The approval also represents the first for AgriLabs' ExactVacTM DNA technology with ENABL^® adjuvant, the first DNA vaccine approved for influenza for veterinary use, and among the first DNA vaccines approved in the United States for food animals.

The vaccine is produced by splicing a gene for a specific antigen related to an Avian Influenza High Pathogenic H5 subtype into a bacterial plasmid. The plasmid is then multiplied, purified and administered along with the ENABL adjuvant that improves vaccine delivery into target cells, where antigens produced by the plasmid elicit an immune response.

Realizing the Promise of DNA Vaccines

The conditional license for high pathogenic H5 will provide a tool for US poultry producers if stockpiling is needed for future avian flu outbreaks. More broadly, this approval represents a significant step in development of an important new technology.

"This is a major milestone in realizing the promise of DNA vaccines in animal health," says Steve Schram, president and CEO of AgriLabs.

"Past DNA research for vaccines for food animals has failed to deliver efficacy, cost and convenience. We believe ENABL adjuvant technology has unlocked the key to DNA vaccines. DNA vaccines offer tremendous potential, and our ENABL technology is unique in its ability to help realize that potential."

According to Mr Schram, DNA vaccines can be tools in the fight against important and emerging animal diseases – via rapid response in vaccine development and production that's far faster than conventional vaccines.

In addition, DNA vaccines are attractive in that they don't expose the animals being treated to disease-producing organisms and there is no risk of a modified pathogen mutating back to a virulent form. DNA vaccines also provide the ability to differentiate among infected and vaccinated animals (DIVA).

ENABL adjuvant technology helps realize that promise through more efficient delivery of DNA-based vaccines, which results in a higher absorption of the DNA vaccine and production of antigen, as well as broader immune response, Schram says.

"ENABL adjuvants feature a patented lipid/polymer matrix that allows for effective dispersion of vaccine micro-particles and more efficient delivery to target cells," Mr Schram says. "In addition to creating a 'micro-depot' effect, this means reduced dosing for DNA vaccines, which makes them economically viable options."

Opportunities for Other Species, Licensing Outside US

The ExactVac DNA technology is applicable to other disease pathogens and animal species, including AgriLabs' next targets of swine influenza and opportunities in cattle production. AgriLabs is seeking partners to license the DNA technology outside the US market for both food and companion animals.

"The ExactVac DNA vaccine with ENABL adjuvant represents the next generation of biological innovation in animal health," Mr Schram says. "AgriLabs is proud to be delivering this DNA-based innovation, which capitalizes on novel adjuvant technology and rapid-response diagnostics, to the market."