An international collaboration between Vaxent, a Memphis-based early stage vaccine development company in the Memphis Bioworks Foundation Incubator, and The Pan-Provincial Vaccine Enterprise Inc. (PREVENT), a Centre of Excellence for Commercialization and Research (CECR) in Saskatchewan, has put a vaccine for group A streptococcus (Strep-A) back on the path for potential commercialization. Under the terms of the agreement, PREVENT receives the exclusive worldwide license to progress vaccine candidates through developing vaccine formulations, manufacturing, completing preclinical studies and conducting clinical trials. Both parties will participate in the commercialization process under a cost-sharing and revenue-sharing arrangement.
Group A streptococcus is a significant cause of pharyngitis or "strep throat" in children, as well as other more serious diseases such as streptococcal toxic shock syndrome, necrotizing fasciitis (so-called "flesh-eating disease") and acute rheumatic fever and rheumatic heart disease. There are 11 million physician office visits for sore throat or suspected strep throat in the U.S. each year, with 15 to 30 percent of those cases confirmed positive for group A streptococcus. The total cost (direct health care and indirect productivity loss) of these infections is estimated to be $2 billion annually in the U.S., alone.
The Strep-A vaccine was developed over 25 years of laboratory research by James B. Dale, MD, Gene H. Stollerman Professor of Medicine and Chief of the Division of Infectious Diseases at the University of Tennessee Health Science Center in Memphis, Tennessee. Dr. Dale is the Chief Scientific Officer for Vaxent. Since April, 2008 Vaxent has been a part of the Memphis Bioworks Incubator.
"The 30-valent vaccine for Strep-A is the most complex genetically engineered vaccine ever developed for clinical trials," said Dale. "It will cover between 90 and 95 percent of Strep-A found in North America and could have a significant impact on the incidence of strep throat and more serious, invasive infections. In addition, an effective Strep-A vaccine could lead to a significant decrease in the need for antibiotic administration in children, thus reducing the risk of antibiotic resistance of other bacteria."
"Vaxent is an excellent example of local science and technology moving from the research laboratory to local entrepreneurial incubation and now on to the next step toward the marketplace," said Dr. Steve Bares, president and executive director of the Memphis Bioworks Foundation. "Our ability as a community to successfully nurture our local science will have long term benefits for our community, and in this case for world health."
Over a three year period, it is expected that the agreement will progress through manufacture of the vaccine, to pre-clinical testing, to a phase 1 clinical trial in adult volunteers. Only after success at this stage will an age step-down study be launched to test the vaccine in adolescents and children.