Abstract
Among the most innovative immunotherapies, autologous cellular immunotherapy aims at treating patients with their own immune cells that, before reinjection, have been educated ex vivo to fight disease. Antigen-specific regulatory T cells (Ag-Treg) are recognized as a promising tool for therapeutic intervention in patients with chronic inflammation and autoimmunity. Ovasave ® is an autologous ovalbumin-specific Treg (Ova-Treg) product that is in development for the treatment of severe Crohn's disease patients refractory to available treatments. Ovasave ® has shown a good tolerability and dose-related efficacy in a first-in-man open-labeled phase I/IIa study in refractory Crohn's disease patients. In this study, a 75% response rate and a 38% remission rate on the CDAI (Crohn's Disease Activity Index) were observed at the best dose. In addition, clinical response was correlated with a decrease in vitro proliferation of patient's white blood cells in response to ovalbumin, indicating that decreased proliferation to Ag-Treg specific antigen could be used as a biomarker of clinical response. A randomized controlled phase IIb clinical study with Ovasave will start mid-2014 to confirm the efficacy and tolerability of Ovasave ® in refractory's Crohn's disease patients. Ag-Treg manufacturing has been developed to be highly cost-effective and logistically simple: multiple years of treatment doses are manufactured by one processing from one blood sample. Ovasave ® is the lead product from TxCell's ASTrIA platform Ag-Treg products. From this platform, Col-Treg, an autologous collagen-II specific based product is in the final preclinical stage of development for the treatment of patients with autoimmune uveitis, an orphan chronic inflammatory condition of the eye, with a phase I/IIa clinical study planned for 2015. With Ovasave ® and Col-Treg as novel, personalized cellular immunotherapies for chronic autoimmune inflammatory diseases, Ag-Tregs represent a new therapeutic opportunity for patients who today have few or no treatment options.
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