Open Orphan plc (LON:ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, has announced that hVIVO, a subsidiary of Open Orphan, has signed a £10.4m contract with an existing top 5 global pharmaceutical client to manufacture a new batch of H1N1 influenza challenge virus, leveraging off an existing in-house generated challenge model, and to conduct a human challenge trial to test the client’s antiviral product.
hVIVO has world-leading expertise in challenge agent manufacture, with the ability to manufacture specific subtypes of viruses, as well as unrivalled experience in conducting challenge studies. Since the COVID-19 pandemic, the Company has seen an increase in the number of clients looking to test their vaccines and antivirals against specific subtypes of viruses that are circulating in the population or that have the potential to be widely spread. As a result, there is a greater interest in end-to-end human challenge contracts such as this, that include a novel challenge agent manufacture and a challenge study.
The study will evaluate the efficacy profile of the antiviral against the specific influenza subtype, generating data quickly and efficiently. This is the third human challenge contract signed with this client, highlighting the Company’s world leading expertise and the clear benefits of human challenge trials to Big Pharma’s drug development process.
Good Manufacturing Practice compliant virus manufacturing activities will commence immediately and are expected to complete by Q2 2023. Once completed, hVIVO will conduct a Phase 2a double-blinded placebo-controlled human challenge study which is expected to be completed by Q4 2023. hVIVO will recruit healthy volunteers via the Company’s dedicated volunteer recruitment arm, FluCamp. The majority of revenue from the contract is expected to be recognised during 2023.
Yamin ‘Mo’ Khan, Chief Executive Officer of Open Orphan, said: “We’re delighted to be working again with this top 5 global pharmaceutical company to test its antiviral, using a new influenza strain developed by our highly experienced team. 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. I am confident, that with our highly qualified teams and their clinical development expertise, we are well placed to address the growing infectious disease and respiratory research markets.
“Influenza poses a serious global health threat, causing an estimated 290,000 – 650,000 deaths per year with significant pandemic potential, and as such, the development of new vaccines and antivirals to fight flu remains vitally important.”
Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: “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. 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. The resulting data can then indicate whether the candidate is viable for Phase II/III studies, providing substantial time and financial savings compared to traditional field-based studies.”