Codagenix announced that it has completed dosing in a Phase 1 clinical trial of its intranasal CodaVax-RSV vaccine for the prevention of respiratory syncytial virus (RSV). According to Codagenix, its SAVE (Synthetic Attenuated Virus Engineering) codon deoptimization platform, “results in genetically stable vaccine strains that can engender robust immune responses and be manufactured to scale.” The company is also developing an intranasal vaccine against COVID-19 using the deoptimization technology.
Results from the trial, which compared two dose levels of the live attenuated vaccine to placebo, are expected in the second quarter of 2021. The trial enrolled 6 healthy volunteers in the 18-49 age range and 30 in the 50-75 age range. Initial analysis of the trial data will take place one month post dosing; the final analysis requires researchers to follow the subjects for six months post dosing.
Codagenix Chief Medical Officer Sybil Tasker said, “We are especially pleased that the initial blinded safety data suggest that the vaccine is well tolerated. We saw that CodaVax-RSV generated both strong antibody and cellular immune responses in primate studies, and are looking forward to reviewing the unblinded interim data and communicating topline results in Q2 2021.”
CEO and co-founder J. Robert Coleman commented, “Completion of dosing of this Phase 1 study is an important milestone in the ongoing advancement of CodaVax-RSV, which we believe has significant advantages over other, antigen-based RSV vaccines in development. We are further buoyed by the strong IP position protecting our host codon and codon-pair deoptimization platforms for vaccine design in general, and in particular, issued patents covering RSV vaccines, including one directed to codon deoptimization of the F and/or G proteins in deoptimized RSV vaccines.”
Read the Codagenix press release.