PolTREG
PolTREG is a clinical-stage company focused on cell-therapy of autoimmune diseases. We are developing T regulatory cell-based products including: – polyclonal Tregs, – CAR-Tregs, – TCR-Tregs and – antigen-specific oligoclonal Tregs. Currently, clinical stage products are autologous but we also work on allogeneic setting. All the products are manufactured in our facility in Gdańsk. The production capability is around 1500 cellular products per year. Up to now, we have completed four clinical trials in type 1 diabetes and multiple sclerosis. Over 100 patients were treated with our Tregs with good efficacy and safety profiles. The longest follow up of our patients is over 10 years now. We are looking for partnering model of collaboration in order to go into marketing authorisation with our products. We are ready for pivotal trial in type 1 diabetes and phase I/II in multiple sclerosis. There is also preclinical work with auto- and allogeneic Tregs to be developed into the clinic. References to our work: 1. Trzonkowski P et al. First-in-man clinical results of the treatment of patients with graft versus host disease with human ex vivo expanded CD4+CD25+CD127- T regulatory cells. Clin Immunol. 2009;133(1):22-6. 2. Marek-Trzonkowska N et al. Administration of CD4+CD25highCD127- Regulatory T Cells Preserves β-Cell Function in Type 1 Diabetes in Children. Diabetes Care. 2012, 35(9):1817-20 3. Marek-Trzonkowska N et al. Therapy of type 1 diabetes with CD4+CD25high CD127-regulatory T cells prolongs survival of pancreatic islets – Results of one year follow-up. Clinical Immunology. 2014; 153:23-30. 4. Marek-Trzonkowska N et al. Factors affecting long-term efficacy of T regulatory cell-based therapy in type 1 diabetes. J Transl Med. 2016 Dec 1;14(1):332. 5. Zieliński M et al. Combined therapy with CD4+ CD25highCD127- T regulatory cells and anti-CD20 antibody in recent-onset type 1 diabetes is superior to monotherapy: Randomized phase I/II trial. Diabetes Obes Metab. 2022 Aug;24(8):1534-1543. 6. Chwojnicki K et al. Administration of CD4+CD25highCD127-FoxP3+ Regulatory T Cells for Relapsing-Remitting Multiple Sclerosis: A Phase 1 Study. BioDrugs. 2021 Jan;35(1):47-60. 7. Trzonkowski P et al. Hurdles in therapy with regulatory T cells. Science Transl Med. 2015; 7(304):304ps18 8. Piekarska K et al. Mesenchymal stem cells transfer mitochondria to allogeneic Tregs in an HLA-dependent manner improving their immunosuppressive activity. Nat Commun. 2022 Feb 14;13(1):856.
