PolTREG identifies a promising efficacy biomarker for type 1 diabetes in patients treated with its Treg therapy in combination with rituximab

• A new biomarker may facilitate health monitoring of T1D patients
• Increase in PD-1+ T cells correlated with therapeutic response and lower insulin use

Gdansk, Poland”, 4 April 2024 “ PolTREG SA (Warsaw Stock Exchange: PTG), a clinical-stage biotechnology company developing cell therapies for a range of autoimmune diseases, today announces that it has published data in International Immunopharmacology suggesting that PD-1+ T cells are a robust biomarker for efficacy in pediatric patients with early-onset type 1 diabetes (T1D), who had been successfully treated with Treg cell therapy PTG-007, the company’s lead asset. The new findings come from a two-year follow-up of immune monitoring data from 36 patients who participated in a randomized, placebo-controlled phase 1/2 clinical trial. This three-arm study previously showed that 50% of patients treated with PTG-007 in combination with rituximab were still in remission after 24 months.

Piotr Trzonkowski, CEO of PolTREG, co-author of the peer-reviewed study, said: This peer-reviewed scientific publication adds to our growing excitement about the potential of polyclonal Treg therapies. Over the past 17 years we have treated over 100 patients with our cell therapy at our facility. This has given us a wealth of data and unrivaled experience in how T1D and other autoimmune diseases respond to various treatments, including our polyclonal Treg cell therapies and, starting next year, engineered Treg therapies. Having a biomarker of efficacy, such as PD-1+ T cells, could facilitate doctors’ ability to monitor patients’ responses to therapy. We already use this data to build new cellular products and design upcoming trials towards marketing authorization. This demonstrates the strength of our unique approach of using the experience gained from working with patients as the basis for building our portfolio.

The main finding of the Phase 1/2 study, the results of which were published in 2022, was that combined treatment with autologous regulatory T cells (Tregs) and rituximab is superior to monotherapy in T1D. The current study aimed to evaluate the immune profile in patients by creating immunophenotypes of Treg, effector and T cells, trying to correlate them with clinical and biomarker outcomes. The main results were the following:

• A clinical response in T1D to treatment with polyclonal Treg cells and rituximab is associated with increased percentages of PD-1+ T cells (both T-reg cells and T-effector cells) and remodeled humoral immunity
• Increased levels of PD-1+ T cells correlate with treatment success and should be confirmed through further studies as a biomarker of efficacy
• Higher expression of the PD-1 receptor on T cells also correlates with a better response in patients, such as the need for a lower daily dose of insulin.
• Tracking PD-1+ T cells may allow immune monitoring of therapy

PolTREG holds one of the most advanced pipelines for Treg therapies for autoimmune diseases, developing both polyclonal and engineered cells. Its lead candidate, PTG-007, an autologous polyclonal Treg treatment, is in mid-stage clinical trials for T1D and multiple sclerosis (MS). Next year, PolTREG plans to launch first-in-human trials of its engineered CAR-Tregs to treat two neurodegenerative diseases: MS and amyotrophic lateral sclerosis (ALS). The company is also in preclinical development with two additional types of engineered Treg cells.

PolTREG manufactures all of its Treg therapies at its wholly owned GMP certified manufacturing facility. It is the first company in the world to administer T-reg therapies to patients and, with a valid hospital exemption in Poland, the first to start receiving revenue from a Treg therapy for autoimmune diseases. Its GMP manufacturing facility is one of the largest and most advanced in Europe and boasts over 2,100 m² of laboratory space, including 15 production lines. PolTREG has the ability to substantially expand the facility to accommodate the manufacturing of engineered therapies and next-generation cell therapies by future partners.

From PolTREGPolTREG is a global leader in the development of autoimmune therapies based on T-regulatory cells (Tregs). Its lead product, PTG-007, an autologous Treg treatment for early-onset type 1 diabetes (T1D) is ready for Phase 2/3 clinical trials, for which the company is seeking a partnership. The company will initiate Phase 2 studies for PTG-007 for the treatment of multiple sclerosis (MS) in the second half of 2024, for RRMS and PPMS. PolTREG has also engineered Tregs, including CAR-Tregs, antigen-specific Tregs, and TCR-Tregs, into the preclinical stage. PolTREG has completed four clinical studies with more than 100 patients treated with Tregs.

For further information, visit www.polleg.com.

Important informationThe contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements.” These forward-looking statements can be identified by the use of forward-looking terminology, including the words “believes”, “estimates”, “anticipates”, “expects”, “intends”, “may”, “will”, “plans”. , “continue”, “ongoing”, “potential”, “expect”, “project”, “objective”, “seek” or “should” and include statements made by the Company regarding the expected results of its strategy. nature, forward-looking statements involve risks and uncertainties, and readers are cautioned that such forward-looking statements are not guarantees of future performance. The Company’s actual results may differ materially from those anticipated by the forward-looking statements. The Company undertakes no obligation to update or publicly review forward-looking statements, except as required by law.

• 20240404 PolTREG PR article INTIMP – final

Source: PolTREG SA