Vical's avian flu vaccine meets NIH funding criteria
resulted in the company coming one step closer to $2.6m (€2m) in
funding for further development of the vaccine under a grant
awarded by the US government.
The results of the trial is in response to a surging demand for a widely available flu vaccine that is cheap to manufacture as worldwide governments prepare for a potential bird flu pandemic.
According to the World Health Organisation, approximately 200 people have caught the disease and 113 have died worldwide since its onset in Asia in 2003.
The National Institutes of Health (NIH), an agency of the US Department of Health and Human Services were given data demonstrating Vaxfectin-formulated, three-component DNA vaccine provided 100 per cent protection of mice and ferrets against lethal challenges with the H5N1 avian influenza virus as well as protection of mice against multiple human flu strains.
Vaxfectin is a second-generation, cationic lipid-based adjuvant optimised by Vical to increase the immune response in DNA vaccines.
Adjuvants are useful generally for improving the immune response of an organism to a particular immunogen and are commonly included in vaccine compositions to increase the amount of antibodies produced and/or to reduce the quantity of immunogen and the frequency of administration.
The funds will be used to complete preclinical development of the vaccine and file an Investigational New Drug Application (IND) with the US Food and Drug Administration (FDA).
This would allow initiation of a Phase I safety trial in human volunteers.
"One significant strength of our DNA technology is the speed with which we can develop a vaccine product concept, establish preclinical efficacy, and then advance to IND filing," said David Kaslow, Vical's Chief Scientific Officer.
"Our Vaxfectin-formulated DNA flu vaccines have performed well in animal challenge studies, and this accelerated access to funding allows us to move forward ahead of our original schedule, which is quite important given the imminent threat posed by pandemic influenza."
Vical, who are collaborating on this program with St. Jude Children's Research aim to design a vaccine that could be developed and manufactured quickly and safely, without handling the infectious organism, and stockpiled longer than conventional vaccines.
If stockpiling issues can be overcome, the vaccine appears to be an answer to the logistics and storage problems that are associated with such a therapy.
In the wake of the avian flu scare, the rush by governments worldwide to stockpile enough vaccines has often overtaken thoughts on how the vaccine is best handled under its optimal conditions.
Vical's vaccine is expected to target both variable surface proteins and unchanging core proteins of the virus for protection against potential pandemic outbreaks characterised by highly virulent pathogens, rapid human-to-human disease transmission, and minimal prior immunity.
Remaining preclinical work includes safety, toxicology and biodistribution testing of the formulated vaccine in laboratory animals, as well as manufacturing of human clinical trial supplies in compliance with current Good Manufacturing Practice (GMP).
