- New biomarker might facilitate monitoring T1D sufferers’ well being
- Enhance in PD-1+ T-cells correlated with therapeutic response and fewer insulin use
GdaÅ„sk, Poland “ 4 April 2024 “ PolTREG S.A. (Warsaw Inventory Trade: PTG) , a clinical-stage biotechnology firm growing mobile therapies for a variety of autoimmune ailments, in the present day declares it has printed knowledge in Worldwide Immunopharmacology which recommend that PD-1+ T-cells are a reliable biomarker for efficacy in pediatric early-onset Kind-1 diabetes (T1D) sufferers, who had been efficiently handled with PTG-007 Treg cell remedy, the corporate’s lead asset. The brand new outcomes are from a two yr immune-monitoring knowledge follow-up of 36 sufferers who had participated in a randomized, placebo-controlled Section 1/2 scientific trial. This three-arm trial had earlier proven that fifty% of PTG-007-treated sufferers together with rituximab had been nonetheless in remission after 24 months.
PolTREG CEO Piotr Trzonkowski, who co-authored the peer-reviewed research, mentioned: This peer-reviewed scientific publication provides to our rising pleasure in regards to the potential of polyclonal Treg therapies. Now we have handled over 100 sufferers with our cell remedy at our facility over the past 17 years. This has afforded us a wealth of information and unrivalled expertise with how T1D and different autoimmune ailments reply to varied therapies, together with our polyclonal Treg cell therapies and – beginning subsequent yr – engineered Treg therapeutics. Having a biomarker of efficacy, like PD-1+ T-cells, may facilitate medical doctors’ capacity to observe their sufferers’ responses to remedy. We already use this knowledge to construct new cell merchandise and design subsequent trials in direction of advertising authorisation. It exhibits the power of our distinctive method of utilizing the expertise from working with sufferers as the idea to construct our portfolio.
The primary discovering of the Section 1/2 research, outcomes of which had been printed in 2022, was that mixed therapy with autologous T-regulatory cells (Treg) and rituximab is superior to monotherapy in T1D. The present research aimed to evaluate the immune profile in sufferers by establishing immunophenotypes of Treg, effector, and T cells, making an attempt to correlate them with the scientific and biomarker outcomes. The primary findings had been the next:
- A scientific response in T1D to therapy with polyclonal Treg cells and rituximab is related to elevated percentages of PD-1+ T-cells (each T-reg and T-effector cells), and remodelled humoral immunity
- Elevated ranges of PD-1+ T-cells correlated with profitable therapy and must be confirmed by additional research as a biomarker of efficacy
- Greater expression of PD-1 receptor on T-cells additionally correlated with a greater response in sufferers, resembling needing a decrease every day dose of insulin.
- Monitoring PD-1+ T-cells might allow immune monitoring of the remedy
PolTREG holds one of the superior pipelines for Treg therapies for autoimmune illness, growing each polyclonal and engineered cells. Its lead candidate, PTG-007, an autologous polyclonal Treg therapy, is in mid-stage scientific research for T1D and a number of sclerosis (MS). Subsequent yr, PolTREG expects to start out a first-in-human trial of its engineered CAR-Tregs for therapy of two neurodegenerative ailments – MS and amyotrophic lateral sclerosis (ALS). The corporate is also in preclinical improvement with two additional varieties of engineered Treg cells.
PolTREG manufactures all its Treg therapeutics at its wholly-owned GMP-certified manufacturing facility. It’s the first firm on this planet to manage T-reg therapies to sufferers, and, beneath a hospital exemption legitimate in Poland, the primary to start out receiving revenues from a Treg therapeutic for autoimmune illness. Its GMP manufacturing facility is certainly one of Europe’s largest and most superior, boasting over 2,100 sqm of laboratory house, together with 15 manufacturing traces. PolTREG has the choice to considerably broaden the ability to accommodate manufacturing of next-generation engineered therapies and cell therapies from future companions.
About PolTREGPolTREG is a world chief in growing autoimmune therapies primarily based on T-regulatory cells (Tregs). Its lead product, PTG-007, autologous Treg therapy for early-onset Kind-1 Diabetes (T1D) is prepared for Section 2/3 scientific testing, for which the corporate is searching for a partnership. The corporate will launch Section 2 trials for PTG-007 to deal with A number of Sclerosis (MS) within the second half of 2024, for RRMS and PPMS. PolTREG additionally has engineered Tregs, together with CAR-Tregs, antigen-specific Tregs and TCR-Tregs, within the preclinical stage. PolTREG has accomplished 4 scientific trials with greater than 100 sufferers handled with Tregs.
For extra data please go to www.poltreg.com.
For additional data please contact:PolTREG S.A.Prof Piotr TrzonkowskiChief Govt Officer[email protected]+48 512 532 401 | Investor RelationsChris MaggosCohesion Bureau+41 79 367 62 [email protected]Media Relations Douwe MiedemaCohesion Bureau+352 621 562 [email protected] |
Essential dataThe contents of this announcement embrace statements which might be, or could also be deemed to be, “forward-looking statements”. These forward-looking statements could be recognized by way of forward-looking terminology, together with the phrases “believes”, “estimates,” “anticipates”, “expects”, “intends”, “might”, “will”, “plans”, “proceed”, “ongoing”, “potential”, “predict”, “challenge”, “goal”, “search” or “ought to”, and embrace statements the Firm makes regarding the supposed outcomes of its technique. By their nature, forward-looking statements contain dangers and uncertainties and readers are cautioned that any such forward-looking statements will not be ensures of future efficiency. The corporate’s precise outcomes might differ materially from these predicted by the forward-looking statements. The corporate undertakes no obligation to publicly replace or revise forward-looking statements, besides as could also be required by legislation.
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Supply: PolTREG S.A.