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news.Vical has been advised that, following a US National Institutes of Health review of preclinical data on the company's avian flu vaccine, it qualifies for accelerated access to $2.6 million in funding for further vaccine development.
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The funds will be used to complete preclinical development of the vaccine and file an investigational new drug application (IND) with the FDA, which would allow initiation of a phase I safety trial in human volunteers. The company is seeking additional funding to support phase I human testing.
The preclinical data showed Vical's Vaxfectin-formulated, three-component DNA vaccine provided complete 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.
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.
Vical is collaborating on this program with St Jude Children's Research Hospital in Tennessee, US. The goal is to design a vaccine that could be developed and manufactured quickly and safely, without handling the infectious organism, and stockpiled longer than conventional vaccines.
The vaccine is expected to target both variable surface proteins and unchanging core proteins of the virus for protection against potential pandemic outbreaks characterized by highly virulent pathogens, rapid human-to-human disease transmission, and minimal prior immunity.