Commercialization of a Synthetic, Live-attenuated FMDV Vaccine

This Phase II SBIR seeks to further commercialize a live-attenuated Foot-and-Mouth-Disease Virus (FMDV) vaccine candidate that we succesffully constructed in Phase I via a collaboration with the USDA-Plum Island Animal Disease Center (PIADC; CRADA 58-3K95-4-1688-M). In proof of concept studies we demonstrated that Codagenix's vaccine platform was capable of yielding a highly attenuated and immunogenic FMDV vaccine candidate using a laboratory strain. Now, meeting all of our Phase I deliverables, we have successfully applied our platform to serotype-A24, yielding a field and commerically relevant FMDV candidate vaccine. In Phase II we will focus on the swine testing of our A-24 vaccine strain, as well as use our A24 backbone to construct live vaccine candidates for serotypes O and Asia-1, two prevelant serotypes. With A-24, O, and Asia-1 combined we will havea commerically viable vaccine product that covers >74% of all circulating FMDV. Our technology termed Synthetic Attenuated Virus Engineering (SAVE), "de-optimzies" viral genomes thereby reducing viral translation efficency via hundred of stable silent mutations. This SAVE-deoptimization retains 100% identity to the wildtype protein sequence - yielding a vaccine strain that is highly attenuated and a PERFECT antigenic match to your target. By being disadvantaged for translation within host cells, SAVE-deoptimized vaccine strains are avirulent while preserving highly immunogenic properties since they are antigenically identical to the parental wild type strain. FMDV is endemic in many countries around the globe and has proven to be devastating to livestock, with small outbreaks of FMDV causing nearly $1.5 billion in economic losses. A fast-acting and effective FDMV vaccine is needed to help halt the spread of an outbreak and protect cloven-hoofed livestock such as cattle, sheep, and swine. This is best accomplished with a live attenuated vaccine, such as the one proposed here. To differentiate between between vaccinated from naturally infected animals, our deoptimized A24 vaccine strain contains proprietary DIVA markers developed by our collaborators at PIADC. Since FMDV is a Biosafety-level-3+ pathogen and a select agent, all virus work will be conducted in direct collaboration with the PIADC at their Plum Island facilities.