateral sclerosis (ALS). The study, utilizing a humanized mouse model, aims to determine the safety and efficacy of the CAR-Treg cell therapy, with results anticipated by March 30, 2025. This data will inform the pathway to clinical trials.
Professor Piotr Trzonkowski, CEO of PolTREG, stated, “This first preclinical study of our CAR-Treg cell therapy programme to treat neurodegenerative disease is a significant milestone for PolTREG. This may be our first CAR-Treg cell therapy candidate, but we expect it to benefit tremendously from the experience our team built up during more than a decade in manufacturing, developing and treating patients with PTG-007.”
The CAR-Treg cells used in this study are derived from PolTREG's PTG-007, an autologous Treg treatment currently in Phase II/III clinical testing for early-onset type-1 diabetes. PTG-007 has accumulated 12 years of patient safety and efficacy data. This extensive track record provides a competitive advantage, as the next-generation engineered Tregs share a high degree of bioequivalence with PTG-007, potentially streamlining their development.
Leveraging Existing Expertise
PolTREG's expertise in T-regulatory cell (Treg) therapies for autoimmune diseases positions them favorably in this new endeavor. Their proprietary technology and GMP manufacturing facility in Poland are expected to facilitate the development of these engineered therapies.
Professor Trzonkowski added, “This lengthy track record gives us several competitive advantages, as the next-generation engineered Tregs that we are adding to our pipeline come from the same platform and show a large degree of bioequivalence with PTG-007. Because of our proprietary technology and expertise, we expect to be able to develop our engineered therapies with greater ease than others in this field.”
Future Directions
Following successful completion of the CAR-Treg preclinical testing, PolTREG intends to initiate first-in-human trials of the engineered candidate for the treatment of Multiple Sclerosis (MS) and amyotrophic lateral sclerosis (ALS). In addition to CAR-Tregs, PolTREG is also developing antigen-specific Tregs and T-cell receptor (TCR) Tregs for autoimmune diseases, currently in early proof-of-concept stages.
