RE: Imutex11 May 2020 01:10
Open Orphan
Cathal Friel, the chairman of Open Orphan, calls hVivo his “lucky acquisition”. HVivo specialises in viral study models and testing the efficacy of vaccines. The company owns a 24-bedroom quarantine clinic in London.
The AIM-quoted Open Orphan bought hVivo “because it looked cheap”, says Friel. About £113m (€130m) has been invested in the clinic, viral testing models and a universal flu vaccine. While structured as a merger, Open Orphan in effect bought hVivo for £13m. It was an “unloved company” in an unfashionable corner of the pharma services sector, according to Friel — but not any more.
“In truth, in the past number of years there hasn’t been a lot of money spent on developing vaccines — it’s been all talk and no action,” he says. “In the past six weeks, suddenly, being a world leader in viral studies and testing has become a very interesting place.”
Last week Open Orphan announced its involvement in an antiviral treatment trial for Covid-19 with Russian pharma outfit Nearmedic International. It is in talks with eight pharma firms about using its facilities to mount a “human challenge” study on potential vaccine candidates. As such, it could play an integral part in bringing a vaccine to market quickly.
Normally, the efficacy of a vaccine candidate is tested in field studies, where the treatment and a placebo are given to thousands — or even tens of thousands — of people. Reseachers monitor those who get infected and how they react.
These phase III field studies are complex and time-consuming, and often the longest part of a vaccine’s development. With Covid-19, the focus of the health authorities and the public is to suppress the natural spread of the virus, which may frustrate the field study.
With a human challenge study, a small sample of people, perhaps 100 to 150 , are given the vaccine candidate or a placebo. All subjects are then infected with an attenuated strain of coronavirus a month later, and monitored in a quarantined environment for 10 days. Nir Eyal, director of the centre for population-level bioethics at Rutgers University in New Jersey, told Nature publication that human challenge studies could “greatly accelerate the time to approval and potential use” of a coronavirus vaccine.
The hVivo clinic has a virology laboratory and is one of only two such private facilities in Europe.
Friel said volunteers would be selected from the lowest-risk, healthiest cohorts. The clinic will have access to a full array of antiviral treatments, if necessary. “Over a three-month period, we can have 140 patients tested,” says Friel.
An ethical concern exists about challenging humans with even a weakened strain of a potentially deadly virus. Eyal says society lets “humans volunteer to do risky things” all the time. “We let people volunteer to be emergency medical services during this period. That significantly elevates their risk of getting infected.”
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