One of just 13 companies invited to present information at the forum, VaxLiant showed how its novel adjuvant, ENABLTM, can be combined with gene-sequenced DNA to create a stable delivery format for commercial vaccines — something that has not been possible until now. The Aug. 12 publication of the US Department of Agriculture (USDA) Center for Veterinary Biologics’ (CVB’s) guidelines for licensing production platforms using recombinant DNA makes bringing to market an affordable ENABL vaccine that can combat this highly contagious viral disease possible within the next three years.

"The new CVB guidelines identify the steps to take to receive approval of a ‘production platform’ — the process of consistently, safely manufacturing vaccines using recombinant DNA technology," said Steve Schram, co-founder of VaxLiant. "This means there is now a pathway for our ENABL vaccine platform to become USDA-licensed — which can lead to vaccines for AI and other emerging diseases that are more practical and affordable than today’s options, in about one-third of the time. That’s why we were at the Investment Forum, inviting companies to consider an exclusive strategic partnership to develop a truly innovative AI vaccine."

As reported AI cases continue to climb throughout the world and the AI virus evolves, having access to a USDA-approved production platform that enables safe, more rapid vaccine development is an important breakthrough.

"We believe we’re the only company to have developed a DNA platform that works and is practical for broad application to animal health, and it’s because we have an adjuvant that allows it to work," said Timothy Miller, PhD, VaxLiant co-founder. "Research shows that ENABL allows the DNA component of an AI vaccine to remain intact and stable. And, it provides higher levels of effectiveness against the AI virus using about 70 percent less antigen, finally making production of an affordable vaccine possible to benefit poultry farmers everywhere."

According to Dr Miller, a production platform using DNA technology is a breakthrough that can be used to fight not only AI, but also other devastating transboundary diseases, including foot-and-mouth disease and African swine fever.

"Producing vaccines using the ENABL platform does not use live-virus or animal-origin material, which means manufacturers can produce vaccines to combat these highly contagious diseases safely," said Dr Miller. "This also means vaccinated birds and animals can be distinguished from non-vaccinates that are harboring the actual virus, so countries could finally allow the import and export of livestock and poultry given vaccines that include ENABL."

In publishing its new guidelines for vaccine platforms, the CVB cited the importance of having an approach that allows governments and other organizations to respond more quickly to emerging diseases created by antigenic shift — the process of two or more strains of a virus, or different viruses, combining to form a new viral strain.

"Throughout history, viruses have evolved to survive," said Mr Schram. "Using traditional vaccine technologies, it has been difficult to develop vaccines to fight disease caused by emerging viruses in a timely fashion. Once the ENABL platform has been reviewed and approved by USDA, companies will have the flexibility they need for a quicker vaccine-development timeline — an exciting prospect for veterinarians and farmers who care deeply about the health and well-being of their animals."

ENABL is already available in 15 ready-to-use formulations for use in both traditional and new vaccines for cattle, pigs and poultry. ENABL adjuvants provide never-seen-before flexibility and benefits, including in vitro screening, effectiveness using less antigen, improved stabilization, ease of recovering antigen for product-release assaid, and the ability to stimulate different immune responses using a variety of formulations, ranging from traditional killed and modified-live virus vaccines to those using DNA and gene-vector technology.