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AgriLabs helps realize potential of DNA vaccines with milestone avian flu approval

The USDA has handed its first conditional approval to a DNA vaccine for chickens.

The authorization was for St Joseph, Missouri-based business AgriLabs. Not only is this a landmark for the USDA but it is also the first time an approval has been given to AgriLabs' ExactVacTM DNA technology with ENABL adjuvant.

Additionally, this is the first DNA veterinary vaccine approved for influenza and among the first DNA vaccines authorized in the US for food-producing animals.

Steve Schram, president and chief executive of AgriLabs, said: "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.

"The ExactVac DNA vaccine with ENABL adjuvant represents the next generation of biological innovation in animal health."

DNA vaccines offer a much more rapid response to emerging diseases compared to conventional vaccines.

Not only do DNA vaccines have a shorter development timeline, they do not expose animals to disease-producing organisms. This means there is no risk of a modified pathogen mutating back into a virulent form. DNA vaccines also provide the ability to differentiate among infected and vaccinated animals.

AgriLabs said its ENABL adjuvant technology helps realize the promise of DNA vaccines 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".

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

DNA vaccines are gaining more of a foothold in animal health. Earlier this year, Elanco secured the first approval of a DNA vaccine for veterinary use in Europe.

Gene splicing technique

The AgriLabs 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," AgriLabs said.

This conditional approval will add to the country's protective measures against avian flu if stockpiling is needed to combat any future avian flu outbreaks.

In recent years, Zoetis, Ceva Santé Animale and Harrisvaccines had avian flu vaccines added to the national stockpile.

Swine influenza and cattle diseases next

The firm's ExactVac DNA technology is applicable to other disease pathogens and animal species. AgriLabs is also targeting vaccines against swine influenza and certain cattle diseases.

The company is also looking for partners to license the DNA technology outside the US market for both food animals and pets.

Last year, AgriLabs made several significant acquisitions in a bid to become a fully integrated concept-to-commercialization business for food animal vaccines. The commercialization of the DNA vaccine platform is a result of this move.



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