CodaVax™ RSV Vaccine May 2023
CodaVax™-RSV intranasal, live-attenuated vaccine candidate has the potential to induce innate immunity and durable local and systemic immunity.
Codagenix Inc. is utilizing codon-deoptimized live vaccine candidates to deliver all the benefits of live vaccines on short timelines while offering unparalleled genetic stability. Codagenix's "death by a thousand cuts" approach takes the genetic sequence of the wild-type target and uses an AI-aided algorithm to compute the hundreds or thousands of sites where codons can be modified to produce the same amino acid sequence with lower translational efficiency. This process yields a small, testable number of candidate viral genomes that produce all the same proteins as the wild type but with far less virulence, exponentially accelerating timelines for candidate development. In addition, unlike previous live-attenuated RSV vaccine candidates, CodaVax-RSV is highly stable due to genetic edits that prevent wild-type reversion.
On May 10, 2023, Codagenix announced that it initiated dosing in a pediatric Phase 1 study evaluating the CodaVax™-RSV vaccine as an age de-escalation, dose-escalation design specifically evaluating safety and immunogenicity in the 6-month to 5-year-old population. The trial is being conducted under U.S. FDA IND and Fast Track designations.
New York-based Codagenix is a clinical-stage biotechnology company leading a new era of live vaccines and viral therapeutics.
CodaVax Indication
CodaVax is indicated to prevent (RSV) infections in infants and adults. RSV is a leading cause of hospitalization due to acute lower respiratory infection, particularly in infants, young children, and elderly adults.
CodaVax News 2023
May 10, 2023 - "Codagenix is focused on providing an effective prophylactic vaccine for infants and toddlers six months to 5 years old who, based on the recent data, may be at higher risk for hospitalization following infection despite recent innovations in other RSV vaccines for the elderly that are under review," said J. Robert Coleman, Ph.D., Co-founder and Chief Executive Officer of Codagenix.
November 2, 2022 - The US FDA has granted Codagenix Fast Track Designation for CodaVax-RSV, an intranasal RSV vaccine candidate.
June 1, 2022 - Codagenix Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for CodaVaxTM-RSV.
CodaVax Clinical Trials
CodaVax has completed a phase 1 clinical trial and will begin recruiting for another phase 1 trial. The first phase 1 clinical trial has been completed: Safety and Immunogenicity of a Live-attenuated Vaccine Against Respiratory Syncytial Virus in Elderly Volunteers. This trial began on July 10, 2020, enrolling 36 healthy adult volunteers. The participants received two doses, 28 days apart. The vaccine was administered as nose drops.
The second phase 1 study - CodaVax-RSV in Seropositive and Seronegative Children, was Last Updated on April 20, 2023.
