Immune Targeting Systems (ITS), a U.K. company specializing in the development of novel T cell immune therapies, has developed a new T cell vaccine (Flunisyn) designed to protect humans from all strains of seasonal and pandemic influenza A. ITS has sold the strain to California-based CRO WCCT Global for further development.
To determine the effectiveness of Flunisyn, ITS produced its own live influenza challenge agent derived from the recently circulating Influenza A/California/2009 (H1N1) virus. This challenge virus, manufactured in compliance with FDA and other regulatory agency requirements, has a much better infectivity profile than reported for similar challenge viruses. While the main purpose in developing its own challenge virus was to advance the development of Flunisyn and to further understand the natural course of influenza illness, ITS wants to make the virus available to enable and support the development of new antiviral drugs and vaccines.
Immune Targeting Systems has inked an asset purchase agreement with WCCT Global (WCCTG) for ITS' proprietary developed challenge strain. WCCTG now offers sponsors the ability to do large-scale influenza challenge studies in the U.S. The Experimental Human Viral Challenge Model has become widely accepted as an alternative to traditional early stage field trials to show the efficacy of antiviral and vaccine therapies.
The WCCTG facility in Costa Mesa, Calif., has been completely reconfigured to provide private rooms, separate ventilation and other standard containment provisions to accommodate this research model and ensure the safety and comfort of the volunteers and staff.