The contract is with Codagenix and 48 adults will volunteer for the clinical trial.
Open Orphan plc (ORPH), a rapidly growing specialist CRO pharmaceutical services company, has won a contract with New York-based Codagenix to conduct a trial into a vaccine for Covid-19.
The trial would evaluate the safety and immunogenicity of a single-dose, intranasal SARS-CoV-2 vaccine candidate in 48 healthy young adult volunteers. It was expected to start in early Autumn, with initial data expected by the end of 2020.
The vaccine is a single-dose, intranasal candidate, and will be trialled at Open Orphan subsidiary Hvivo’s quarantine facility in Whitechapel in London.
“It will help bring a promising vaccine candidate to the public to help combat the COVID-19 pandemic as quickly as possible”
Founded in 2017, Open Orphan is a world leader in the testing of vaccines and antivirals using human challenge clinical trials.
The Dublin-listed company specialises in rare disease and so-called orphan drugs – treatments developed for medical conditions which, because they are so rare, few pharmaceutical companies pursue research into.
“We are proud to be conducting this Phase I study for Codagenix, a leader in their field, as it will help bring a promising vaccine candidate to the public to help combat the COVID-19 pandemic as quickly as possible,” said Cathal Friel, executive chairman of Open Orphan.
“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.
“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 finished.
“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, the company Open Oprhan signed the contract with, is a clinical-stage synthetic biology company that uses software to recode the genomes of viruses, constructing live-attenuated vaccines or viruses to prevent viral infections or treat solid tumours.
Its’ 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.
By Stephen Larkin
Published: 28 July, 2020