hVIVO, a subsidiary of Open Orphan (ORPH ), has signed a £14.7m contract for an influenza characterisation study and a follow on influenza human challenge study with an existing client.
The study, which will be conducted with an existing client - a top five global pharmaceutical firm - will identify a dose of the flu challenge agent that causes a safe and reliable infection in healthy volunteers. Revenue from the contract is to be recognised across 2022 and 2023.
Today’s news follows a challenge virus manufacturing contract signed with the same client earlier this month. Virus manufacturing activities for this contract have already commenced and are expected to be completed by the end of 3Q with revenue recognised later this year.
The manufacture of new challenge viruses ensures that hVIVO has contemporary challenge agents available to meet the needs of the global pharmaceutical industry, therefore allowing the company to expand its offering of human challenge studies, especially among infectious diseases where variants continually emerge and are often poorly understood, the firm noted.
The characterisation study announced today, which is sponsored by hVIVO, is expected to start in Q3 2022, subject to the relevant regulatory approvals, and will enrol volunteers recruited from the Company’s clinical trial volunteer recruitment arm known as FluCamp.
As part of the study hVIVO will develop and validate challenge agent specific assays for the new flu challenge agent including quantitative polymerase chain reaction (qPCR) for viral load determination, viral infectivity assay and serological assays for antibody level determination.
The work conducted on these assays will also involve government agencies such as the US FDA (FDA), European Medicines Agency (EMA) as well as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use standards.
Following the completion of the characterisation study, hVIVO will conduct a human challenge study, expected to start in 1Q23 to determine the efficacy of different vaccine candidates to reduce the incidence of symptomatic flu infection and disease severity in healthy volunteers.
hVIVO says this will help select which of the candidates to progress further into later stage clinical trials. The vaccine study can be initiated, subject to receipt of the relevant regulatory approvals, as soon as the company completes the infectivity and safety data review from the primary study and establishes the best challenge agent dose for safe volunteer inoculation.
Yamin ‘Mo’ Khan, CEO of Open Orphan, who noted that today’s contract is one of the largest contracts in the history of the company, said: “This is another important milestone for hVIVO in that, in addition to the previously announced manufacture of a bespoke challenge agent, we have now been contracted to conduct the characterisation and the challenge studies with this big pharma customer. We will also be providing full recruitment and lab services.”
“This highlights hVIVO’s unique full-service offering in running complex human challenge studies. Our team has a long history of manufacturing challenge agents and conducting human challenge studies. In regard to challenge studies our experience is unrivalled, our scientific expertise unmatched, and our operational delivery in a class of its own.”
Alex Mann, Senior Director of Clinical Science of hVIVO, Sponsor Representative and Scientific Design Lead, commented: “This major contract win solidifies hVIVO’s position in the market in offering the full spectrum of support to clients, from start to finish of the vaccine and drug discovery process. Furthermore, the development of challenge agent specific assays underlines the skill and expertise of our experienced lab scientific team to validate bespoke assays to international standards for use in good clinical practice (GCP) clinical trials.”
He said: “The threat of influenza has never been greater, with an estimated one billion cases per year. Our continued work to support our clients’ vaccine and antiviral programme’s will support the quick, efficient and cost-effective development of these lifesaving medicines.”
hVIVO, which has seen a steady increase in flu studies over the past 18 months and given the pandemic potential of the flu, expects to see a steady increase of such challenge studies.
Following hVIVO’s recent facility expansions, the business can now offer its services beyond the core challenge study offering such as the recently announced vaccination site contract.
Notably, today’s contract represents hVIVO delivering one of its key objectives which is to utilise all of its services to a single client. In fact, this is the first time hVIVO has been engaged to conduct a study of this kind with all three parts of the contract being covered by its services - the manufacturing part, the characterisation study and the challenge study, respectively.
Khan says the revenue from the contract is expected to be recognised across 2022 and 2023. Shares in Open Orphan were trading 10.17% higher at 16.25p following the announcement.
Looking ahead, Khan told Vox Markets that hVIVO can expect to see more deals of this kind, particularly as the demand for these deals has been accentuated by the recent pandemic.
As the threat of influenza increases, government agencies and biopharmaceutical companies alike will be preparing for a high flu season this winter. In the longer term, Kahn said he is also seeing more research being conducted for flu studies to help prevent future pandemics.
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