Open Orphan Restarts Earlier Coronavirus Vaccine Efforts
London-Listed CRO Talking To Chinese Pharma Backers About Project
Executive Summary
Open Orphan’s hVIVO unit, owner of Europe's only quarantine clinic with an onsite virology lab, has begun the world’s first commercial coronavirus human challenge study.
London-listed Open Orphan PLC has initiated the first commercial human coronavirus challenge study model, reviving a project that was put on ice a few years ago to study common strains related to the newly emerging SARS-CoV-2 virus, with the aim of developing a viable vaccine to fight the spreading pandemic.
The project, that uses a controlled human infection model, will see volunteers deliberately infected with a coronavirus strain as part of the company’s plan to develop a vaccine for COVID-19. The study will be conducted at its subsidiary hVIVO’s 24-bed quarantine clinic in east London.
The project will largely be funded by new Chinese pharmaceutical partner companies who will get a return on their investment from royalties on the sale of the challenge study model, according to Cathal Friel, who is the executive chairman of Open Orphan. Discussions are currently underway with those Chinese groups, he added.
“They need access to a quarantine laboratory at short notice and they need access to these challenge study models and we’ve told them that we’re open for business,” Friel told Scrip. “The deal won’t involve huge amounts of money,” he added. “It will be measured in several millions of pounds, not tens of millions, in return for developing the first coronavirus challenge study model …We cannot give them the IP of our challenge study model, but we can give them a royalty on the sales from the model,” he explained.
Human challenge trials are trials in which participants are intentionally ‘challenged’, whether or not they have been vaccinated, with an infectious disease organism. Open Orphan’s subsidiary hVIVO conducts human challenge studies offering services to both pharmaceutical and biotechnology companies using a range of different clinical trial methodologies across differing viral challenges.
“A couple of years ago, the hVIVO scientific team started a project to potentially develop a coronavirus challenge study model, but after a certain amount of work and effort they suspended this project because they didn’t see sufficient market demand for a coronavirus challenge study model. That situation has now changed,” Friel said.
Its human coronavirus challenge study model will use common coronavirus strains such as OC43 and 229E which are from the same family of viruses as the newly emerged SARS-CoV-2 virus that causes COVID-19.
Unlike SARS-CoV-2, these common coronaviruses have been widespread in the community for many years and cause only a mild cold-like respiratory illness. As such they can be safely administered to volunteers in hVIVO’s highly controlled quarantine clinic, Friel explained.
Open Orphan believes use of common coronavirus strains OC43 and 229E will offer an effective way to obtain fast proof-of-concept data against that virus family, and be used to test the efficacy of both new novel and existing vaccines and antivirals, allowing effective selection of the best candidates and the effective products to be fast-tracked for subsequent field testing against COVID-19.
“COVID-19 is a wild virus strain. It can be compared to a wild horse that cannot at this point be ridden, so you’ve got to use a more docile version, such as OC43 which has been around a long time and has the same characteristics as COVID-19. We previously did a lot of work growing it, so the first thing that you’ve got to do is establish the GMP [good manufacturing practice] then you’ve got to start building analysis on it,” he said.
“Given that COVID-19 is still the prancing wild horse – it’s a wild strain – we won’t go near it. We’re instead starting with a more proprietary strain that will have a lot of the features of COVID-19, and a lot of the characteristics that you can test the vaccine against, and at some stage in the coming weeks or months, should COVID-19 be downgraded from being a containment category level 3 pathogen, at which point it’s in the community and lots of people have it, then we can very swiftly switch horses, so to speak and strap down the wild strain and get it into the clinic and run a challenge study model on it. But at the moment COVID-19 is too dangerous to get it anywhere near human guinea pigs,” he said.