hVIVO Regulatory News (HVO)

hVIVO plc

("hVIVO" or the "Company")

£13.1m contract with global pharmaceutical client to develop an influenza B virus challenge model

hVIVO plc (AIM & Euronext: HVO), the world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces a £13.1m contract with an existing top five global pharmaceutical client to develop an Influenza B ("Flu B") human challenge model.

Highlights

· Key prerequisite phase of manufacturing virus is complete

· Characterisation trial due to commence in Q4 2023 following completion of manufacturing process

· Supplementary fee to ensure expedited delivery and guaranteed availability of beds

· Potential for a future challenge trial pending a successful characterisation study

The contract scope includes the manufacture of an influenza B challenge virus, a characterisation study, and a supplementary fee to ensure sufficient capacity is available to complete the characterisation trial in an expedited manner. The successful manufacturing of the challenge virus is a prerequisite for the characterisation trial revenue to be delivered, and with the Good Manufacturing Practice (GMP) challenge agent manufacture now in its final stages, the Company will be able to commence the characterisation study in Q4 2023.

The characterisation study aims to identify a dose of influenza B that elicits a safe and reproducible infection in healthy volunteers recruited through the FluCamp platform. Subject to the successful completion of the characterisation study and the receipt of relevant regulatory approvals, the Company expects to conduct an influenza B human challenge trial in H1 2024. Revenue from this human challenge model development contract will be recognised throughout 2023 and 2024.

hVIVO is proud to be the exclusive contract research organisation offering this bespoke human challenge model development services with unparalleled knowledge and expertise in this field spanning back as far as the UK Common Cold Unit. Testing medicines against specific virus strains offer numerous benefits to biopharma clients including the certainty of testing efficacy against specific and new strains of virus.

The Centers for Disease Control and Prevention reports that both influenza A and B can have equally severe symptoms,1 although type B is less prevalent. Similar to type A, influenza B is also highly contagious and can cause life-threatening complications in severe cases. Unlike influenza A viruses, which are known to infect a variety of different species and, therefore, have pandemic potential, influenza B viruses typically only infect humans. Influenza B causes seasonal epidemics and gradually evolves to evade the immune system so, like influenza A viruses, the seasonal vaccine component against influenza B virus needs to be updated frequently to maximise protective efficacy.

Yamin 'Mo' Khan, Chief Executive Officer of hVIVO, said: "This is the second bespoke human challenge model development contract announced in as many months and continues the trend of large contract wins for hVIVO. This existing top five global pharmaceutical client will support the development of a new influenza B challenge model to potentially test its vaccine candidate, in turn furthering our industry leading position by broadening our library of human challenge models. Importantly, the contract also further diversifies our revenue pipeline across challenge agents and provides further visibility of revenue into 2024."

Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: "hVIVO is the only commercial provider of human challenge trial services that can offer human challenge model development services to ensure that challenge models are available to meet the specific needs of our customers. The creation of a Flu B challenge model will potentially allow this top five global pharmaceutical client's vaccine candidate to gain quick efficacy data against a type of influenza which is near impossible to achieve via traditional field trials. This unparalleled efficacy data is extremely valuable, as it can open up new markets and strengthen product label claims, significantly increasing the potential value of existing clinical assets."

1 https://www.healthline.com/health/influenza-b-symptoms

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.