INFLUENZA
In April 2005, we received a $0.5 million grant from the NIAID to support the development of a DNA vaccine against influenza. In September 2005, we received a two-year, $2.9 million challenge grant from the NIAID to support the development of a DNA vaccine against naturally emerging or weaponized strains of avian influenza. Funding under the challenge grant will be released in stages contingent upon the achievement of development milestones. In the initial activities covered by the grant, we are collaborating with St. Jude Children's Research Hospital, a world-renowned center of expertise in influenza research, including avian influenza research. During the fourth quarter of 2005, we achieved the first milestone in this challenge grant which was based on the successful design, manufacturing, and initial immunogenicity testing of an avian flu vaccine.
We have shown that our avian flu HA surface protein vaccine is immunogenic in animals. The second milestone under the challenge grant includes challenging DNA-vaccinated animals with a virulent Vietnam strain of H5N1 avian flu. For these studies we are using our proprietary Vaxfectin™ cationic lipid formulation as an adjuvant, as we believe this will significantly enhance the protective immune responses from DNA vaccinations. Our approach is to include vaccine components which we believe will provide potential cross strain protection, particularly against severe disease and mortality, unlike conventional flu vaccines which provide symptomatic relief through antibodies and are unlikely to protect against severe disease and mortality if the strain match is not correct. Our initial influenza vaccine candidates use pDNA encoding two conserved proteins for human flu strains or two conserved proteins for avian flu strains, and one variable surface protein for an avian flu strain.
In March 2006, we presented a poster at the Keystone Symposium, "Advances in Influenza Research: From Birds to Bench to Bedside" showing that an influenza DNA vaccine formulated with the company's patented Vaxfectin™ adjuvant protected mice against lethal challenges with two different strains of human influenza virus.
In May 2006, we announced that our lead three-component influenza flu DNA vaccine candidate provided 100% protection in mice and ferrets against lethal challenges with a highly virulent H5N1 avian influenza virus (Vietnam/1203/2004) in studies conducted by Richard J. Webby, Ph.D., at St. Jude Children's Research Hospital. Additionally, in these and earlier studies in mice, simplified versions of our vaccine candidate using only two of the three components provided high levels of protection against multiple human flu strains and against the H5N1 avian flu strain.
In October 2006, we announced that a single injection of our lead avian influenza DNA vaccine candidate provided 100% protection in ferrets against lethal challenge with the Vietnam/1203/2004 H5N1 virus. Conventional vaccines under development for avian flu typically have required two or more doses in humans, even with novel adjuvants, to produce the immunogenicity levels expected to provide protection.
Also in October 2006, we received approximately $25 million in proceeds from the sale of approximately 5 million shares of our common stock in a registered direct offering to Temasek Holdings (Private) Ltd. of Singapore. All of these shares were sold under a shelf registration statement. Proceeds from the transaction will allow further development of our pandemic influenza DNA vaccine candidate, including funding of Phase 1 human clinical testing.
In August 2007, we enrolled the first subject in a Phase 1 clinical trial of our pandemic influenza vaccine. The double-blind, placebo-controlled trial will evaluate safety, tolerability and immune responses in up to 60 healthy volunteers age 18 to 45 at two U.S. clinical sites.