Patent ensures protection for Ovasave(R) in the US until 2030 minimum
Valbonne, France, March 18, 2015. – TxCell SA, a biotechnology company developing innovative, cost-effective, personalized T cell immunotherapies using antigen specific regulatory T-cells (Ag-Tregs) for severe chronic inflammatory and autoimmune diseases, today announces that a key patent is to be granted on March 31 2015 by the United States Patent and Trademark Office (USPTO). The issue notification has been posted on the USPTO portal (http://portal.uspto.gov). The patent covers its lead product Ovasave(R) in inflammatory bowel disease (IBD). Ovasave is currently being studied in a multinational placebo-controlled phase IIb study in refractory Crohn’s disease.
The US patent, number 8992907, will run until October 2030 (not including supplementary protection certificate (SPC)). The patent is the latest strong asset for TxCell. It widely protects a highly promising method for treating intestinal inflammatory bowel diseases with its lead personalized T cell immunotherapy candidate, Ovasave (ovalbumin-specific autologous Treg cells (Ova-Treg)). Specifically, the patent covers the administration of a composition consisting of at least one human Type 1 Treg cell population directed against a food antigen from common human diet. The equivalent patent has already been granted in Russia. Other corresponding patent applications for Ovasave in IBD are pending in major markets globally. TxCell now owns or controls more than 140 patents within its patent portfolio in the field of antigen-specific Treg (Ag-Treg) cell-based therapy. These provide extensive coverage of the characterisation, production and use of Ag-Tregs for the treatment of chronic autoimmune inflammatory diseases.
“This valuable new US patent further bolsters TxCell’s intellectual property coverage and provides extensive coverage for TxCell’s lead product Ovasave in the world’s largest market. Combined with other globally granted and pending patents for TxCell’s product portfolio, TxCell is building a critical comprehensive and enforceable patent portfolio to protect the commercial potential of our personalized T cell immunotherapies,” said Damian Marron, Chief Executive Officer of TxCell. “TxCell now owns or controls a total of more than 140 granted patents in the field of antigen-specific Treg cell-based therapy. We will continue to actively protect our new discoveries to further protect and extend our innovative technologies and product portfolio.”
TxCell granted Ferring SA an exclusive option to license the Ovasave intellectual property portfolio for the treatment of IBD, following the completion of the ongoing phase IIb trial in refractory Crohn’s disease. The original agreement was signed by TxCell and Ferring in December 2013 and is potentially worth up to EUR 76 million plus royalties subject to the achievement of milestones. The agreement was then extended with an assignment to a fellow affiliate of Ferring, Trizell SA, to add specialist management and scientific and development expertise. Ferring will remain the intended commercialisation partner.
The next milestone in the Ovasave program will be the US regulatory update expected mid-2015. In addition, the first interim report of the independent Data and Safety Monitoring Board on the ongoing phase IIb study is expected in the fourth quarter of this year.
About TxCell
TxCell develops innovative, cost-effective, personalized T cell immunotherapies for the treatment of severe chronic inflammatory diseases with high medical need. TxCell has created ASTrIA, a unique and proprietary technology 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. A placebo-controlled, dose-ranging proof of principle clinical study is planned to start in the first half of 2015. Listed on Euronext-Paris, TxCell, a spin-off of Inserm (France’s National Institute for Health and Medical Research) is located in the Sophia Antipolis technology park, Nice, France. The company has 63 employees based at its headquarters and at its manufacturing site in Besançon. For more information, please visit www.txcell.com
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