Immune Targeting Systems (ITS), specializing in the development of novel T cell immune therapies, has been developing an exciting new T cell vaccine (Flunisyn) designed to protect humans from all strains of seasonal and pandemic influenza A.
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 the high level of quality and characterization required by the US FDA and other regulatory agencies, has a much better infectivity profile than reported for similar challenge viruses.
Whilst 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 announced an asset purchase agreement with WCCT Global (WCCTG) for ITS' proprietary developed challenge strain. Through this partnership, WCCTG has become the only commercial company offering sponsors the ability to do large scale influenza challenge studies in the United States. 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, California, has been completely reconfigured to provide private rooms, separate ventilation and other standard containment provisions to accommodate this valuable research model and ensure the safety and comfort of the volunteers and staff.
Benjamin Chen, PhD, CEO of Immune Targeting Systems said, "We are very excited that WCCT Global has taken over the ownership of this important clinical research tool and are confident that they will use the virus to help support the development of new vaccines and antiviral drugs". Kenneth Kim, MD, CEO of WCCT Global said, " The capability to carry out the experimental influenza challenge model in conjunction with our deep-seated expertise in anti-viral drug development will surely be of great interest to our sponsors. This new capability combined with our Full Service Global capabilities, specialized influenza project teams, and deep scientific knowledge allows WCCTG to manage vaccine and antiviral development programs from First in Man through NDA submission."
Immune targeting Systems, Ltd develops T-cell vaccines to highly mutated viruses and to cancers. The company's lead product Flunisyn vaccine has been shown in three clinical studies to stimulate the production of T-cells that recognise and destroy influenza-infected cells. Flunisyn is a pan-influenza A vaccine applicable to multiple influenza strains without the need to be re-manufactured for each influenza season or pandemic outbreak.
WCCT Global is a multi-site, full service pharmaceutical contract research organization (CRO) of outsourced early drug development and late phase services to the pharmaceutical, biotechnology and medical device industries.. As a drug development partner, WCCT Global collaborates with domestic and foreign innovator companies who need regulatory, program management, data management, patient recruitment services, and strategic consulting support, with an emphasis on overseeing and executing trials in special disease populations, pediatric populations, ethno-bridging, influenza, and cardiac safety.