ORPH.L Regulatory News (ORPH)

20 October 2020

Open Orphan plc

("Open Orphan" or the "Company")

Open Orphan/hVIVO Signs Contract with UK Government for the Development of a COVID-19 Human Challenge Study Model

COVID-19 human challenge study model to safely speed up development of an efficacious vaccine.

hVIVO has the world's leading portfolio of 8 human challenge study models developed to date and has safely run more human challenge studies than any other company globally

Open Orphan plc (ORPH), a rapidly growing specialist CRO pharmaceutical services company, which is the world leader in the testing of vaccines and antivirals using human challenge studies, is pleased to announce the signing of a contract by hVIVO, a subsidiary of Open Orphan, with the UK Government to develop a COVID-19 (SARS-CoV-2) human challenge study model. The model development involves the manufacture of the challenge virus and the first-in-human characterisation study for this virus. The contract starts immediately and could be worth approximately £10 million to hVIVO depending upon the final number of volunteers that are included in the characterisation study. In addition, the Government has secured the first three slots to test vaccines using hVIVO's COVID-19 challenge study, which we expect start in 2021, each slot reservation has been secured at a cost of £2.5m each bringing the total value of these slot reservations to £7.5m.

The characterisation study, which is expected to complete in May 2021 and will require regulatory and ethical approval, enables identification of the most appropriate dose of the challenge virus for use in future human challenge studies which play a vital role in helping to develop vaccines and antivirals for infectious diseases such as COVID-19.

The study will be sponsored by Imperial College London and conducted by hVIVO at The Royal Free Hospital's specialist research unit in London, under the scrutiny of highly trained scientists and medics. hVIVO will also be expanding its Clinical Operations in London to facilitate work at this site. hVIVO's state of the art, category 2 facility at Queen Mary's Bioenterprise Centre, London, will continue to be used to deliver the Company's traditional challenge study contracts, particularly respiratory syncytial virus (RSV) and is booked to maximum capacity until Summer 2021.

hVIVO has a long history of successfully delivering human challenge studies. The Company, formerly called Retroscreen Virology, was originally established in 1989 as a spin out from Queen Mary University, London. Prior to this hVIVO's founders worked at the common cold unit at Harvard Hospital, near Salisbury. The Salisbury Flu Clinic, as it is more commonly known, has a history of running human challenge studies since 1945. hVIVO has the world's leading portfolio of 8 human challenge study models developed to date and has safely run more human challenge studies than any other company globally. The expertise built up over this long history underpins hVIVO position as the market leader in the provision of human challenge studies.

If you are interested in being contacted and provided with details about future COVID-19 human challenge study research, please leave your contact details at www.UKCovidChallenge.com.

Cathal Friel, Executive Chairman, Open Orphan, said:

"At Open Orphan we are pleased to be working on behalf of the UK Government and in partnership with two great institutions, Imperial College London and The Royal Free Hospital. We look forward to working with our partners to develop a COVID-19 human challenge study model which will be used to safely accelerate the discovery of effective vaccines and antivirals against COVID-19.

"We hope our work will reduce the impact of COVID-19 on individuals and communities, and our thoughts go out to the many people whose lives have been affected by the pandemic."

Alok Sharma, Business Secretary, UK Government, said:

"We are doing everything we can to fight coronavirus, including backing our best and brightest scientists and researchers in their hunt for a safe and effective vaccine. 

"The funding announced today for these ground-breaking but carefully controlled studies marks an important next step in building on our understanding of the virus and accelerating the development of our most promising vaccines which will ultimately help in beginning our return to normal life."

Conference call for sell-side analysts and investors

The Company will hold a conference call for sell-side analysts and investors at 11:00 Thursday 22nd of October. Details for the conference call can be found at: https://www.speakservecloud.com/register-for-call/ecd1cd54-503e-4be0-8f00-3d0a0f92b6a1 

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.

For further information please contact

Notes to Editors - Open Orphan:

Open Orphan is a rapidly growing niche CRO pharmaceutical services company which is a world leader in the testing of vaccines and antivirals through the use of human challenge clinical trials. Conducted from Europe's only 24-bedroom quarantine clinic with onsite virology providing individually isolated rooms and connected to our specialist laboratory facility. hVIVO's challenge studies require healthy volunteers to take part, volunteers are recruited through FluCamp, learn more at www.FluCamp.com. The hVIVO facility offers highly specialised virology and immunology laboratory services to support pre-clinical and clinical respiratory drug, antiviral, and vaccine discovery and development. Reliable laboratory analysis underpinned by scientific expertise is essential when processing and analysing clinical samples. Robust quality processes support our team of scientists in the delivery of submission ready data.

The Company has a leading portfolio of 8 viral challenge study models which are: 2 FLU, 2 RSV, 1 HRV, 1 Asthma, 1 cough and 1 COPD viral challenge models. As announced in early March, Open Orphan is rapidly advancing a number of Coronavirus challenge study models and expects to be helping many COVID-19 vaccine development companies to test their vaccines. No other company in the world has such a portfolio, with only two competitors globally having 1 challenge study model each. hVIVO also works with companies in the UK and Ireland to provide COVID-19 testing to staff to protect staff and customers from a workplace COVID-19 outbreak through its COVID Clear offering. 

Open Orphan comprises of two commercial specialist CRO services businesses, hVIVO  and  Venn Life Sciences and is also building out a valuable data platform business. hVIVO has built up one of the world's largest databases of infectious disease progression data and we are populating our Open Orphan Health Data platform with this historical hVIVO data. In our clinical trials going forward, we are also planning to collect data on volunteer's via wearables during clinical trials. Therefore, Open Orphan's data, which may yield valuable digital biomarkers, could be one of the more sought-after datasets by many of the large wearables /smart watch wearables providers around the world. In June 2019, Open Orphan acquired AIM-listed Venn Life Sciences Holdings plc in a reverse take-over and in January 2020 it completed the merger with hVIVO plc in January 2020. Venn is an integrated drug development consultancy firm which offers CMC (chemistry, manufacturing and controls), preclinical, Phase I & II clinical trials design and execution. The merger with hVIVO created a European full pharma services company broadening the Company's customer base and with complementary specialist CRO services, widened the range of the Company's service offerings.