Open Orphan strikes £10m deal with UK Gov for COVID-19 study
(AIM:ORPH ) has announced that its subsidiary, hVIVO, has signed a contract with the UK Government to develop a COVID-19 human challenge study model to speed up the development of an efficacious vaccine in a deal that could be worth up to £10 million.
The company, which has established itself as a market leader in the testing of vaccines and antivirals through human challenge clinical trials, said the contract will start immediately.
hVIVO has the world's leading portfolio of 8 human challenge study models developed to date and has safely run more human challenge studies than any other company globally.
The UK Government has secured the first three slots to test vaccines using hVIVO's COVID-19 challenge study, which it expects to start in 2021, each slot reservation has been secured at a cost of £2.5m each bringing the total value of these slot reservations to £7.5m.
The model development involves the manufacturing the challenge virus as well as the first-in-human characterisation study for the virus. Following the group’s achievement of regulatory and ethical approval, the study is expected to be completed in May 2021.
Specifically, the characterisation study enables identification of the most appropriate dose of the challenge virus for use in future human challenge studies which ORPH said plays a vital role in developing vaccines and antivirals for infectious diseases such as COVID-19.
The study’s volunteers will be between 18 and 30 years old. ‘The idea of this type of trial is to recruit healthy, young people, inoculate them and then subsequently expose them to the virus to determine if the vaccine is effective,’ CNBC wrote of the study model this morning.
The study will be sponsored by Imperial College London and conducted by hVIVO at The Royal Free Hospital's specialist research unit in London under highly trained scientists and medics. hVIVO will expand its Clinical Operations in London to facilitate work at this site.
hVIVO's ‘state of the art’, category 2 facility at Queen Mary's Bioenterprise Centre, London, will continue to be used to deliver its traditional challenge study contracts, particularly respiratory syncytial virus (RSV), and is booked to maximum capacity until Summer 2021.
Shares in Open Orphan have skyrocketed in value by over 400% since April 2020 and opened this morning 7.88% higher at 31.5p following the announcement.
hVIVO has a long history of successfully delivering human challenge studies since being established in 1989 as a spin out from Queen Mary University, London. Its founders worked at the common cold unit at Harvard Hospital, near Salisbury.
The Salisbury Flu Clinic, as it is more commonly known, has a history of running human challenge studies since 1945. Open Orphan said its expertise built up over a long history underpins hVIVO position as the market leader in the provision of human challenge studies.
“We look forward to working with our partners to develop a COVID-19 human challenge study model which will be used to safely accelerate the discovery of effective vaccines and antivirals against COVID-19,” said Cathal Friel, Executive Chairman of Open Orphan.
“The funding announced today for these ground-breaking but carefully controlled studies marks an important next step in building on our understanding of the virus and accelerating the development of our most promising vaccines which will ultimately help in beginning our return to normal life,” said Alok Sharma, Business Secretary of the UK Government.
ORPH announced back in March 2020 that it was developing the world's first commercial human coronavirus challenge study model, known as Controlled Human Infection Model.
The Financial Times reported in late September 2020 that Open Orphan would be the first company in the world to conduct a human challenge trial for Covid-19 that will see healthy subjects "infected" with the virus to test the effectiveness of the vaccines being developed.
As noted today, the UK government has paid three slot reservation payments at £2.5m each for three full COVID-19 human challenge study vaccine trials to be held next year.
In its results for the six months ended 30 June 2020, the group said it had secured larger, more profitable contracts with large pharma and leading vaccine developers globally.
“Earlier this year we set ourselves the target of being profitable in the second half of 2020 and I am delighted to confirm that, despite profitability taking a few months longer than expected, we are on target to be operationally profitable in Q4 2020,” Friel said last month.
Investors should now note that whilst the market has already been informed these COVID-19 challenge studies could be valued between £8-£10m, this additional contract takes the potential value of up to an additional £30m in aggregate, taking the total contract value the Company has signed with the UK Government close to £40m.
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