Thursday, 18 April 2024

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

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  • New biomarker may facilitate monitoring T1D patients’ health
  • Increase in PD-1+ T-cells correlated with therapeutic response and less insulin use

GdaÅ„sk, Poland “ 4 April 2024 “ PolTREG S.A. (Warsaw Stock Exchange: PTG) , a clinical-stage biotechnology company developing cellular therapies for a range of autoimmune diseases, today announces it has published data in International Immunopharmacology which suggest that PD-1+ T-cells are a dependable biomarker for efficacy in pediatric early-onset Type-1 diabetes (T1D) patients, who had been successfully treated with PTG-007 Treg cell therapy, the company’s lead asset. The new results are from a two year immune-monitoring data follow-up of 36 patients who had participated in a randomized, placebo-controlled Phase 1/2 clinical trial. This three-arm trial had earlier shown that 50% of PTG-007-treated patients in combination with rituximab were still in remission after 24 months.

PolTREG CEO Piotr Trzonkowski, who co-authored the peer-reviewed study, said: This peer-reviewed scientific publication adds to our growing excitement about the potential of polyclonal Treg therapies. We have treated over 100 patients with our cell therapy at our facility over the last 17 years. This has afforded us a wealth of data and unrivalled experience with how T1D and other autoimmune diseases respond to various treatments, including our polyclonal Treg cell therapies and – starting next year – engineered Treg therapeutics. Having a biomarker of efficacy, like PD-1+ T-cells, could facilitate doctors’ ability to monitor their patients’ responses to therapy. We already use this data to build new cell products and design next trials towards marketing authorisation. It shows the strength of our unique approach of using the experience from working with patients as the basis to build our portfolio.

The main finding of the Phase 1/2 study, results of which were published in 2022, was that combined treatment with autologous T-regulatory cells (Treg) and rituximab is superior to monotherapy in T1D. The current study aimed to assess the immune profile in patients by setting up immunophenotypes of Treg, effector, and T cells, trying to correlate them with the clinical and biomarker outcomes. The main findings 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 and T-effector cells), and remodelled humoral…

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