TxCell to receive US patent for Ovasave to treat inflammatory bowel disease

Patent ensures protection for Ovasave(R) in the US until 2030 minimum

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.