Codagenix Inc. today announced that it has completed dosing of its Phase 1 clinical trial to evaluate CodaVax™-H1N1, a universal, live-attenuated influenza vaccine.
| Trial is assessing safety and immunogenicity of intramuscular, live-attenuated influenza vaccine, CodaVax™- H1N1, in healthy adults 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. Initial results from this study are anticipated in Q4 2022. Visit clinicaltrials.gov for additional information (NCT05223179). About Codagenix, Inc.
SOURCE Codagenix, Inc. |
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