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Yamin Khan, CEO of Open Orphan, said influenza causes an estimated 290,000 to 650,000 deaths per year with ‘significant pandemic potential’.
Hvivo has signed a £10.4m contract with a major global pharmaceutical company to test a potential flu treatment.
A subsidiary of Dublin-based pharma services company Open Orphan, Hvivo specialises in human challenge trials. This is the deliberate exposure of human volunteers to infectious agents in a controlled setting, designed to assess the efficacy of vaccines or treatments for clients.
Hvivo’s latest deal will see it manufacture a new batch of H1N1 influenza challenge virus and conduct a human challenge trial to test an oral antiviral product from its pharma client.
Since the beginning of Covid-19, Hvivo has seen an increase in demand from clients looking to test vaccines and antivirals against specific subtypes of viruses that are circulating in the population or those that have the potential to spread widely.
This has resulted in greater interest in end-to-end human challenge contracts such as Hvivo’s latest one, which include manufacturing a novel challenge agent and conducting a challenge study.
Open Orphan CEO Yamin Khan said that the development of new vaccines and antivirals to fight flu “remains vitally important” because influenza causes an estimated 290,000 to 650,000 deaths every year with “significant pandemic potential”.
“This contract is the third challenge study with this client, and our second end-to-end full-service contract overall. Our one-stop shop service offerings from manufacturing bespoke challenge agents to conducting full challenge studies is unique in the market,” said Khan.
Hvivo’s study will evaluate the efficacy of the antiviral against the specific influenza subtype, aiming to generate data quickly and efficiently.
Manufacturing the virus for the study is to begin immediately and is expected to be complete by the second quarter of next year. Once completed, Hvivo will conduct a human challenge study, which is expected to be completed by the last quarter of next year.
Hvivo will recruit healthy volunteers via the company’s dedicated volunteer arm FluCamp.
“This contract is a strong example of where human challenge studies can provide significant value. These studies can quickly and cost-effectively generate efficacy data for our clients in specific viral subtypes,” said Dr Andrew Catchpole, chief scientific officer at Hvivo.
“As illustrated with this contract, our world-class manufacturing capabilities can produce a challenge agent for subtypes that pose a particular global health risk or are already circulating in the population.”
In June, Hvivo said it was developing the world’s first human challenge model involving the Omicron variant of Covid-19. This will be used to test the efficacy of an oral vaccine candidate from biotech company Vaxart.
Last year, Hvivo signed an £8.1m contract to test an inhaled antiviral product as part of its asthma human challenge study. The company was also involved in a Covid-19 human challenge study, which was published in March in the Nature Medicine journal.
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