ORPH.L Regulatory News (ORPH)

Open Orphan plc

("Open Orphan" or the "Company")

£3m COVID-19 challenge virus manufacturing contract

hVIVO to develop challenge agent based on new COVID-19 variants

Open Orphan plc (AIM: ORPH), a rapidly growing specialist pharmaceutical services contract research organisation (CRO) and world leader in vaccine and antiviral testing using human challenge clinical trials, announces that hVIVO, a subsidiary of Open Orphan plc, has signed a contract with Imperial College London, as part of a Wellcome Trust funded initiative to manufacture a SARS-CoV-2 challenge virus.

The contract is worth £3 million and under this agreement hVIVO will develop a new SARS-CoV-2 challenge virus based on new emerging variants of the virus, which will be used in future hVIVO run human challenge trials to allow direct comparisons of vaccines or antivirals against different COVID-19 variants.

The manufacturing project will begin immediately and is expected to complete before the end of 2021. Following completion of the manufacturing project there is the potential for a follow on characterisation study for this virus to be conducted by hVIVO in partnership with Imperial and Wellcome.

hVIVO has two decades of experience and expertise in challenge agent (virus) manufacture across a range of respiratory viruses including various strains of influenza, Respiratory Syncytial Virus (RSV), human Rhinovirus hRV (common cold virus), as well as a more recently the initial circulating SARS-CoV-2 virus. These challenge agents are then used in controlled human infection studies, an area that hVIVO has focussed on since 2001.

Open Orphan has successfully initiated the development of a number of Coronavirus challenge viruses. The Company has already developed the initial circulating COVID-19 (SARS-CoV-2) virus as part of the Human Challenge Programme in partnership with the UK Government.

Cathal Friel, Executive Chairman of Open Orphan plc commented: "This contract is a great example of how our unique abilities to provide an all encompassing solution for human challenge trials sets us apart. We are able to support our customers from the very beginning of the process by developing challenge study models, including the manufacture of the challenge virus, as well as taking responsibility for full trial recruitment and using our London based quarantine facilities to run the human challenge studies themselves."

Dr Andrew Catchpole, Chief Scientific Officer, hVIVO commented: "We are delighted to be able to utilise our extensive experience in challenge virus production at hVIVO to aid this important programme in meeting its aims. Production of a SARS-CoV-2 variant challenge virus builds upon our knowledge and learnings from manufacturing and characterising the original Wuhan-like D614G SARS-CoV-2 virus. The availability of a variant SARS-CoV-2 virus will greatly expand the utility of the SARS-CoV-2 challenge model and allow us to answer a wider range of important scientific questions to aid control of the pandemic as well as facilitate further testing of vaccines designed against COVID-19." 

Dr Chris Chiu, Imperial College London commented: "We are pleased to be embarking on this new phase in development of the SARS-CoV-2 human challenge model with hVIVO. By keeping up with viral evolution, we will be able to address even more relevant scientific questions and test the ability of immune responses after vaccination and infection to protect against different strains of SARS-CoV-2. We are committed to enhancing collaboration through sharing of this virus with academic investigators around the world who have capacity to conduct human infection challenge for academic purposes, thus further enhancing the pandemic response."

Interested in becoming a volunteer?

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

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.

The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014 ("MAR"). With the publication of this announcement via a Regulatory Information Service, this inside information is now considered to be in the public domain.

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Notes to Editors

Open Orphan plc (London and Euronext: ORPH) is a rapidly growing pharmaceutical service/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, opened in February 2021, and its 24-bedroom QMB clinic which also has a highly specialised virology and immunology laboratory on-site. Open Orphan has a leading portfolio of eight human challenge study models for conditions such as RSV, flu, asthma and COPD. In addition, Open Orphan is also developing the world's first COVID-19 human challenge study model as part of the Human Challenge Programme and has signed a reservation contract with the UK Government for the first three COVID-19 vaccine challenge 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. The Disease in Motion platform has many potential applications across a wide variety of end users including big technology, wearables, pharma and biotech companies. Following COVID-19 there is now a renewed interest and investment in infectious diseases.

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.

Wellcome Trust

Wellcome supports science to solve the urgent health challenges facing everyone. We support discovery research into life, health and wellbeing, and we're taking on three worldwide health challenges: mental health, global heating and infectious diseases.