Clinical Trials

cell therapy/immunotherapy product. Col-Treg is a personalized cell-based immunotherapy product, based on the properties of autologous collagen II-specific regulatory T lymphocytes. It is specifically designed to exert its suppressive and anti-inflammatory action upon recognition of collagen-II, a protein present in the vitreous body of the eye. Col-Treg has shown efficacy and safety in several different autoimmune disease models and has shown no toxicity in a toxicology study performed under Good Laboratory Practice (GLP). Col-Treg uses the natural properties of the patient’s own Type 1 Treg cells, which home preferentially to the sites of injury and control inflammation by multiple pathways:  secreting natural immunosuppressive molecules; initiating cell-cell contact mediated suppression through surface molecules and killing of myeloid cells. These multiple mechanisms of action lead to inhibition of pro-inflammatory cell activation, proliferation and cytokine production.

Col-Treg is TxCell’s second therapeutic candidate from its ASTrIA platform after Ovasave®. The product received orphan drug designation from the EU in December 2014.

 

* On May 5, 2015, TxCell SA, a biotechnology company developing innovative, personalized T-cell immunotherapies using antigen
specific regulatory T-cells (Ag-Tregs) for severe chronic inflammatory and autoimmune diseases, announced that activity and tolerance data for its second lead product ColTreg were presented through a poster presentation at the 2015 ARVO Annual Meeting, May 3-7, 2015, in Denver, Colorado, US. The presentation was delivered by Dr. Hélène Asnagli, Preclinical Pharmacology & Safety Director, in the session entitled ‘AMD immunobiology, autoimmunity, and immunoregulation’. The poster entitled ‘Immunotherapy of Non-Infectious Uveitis using Collagen II-specific regulatory Type 1 (Col-Treg) cells’ presented preclinical efficacy and tolerability results with Col-Treg in the treatment of autoimmune uveitis. These results include pharmacokinetic and pharmacodynamic data showing a reduction in the severity of uveitis on clinical and histologic measures. In addition, TxCell has also generated GLP toxicology results that indicate a good safety profile for Col-Treg. Col-Treg is set to start a phase I/II placebo-controlled, dose-ranging proof of principle clinical study in autoimmune uveitis mid-2015. 
* On October 28, 2014, TxCell, a biotechnology company developing innovative, economically viable, personalized T cell immunotherapies using antigen specific regulatory T-cells (Ag-Tregs) for severe chronic inflammatory and autoimmune diseases, announced that TxCell researchers have achieved positive results for Col-Treg, its second product candidate from its ASTrIA platform, in a model of autoimmune uveitis. TxCell demonstrated clear efficacy and tolerability of Col-Treg for the treatment of autoimmune uveitis. The results generated in the model include pharmacodynamic and pharmacokinetic data that shows a reduction in the severity of uveitis on clinical and histologic measures. In addition, TxCell has also generated GLP toxicology results that indicate a good safety profile for Col-Treg. TxCell intends to submit these results for publication in a recognized, peer-reviewed journal. TxCell has ensured that Col-Treg will benefit from a robust manufacturing process, utilising its experience with Ovasave®, TxCell’s lead product for inflammatory bowel diseases. Manufacturing of Col-Treg will takes place in TxCell’s own GMP accredited French manufacturing facility. “TxCell intends to advance rapidly with the development of Col-Treg. We will be looking to obtain orphan drug designations in the European Union and in the United States. Following that, we intend to launch a placebo-controlled proof of principle clinical study for the treatment of patients with autoimmune uveitis that are refractory to approved treatments,” said Miguel Forte, Sr. VP Clinical Development and Regulatory Affairs of TxCell. “TxCell plans to start this study in Q2 2015. The trial will be undertaken in a number of specialist ophthalmology centres in Europe.”

* On January 7, 2014, TxCell has announced it has initiated a full development program with Col-Treg for the treatment of a rare serious inflammatory disease, autoimmune uveitis. The current first-line treatment consists of corticosteroids, often used with antimetabolites and alkylating agents. However, there are currently no approved options for the 50% of patients that become refractory to steroid compounds. The development of Col-Treg for treatment of steroid refractory patients could bring a new therapeutic possibility for these patients.