Phase I/II Clinical Study Planned for Col-Treg
TxCell set for phase I/II proof of principle clinical study in Q2 2015 for its second therapeutic candidate in this rare eye disease
TxCell SA (FR0010127662 – TXCL), 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, a leading cause of blindness with very limited treatment options.
Efficacy and Tolerability Demonstrated in Preclinical Model
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 manufacturing technicians performing antigen-specific Treg cells …
“The new data obtained with Col-Treg have provided further confirmation of the potential of Col-Treg, TxCell’s second product candidate from its ASTrIA platform, as a much-needed new treatment for autoimmune uveitis,” said Arnaud Foussat, VP Research and New Products at TxCell. ”After strong phase I/IIa results in Crohn’s disease with Ovasave(R), these results with Col-Treg confirm the versatility and robustness of our innovative proprietary technological platform, ASTrIA, of personalized T cell immunotherapies for severe chronic inflammatory and autoimmune diseases.”
Understanding Autoimmune Uveitis and Treg Cells
Autoimmune uveitis has been characterised as a disease in which there is a dysfunction of the T regulatory cell compartment of the immune system. Recent scientific studies have demonstrated that the administration or induction of regulatory T (Treg) cells in vivo can be used as therapeutic tools for the control of ocular inflammation, including that seen in autoimmune uveitis. As a result, TxCell is developing Col-Treg as a personalized T cell immunotherapy based on the regulatory properties of autologous collagen-II specific regulatory T lymphocytes. Col-Treg is specifically designed to exert a multi-target, multi-mechanism suppressive and anti-inflammatory action locally in the eye upon recognition of collagen-II, a protein present in the vitreous body of both the eye and retina.
Robust Manufacturing Process for Col-Treg
TxCell has ensured that Col-Treg will benefit from a robust manufacturing process, utilising its experience with Ovasave(R), TxCell’s lead product for inflammatory bowel diseases. Manufacturing of Col-Treg will takes place in TxCell’s own GMP accredited French manufacturing facility.
Next Steps: Regulatory Strategy and Development
“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.”
“This successful demonstration of the therapeutic potential of Col-Treg is another important milestone for TxCell,” said Damian Marron, CEO TxCell. “This achievement is central to TxCell’s strategy of targeting orphan/niche indications with poor or no treatment options. We will run the proof of principle clinical study with Col-Treg along with developing the other products in our portfolio, including TxCell’s lead product Ovasave for inflammatory bowel diseases, which is approaching the start of a phase IIb study in refractory Crohn’s disease and is partnered with Ferring International Center.”
