Open Orphan PLC (LON:ORPH) said that US biotech Codagenix Inc has commissioned its hVIVO arm to carry out a first-in-human trial of a potentially breakthrough nasal vaccine for coronavirus (COVID-19).
The phase I study of 48 healthy young adults will take place at hVIVO's state-of-the-art quarantine facility in London’s Whitechapel.
Work is expected to begin in the autumn with first data assessing safety and immunogenicity (whether the drug provokes an immune response) expected by the end of the year.
The early-stage clinical assessment will also include a second dose as a surrogate viral challenge at day-28 in the process.
“hVIVO, with its unique quarantine facility, is one of the few organisations in the world that has now publicly stated that it is working on testing COVID-19 vaccines for efficacy using human challenge model clinical trials,” Open Orphan chairman, Cathal Friel said in a statement.
“Today's announcement also shows that hVIVO's quarantine facility is uniquely suited to conducting phase I studies for infectious disease vaccines such as this. Codagenix's expertise in viral design technology, combined with hVIVO's phase I trial capability, gives us confidence that this trial will be successful and a step forward for the world as it seeks to develop a COVID-19 vaccine to bring the pandemic to a close," he added.
Codagenix's CodaVax-COVID vaccine replicates very slowly but contains all SARS-CoV-2 proteins, unlike most other vaccines that only contain the viral spike. This means the inoculation has the potential to induce broad immunity with a single intranasal dose.
Sybil Tasker, Codagenix’s chief medical officer, said the plan was to “move very quickly” into larger phase II/III study if the results of the first-in-man trial were encouraging. Drug manufacturing is being scaled up to support this aim.