FARMINGDALE, N.Y., June 14, 2022 /PRNewswire/ — Codagenix Inc., a clinical-stage synthetic biology company with a rational virus design platform for viral vaccines and immuno-oncology therapeutics, today announced that it has completed dosing of its Phase 1 clinical trial to evaluate CodaVax™-H1N1, a universal, live-attenuated influenza vaccine. The randomized, double-blind clinical trial is being conducted in Australia and aims to assess the safety, tolerability and immunogenicity of the vaccine in healthy adults 18-49 years of age.
While existing influenza vaccines must be reformulated each year, CodaVax-H1N1 is a universal influenza vaccine designed to induce protection against all strains of influenza by safely leveraging the unique and proven benefits of live-attenuated vaccines, which induce strong cellular immunity and durable antibody responses. CodaVax-H1N1, like all Codagenix vaccines, has been developed using a proprietary and exclusive codon-deoptimization platform to present all antigens of the naturally occurring virus, while hindering replication activity within the host by introducing hundreds of mutations that code for naturally non-preferred codons. Pre-clinical data have demonstrated the potential of CodaVax-H1N1 to induce an antibody response to stalk antigens from a divergent high-path H5 strain in non-human primates. CodaVax-H1N1 is produced via cell-based manufacturing, which is amenable to rapid scale-up and eliminates the need for costly egg-based production.
“Current influenza vaccines provide inadequate protection against varied seasonal strains or those that threaten to cause a pandemic. We are excited to continue this Phase 1 trial to evaluate the safety and immunogenicity of CodaVax-H1N1—bringing us one step closer to delivering a universal and broadly accessible solution that does not require annual reformulation,” said J. Robert Coleman, Ph.D., Co-founder and Chief Executive Officer of Codagenix. “CodaVax-H1N1 is well-suited for cost-effective manufacturing at commercial scales, ensuring it is readily available and accessible for global distribution.”
The Phase 1 trial enrolled 45 patients total across three cohorts of escalating dose to receive intramuscular vaccinations, with roughly nine patients receiving CovaVax-H1N1 at each dose level, nine patients receiving placebo and nine patients receiving a licensed seasonal influenza comparator vaccine. The primary endpoints of the study are determination of reactogenicity and adverse events stemming from vaccination, with a secondary endpoint to assess humoral immune responses elicited by intramuscular injection with CodaVax-H1N1.
About Codagenix, Inc.Codagenix is a clinical-stage biotechnology company leading a new era of live vaccines and viral therapeutics. The company’s breakthrough platform brings together live-attenuated virus design with cutting-edge codon deoptimization for powerful synthetic biology-based solutions to take on our biggest threats in infectious disease, cancer and animal health. Codagenix was founded based on technology developed in the laboratory of National Academy of Science member Dr. Eckard Wimmer at Stony Brook University; is supported by Adjuvant Capital, TopSpin Partners, and Euclidean Capital; and has ongoing research and license programs with various federal agencies. For more information, visit codagenix.com.