GENVAX TECHNOLOGIES INC — Department of Agriculture SBIR Phase I: 8.3

Description

Project Summary/AbstractSwine influenza A Virus (IAV) is a highly contagious respiratory virus that is endemic in pigsworldwide. Swine IAV infections represent an enormous economic loss to producers and canresult in acute respiratory disease and severe pathology when acting in concert with otherpathogens. Zoonotic transmissions between pigs and humans are a threat to both human healthand 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 distinctHemagglutinin (HA) genes co-circulating within U.S. swine herds. Repeated outbreaks and rapidspread of genetically and antigenically distinct IAVs represent a considerable challenge foreffective swine IAV control. The major problems with current commercially available swineIAV 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 antibodyinterference and 4) the lack of an adequate mucosal and cell-mediated immune response. Thereis 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 andcommercialize a system for more-effective swine IAV control that can be utilized byveterinarians and producers. Genvax Technologies' Phase I project is designed to show it isfeasible to develop the Genvax Sequence Database and Genvax Prescription self-amplifyingRNA (saRNA) Vaccine Platform. Genvax will conduct swine IAV surveillance in productionfacilities and incorporate the collected sequence data into a centralized repository. The GenvaxSequence Database will be used to create predictive machine-learning (ML) models of viralevolution to improve vaccine design. We will create the first system that allows individualproducers to have predictive analytics for viral changes within their farm. Using swine IAV HAsequences from Iowa Farms in 2018 as input we could accurately predict sequences occurringfor the following two years (2019-2020). We propose that with more producer-specific data wecould train customized ML models for individual production systems or farms and forecast theprevalence 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 creatinga prescriptive saRNA nanoparticle vaccine that is designed based on producer-specificsurveillance data within a 4 week turn-around time. Vaccine efficacy will be demonstrated withan in vivo study in pigs. Genvax has fully completed 5 preliminary swine IAV vaccine efficacyproof-of-concept studies in pigs. Briefly pigs vaccinated with saRNA nanoparticle vaccines withHA as the gene of interest generated protective levels of immunity as demonstrated by highHemagglutination Inhibition assay titers and protection from viral challenge.The Genvax team has a long history of entrepreneurship and innovative research. Co-investigatorHank Harris founded Harrisvaccines which developed innovative RNA particle technology thatwas a breakthrough in vaccine development. Genvax technology uses a cell-free encapsulationsystem based on nanoparticle saRNA vaccine delivery. Our goal is to help protect livestock fromcurrent and emerging infectious diseases by providing better solutions to veterinarians andproducers by commercializing our innovative technologies. The global animal health market isprojected to be over $13.6 billion by 2026 with swine vaccines representing $1.8 billion. Asuccessful SBIR project and USDA approval of our vaccine platform will allow Genvax topursue the $400 million U.S. swine vaccine market that includes targeting swine IAV and otherimportant swine pathogens. The development and commercialization of our prop