hVIVO Regulatory News (HVO)

hVIVO plc

("hVIVO" or the "Company")

hVIVO to develop human metapneumovirus (hMPV) challenge model

First client of the new hMPV model secured

hVIVO plc (AIM & Euronext: HVO), (formerly Open Orphan plc) a rapidly growing specialist contract research organisation and world leader in testing infectious and respiratory disease products using human challenge clinical trials, is developing a human metapneumovirus (hMPV) challenge model. hVIVO has signed an agreement with a North American biopharmaceutical company to manufacture a hMPV virus and conduct a characterisation study, with the intent to conduct a subsequent hMPV challenge trial in 2024 to test the efficacy of its vaccine candidate.

hVIVO will commence Good Manufacturing Practice (GMP) compliant virus manufacturing activities immediately and this is expected to complete in H1 2024. The Company will then conduct a characterisation study to identify a safe and infectious dose of wild-type hMPV in up to 36 healthy adult volunteers. Dependent on the successful completion of the characterisation study and receipt of relevant regulatory approvals, the Company expects to conduct hMPV challenge trials from H2 2024. The majority of the revenue from this end-to-end human challenge service will be recognised in 2024.

The client intends to utilise the efficacy data from the challenge study to define the endpoints for its hMPV vaccine candidate's clinical development programme, as well as providing a greater understanding of virus progression, aiding dosing decisions and confirming previous animal study results. This will allow the client to streamline future trials and make critical go/no-go decisions more quickly, therefore accelerating the development of the vaccine candidate.

hMPV is a common virus that causes an upper respiratory infection, similar to the common cold. Symptoms include cough, fever, nasal congestion, and shortness of breath. Most people have mild cases of hMPV, but severe cases can result in bronchiolitis, bronchitis and pneumonia. hMPV is associated with approximately 20% of respiratory tract infections in children worldwide1. Up to 16% of the children infected with hMPV develop more severe symptoms2, with over 16,000 deaths worldwide in children under the age of five each year.3 Despite its prevalence and potential severity, there are currently no vaccines or antivirals approved to treat hMPV.4

Yamin 'Mo' Khan, Chief Executive Officer of hVIVO, said: "We are delighted to be developing the industry's first commercial hMPV human challenge model. The continued expansion of our challenge model portfolio aligns with our mission to deliver today's healthcare by empowering tomorrow's innovation. We hope to help our client to bring their treatment to patients faster through the utilisation of a new unique human challenge model. We will continue to expand our library of challenge models and provide a mechanism for our customers to expedite their drug development."

Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: "hVIVO's unique expertise and world leading capabilities enables us to provide our clients with a full human challenge service offering, including the development of bespoke challenge models. As demonstrated with RSV, hVIVO can also play a vital role in speeding up drug development for hMPV, which currently has no approved vaccine or antiviral treatment."

1 https://www.sciencedirect.com/topics/immunology-and-microbiology/human-metapneumovirus

2 Howard LM, et al. 2021

3 Wang X, et al. 2021

4 CDC

Interested in becoming a volunteer?

hVIVO recruits its volunteers for its challenge study clinical trials through its dedicated volunteer recruitment website, www.flucamp.com. By volunteering to take part in one of our studies in a safe, controlled, clinical environment under expertly supervised conditions you are playing your part to further medical research and help increase the understanding of respiratory illnesses.

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Notes to Editors

About hVIVO

hVIVO plc (ticker: HVO) (formerly Open Orphan plc) is a rapidly growing specialist contract research organisation (CRO) and the world leader in testing infectious and respiratory disease vaccines and therapeutics using human challenge clinical trials. The Group provides end-to-end early clinical development services to its large, established and growing repeat client base, which includes four of the top 10 largest global biopharma companies.

The Group's fast-growing services business includes a unique portfolio of 11 human challenge models, with a number of new models under development, to test a broad range of infectious and respiratory disease products. The Company has world class challenge agent manufacturing, specialist drug development and clinical consultancy services via its Venn Life Sciences brand, and a lab offering via its hLAB brand, which includes virology, immunology biomarker and molecular testing. The Group offers additional clinical field trial services such as patient recruitment and clinical trial site services.

hVIVO runs challenge studies in London from its Whitechapel quarantine clinic, its state-of-the-art QMB clinic with its highly specialised on-site virology and immunology laboratory, and its clinic in Plumbers Row. To recruit volunteers / patients for its studies, the Company leverages its unique clinical trial recruitment capability via its FluCamp volunteer screening facilities in London and Manchester.