ORPH.L Regulatory News (ORPH)

Open Orphan plc

("Open Orphan" or the "Company")

Launch of STRiVE project

Respiratory viral strains suitable for challenge agents being collected from consenting volunteers

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 recently launched the STRiVE project (Seasonal Transmissible Respiratory Virus SurvEy) to collect respiratory viral strains suitable for challenge agents from consenting hVIVO employees. Collection of new respiratory viral strains circulating in the community will allow hVIVO to continually update and broaden its world leading portfolio of human challenge study models.

As part of STRiVE, volunteers with cold or flu like symptoms can send nasal swabs to hVIVO for analysis. Since starting the project, hVIVO has identified over 180 promising virus candidates that could be used in the manufacture of novel challenge agents for its human challenge trials. Viruses isolated include several strains of coronavirus, adenovirus, human metapneumovirus (HMPV), human rhinovirus (HRV), parainfluenza virus (PIV), influenza, and respiratory syncytial virus (RSV).

STRiVE ensures hVIVO can regularly update its challenge agent portfolio with relevant strains as viruses mutate over time. Manufacturing antigenically relevant strains on demand broadens hVIVO's repository of viral pathogens and could help extend the range of human challenge models it currently offers.

The average UK adult has an estimated 2-4 respiratory infections each year, resulting in billions of pounds of lost output due to illness. Despite familiarity with the negative impacts of cold and flu viruses, remarkably little is understood about the hundreds of viruses responsible that cause illness, including transmission and markers of protective immunity. Using human challenge modelling to better understand such issues could enable future public health benefits and savings.

hVIVO has two decades of experience and expertise in safely conducting challenge studies across a range of respiratory and infectious diseases, including various strains of influenza, RSV, human rhinovirus (HRV - common cold virus), malaria, and asthma. This portfolio has also expanded to include the SARS-CoV-2 virus.

Cathal Friel, Executive Chairman of Open Orphan, said: "Despite only commencing recently, STRIVE has already been a remarkable success, with over 180 viruses identified and 12 different strains, with potential to be used as challenge agents in hVIVO human challenge trials. I would like to thank all hVIVO employees who have thus far participated and encourage more to do so in order to continue to build up this important repository for cold and flu research.

"Importantly, the STRIVE clinical research project will play a significant role in the Company's efforts to broaden its world leading portfolio of human challenge models."

Adrian Wildfire, Director of Scientific and Business Strategy at hVIVO, commented: "Access to viable strains of circulating respiratory pathogens is extremely limited and this often presents a significant obstacle to anyone seeking to grow a new viral challenge agent. To grow a new viral strain a virus must be collected from a human host, processed and stored in an adequate manner to keep the virus alive.

"STRIVE will allow the Company to use its expertise to monitor the viral strains of cold and flu that are circulating in the community, and potentially lead to the discovery of new, wild type challenge agents and the development of new human challenge models with unparalleled translation into the field."

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.

Individuals interested in taking part in COVID-19 human challenge study research can learn more at www.UKCovidChallenge.com.

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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 vaccines and antivirals using human challenge clinical trials. The Company provides services to Big Pharma, biotech and government/public health organisations.

Open Orphan runs challenge studies in London from both its 19-bedroom Whitechapel quarantine clinic and its state-of-the-art 24-bedroom QMB clinic with its highly specialised on-site virology and immunology laboratory. The Company has a leading portfolio of human challenge study models for infectious and respiratory diseases and is developing a number of new models. There has been an explosion in the growth of the infectious disease market, which is estimated to grow to in excess of $250bn by 2025. The Group is focused on refreshing its existing challenge models and develop new models, such as Malaria, to address the dramatic growth potential of the global infectious disease market.

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. The Disease in Motion platform has many potential applications across a wide variety of end users including big technology, wearables, pharma and biotech companies.

Open Orphan's Paris office has been providing biometry, data management and statistics to its many European pharmaceutical clients for over 20 years. For over 15 years, the Company's Netherlands office has been providing drug development consultancy and services, including CMC (chemistry, manufacturing and controls), PK and medical writing, to a broad range of European clients. Both offices are now also fully integrated with the London office and working on challenge study contracts as well as supporting third party trial contracts.