SBIR-STTR Award

Swine influenza A Virus (IAV) is a highly contagious respiratory virus that is endemic in pigs worldwide. Swine IAV infections represent an enormous economic loss to producers and can result in acute respiratory disease and severe pathology when acting in concert with other pathogens. Zoonotic transmissions between pigs and humans are a threat to both human health and animal production with spillover events and viral evolution leading to increased diversity. There are three major swine IAV subtypes (H1N1 H1N2 and H3N2) and ~10 distinct Hemagglutinin (HA) genes co-circulating within U.S. swine herds. Repeated outbreaks and rapid spread of genetically and antigenically distinct IAVs represent a considerable challenge for effective swine IAV control. The major problems with current commercially available swine IAV vaccines are 1) the challenge of updating vaccines faster than the rate of viral evolution 2)the time needed for approval and licensing of updated vaccines 3) maternal antibody interference and 4) the lack of an adequate mucosal and cell-mediated immune response. There is an unmet need for closely matched efficacious vaccines that are updated and produced rapidly. The overall goal of this multi-phase SBIR project is to design develop validate and commercialize a system for more-effective swine IAV control that can be utilized by veterinarians and producers. Genvax Technologies' Phase I project is designed to show it is feasible to develop the Genvax Sequence Database and Genvax Prescription self-amplifying RNA (saRNA) Vaccine Platform. Genvax will conduct swine IAV surveillance in production facilities and incorporate the collected sequence data into a centralized repository. The Genvax Sequence Database will be used to create predictive machine-learning (ML) models of viral evolution to improve vaccine design. We will create the first system that allows individual producers to have predictive analytics for viral changes within their farm. Using swine IAV HA sequences from Iowa Farms in 2018 as input we could accurately predict sequences occurring for the following two years (2019-2020). We propose that with more producer-specific data we could train customized ML models for individual production systems or farms and forecast the prevalence and diversity of swine IAV strains up to 12 months into the future. For Objective 2we will attempt to prove the feasibility of the Genvax Prescriptive Vaccine Platform by creating a prescriptive saRNA nanoparticle vaccine that is designed based on producer-specific surveillance data within a 4 week turn-around time. Vaccine efficacy will be demonstrated with an in vivo study in pigs. Genvax has fully completed 5 preliminary swine IAV vaccine efficacy proof-of-concept studies in pigs. Briefly pigs vaccinated with saRNA nanoparticle vaccines with HA as the gene of interest generated protective levels of immunity as demonstrated by high Hemagglutination Inhibition assay titers and protection from viral challenge. The Genvax team has a long history of entrepreneurship and innovative research. Co-investigator Hank Harris founded Harris vaccines which developed innovative RNA particle technology that was a breakthrough in vaccine development. Genvax technology uses a cell-free encapsulation system based on nanoparticle saRNA vaccine delivery. Our goal is to help protect livestock from current and emerging infectious diseases by providing better solutions to veterinarians and producers by commercializing our innovative technologies. The global animal health market is projected to be over $13.6 billion by 2026 with swine vaccines representing $1.8 billion. A successful SBIR project and USDA approval of our vaccine platform will allow Genvax to pursue the $400 million U.S. swine vaccine market that includes targeting swine IAV and other important swine pathogens. The development and commercialization of our prop