Oral and poster presentations to include details of manufacturing process development for TxCell lead product Ovasave(R) as well as positive results for second product Col-Treg
Valbonne, France, May 28, 2015 – TxCell SA (FR0010127662 – TXCL), a biotechnology company developing innovative, personalized T cell immunotherapies using antigen specific regulatory T-cells (Ag-Tregs) for severe chronic inflammatory and autoimmune diseases, announces today that Dr. Arnaud Foussat, VP Research and New Products, TxCell, will deliver two presentations at the 21st Annual Meeting of the International Society of Cellular Therapy, May 27-30, 2015, in Las Vegas, Nevada, US.
The first (oral) presentation concerns Col-Treg, TxCell’s second product candidate. The presentation will be entitled ‘Immunotherapy of Non-Infectious Uveitis using antigen-specific regulatory T (Treg) cells’. Col-Treg is in development to target autoimmune (non-infectious) uveitis, a rare eye disease that can lead to blindness. Col-Treg is now set to start a first clinical trial in 2016. Col-Treg received an orphan drug designation from the EU in December 2014. The presentation will take place on Thursday May 28 - Session 2 Immunotherapy and Dendritic cells, 11.15am – 12.30pm, Florentine Ballroom III/IV. The presentation will provide detail of preclinical efficacy and tolerability results with Col-Treg in the treatment of autoimmune uveitis. These results include pharmacodynamic and pharmacokinetic 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.
The second (poster) presentation is entitled ‘Comparability study during manufacturing process development of Ovasave, an Ovalbumin-specific Type 1 Treg immuno-cellular therapy of refractory Crohn’s Disease’. Ovasave(R) is TxCell’s lead product candidate in development to target refractory Crohn’s disease. A multinational placebo-controlled phase IIb clinical study is ongoing with top line results expected in 2017. The presentation will take place at Poster Session 1: Thursday, May 28: 5.30pm – 7.00pm. The presentation provides details of comparability studies between Ovasave manufacturing process and products, for the phase I/II (CATS1) and phase IIb (CATS29) clinical studies.
“There is a growing body of scientific evidence that T regulatory cells could play as big a role in autoimmunity and chronic inflammation as T effector cells in oncology. This is illustrated by the level of attention TxCell programs are getting at ISCT this year,” said Stéphane Boissel, CEO of TxCell. “The current dynamics in the cellular immunotherapy space as well as events such as ISCT provide additional encouragement for us to accelerate our development, both individually and with partners, for particular target markets. In this context, business partnerships should be important strategic considerations.”
About ISCT
ISCT is a global association driving the translation of scientific research to deliver innovative cellular therapies to patients. ISCT is the only group focused on pre-clinical and translational aspects of developing cell therapy products. As such, ISCT helps academic, government and biotech/pharma sectors transform research into practice and product.
About TxCell
TxCell develops innovative, personalized T cell immunotherapies for the treatment of severe chronic inflammatory diseases with high medical need. TxCell has created ASTrIA, a unique and proprietary product platform based on the properties of autologous antigen-specific regulatory T lymphocytes (Ag-Tregs). The company has initiated a phase IIb study of its lead product candidate, Ovasave(R) in refractory Crohn’s disease patients. This follows a phase I/IIa study in the same patient population reporting positive clinical efficacy and good tolerability. TxCell has a strategic partnership for the development of Ovasave with the Swiss company Trizell Holding SA and Ferring International Center remains the intended final commercializing party. Both companies are affiliates of the Dr Frederik Paulsen Foundation. TxCell’s second product candidate, Col-Treg is for the treatment of autoimmune uveitis, a rare disease of the eye. Listed on the regulated market Euronext Paris, TxCell is a spin-off of Inserm (France’s National Institute for Health and Medical Research). TxCell has 68 employees based both at the headquarters located in the Sophia Antipolis technology park, Nice, France and at its manufacturing site in Besançon. For further information visit www.txcell.com
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