ORPH.L Regulatory News (ORPH)

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF THE UK VERSION OF THE MARKET ABUSE REGULATION (EU) NO.596/2014, WHICH FORMS PART OF UK LAW BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT 2018 ("UK MAR").

Open Orphan plc

("Open Orphan" or the "Company")

£14.7m influenza contract signed

Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces that hVIVO, a subsidiary of Open Orphan plc, has signed a £14.7m contract for an influenza characterisation study and a follow on influenza human challenge study with an existing top five global pharmaceutical client. Revenue from the contract will be recognised across 2022 and 2023.

This follows a challenge virus manufacturing contract signed with the same client, announced on 4 May 2022. Following completion of the challenge agent manufacturing, the characterisation study will identify a dose of the flu challenge agent that causes a safe and reliable infection in healthy volunteers. The study, 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, FluCamp.

As part of the study, hVIVO Labs will develop and validate challenge agent specific assays for the new flu challenge agent to US Food and Drug Administration (FDA), European Medicines Agency (EMA) and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) standards. This includes quantitative polymerase chain reaction (qPCR) for viral load determination, viral infectivity assay and serological assays for antibody level determination.

Following completion of the characterisation study, hVIVO will conduct a human challenge study, expected to commence in Q1 2023. The study will enable the Company to determine the efficacy of a number of different vaccine candidates for the reduction in incidence of symptomatic flu infection and disease severity in healthy volunteers. 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 characterisation study and establishes the best challenge agent dose for safe volunteer inoculation.

Yamin 'Mo' Khan, Chief Executive Officer of Open Orphan, 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. Moreover, we will also be providing full recruitment and laboratory 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.

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."

Interested in becoming a volunteer?

hVIVO recruits many of 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

Open Orphan plc

Open Orphan plc (London and Euronext: ORPH) is a rapidly growing contract research company that is a world leader in testing infectious and respiratory disease products using human challenge clinical trials. The Company provides services to Big Pharma, biotech, and government/public health organisations.

The Company has a leading portfolio of human challenge study models for infectious and respiratory diseases, including the recently established COVID-19 model, and is developing a number of new models, such as Malaria, to address the dramatic growth of the global infectious disease market. The Paris and Breda offices have over 25 years of experience providing drug development services such as biometry, data management, statistics CMC, PK and medical writing to third party clients as well as supporting the London-based challenge studies.

Open Orphan 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 newly opened clinic in Plumbers Row. To recruit volunteers / patients for its studies, the Company leverages its unique clinical trial recruitment capacity via its FluCamp volunteer screening facilities in London and Manchester. The newly opened facilities have expanded the scope of the business to enable the offering of Phase I and Phase II vaccine field trials, PK studies, bridging studies, and patient trials as part of large international multi-centre studies.

Building upon its many years of challenge studies and virology research, the Company is developing an in-depth database of infectious disease progression data. Based on the Company's Disease in Motion® platform, this unique dataset includes clinical, immunological, virological, and digital (wearable) biomarkers.

About Flu

Influenza (flu) is a contagious respiratory illness caused by influenza viruses that infect the nose, throat, and lungs. Seasonal influenza causes significant morbidity and mortality each year and a pandemic influenza continues to pose a worldwide threat. Influenza is a serious global health threat with an estimated 1 billion cases per year, 3-5 million severe cases and 290,000 - 650,000 deaths per year. Healthy volunteer human challenge studies of wild-type influenza play a major role in the development of vaccines and therapeutics against influenza.