ORPH.L Regulatory News (ORPH)

5 November 2020

Open Orphan plc

("Open Orphan" or the "Company")

New £2.5m Influenza Challenge Study Contract Win

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 clinical trials is pleased to announce the signing of a £2.5 million contract by hVIVO, a subsidiary of Open Orphan, to conduct an Influenza human challenge study with a US biotechnology company.

The study is expected to commence at hVIVO's 24-bedroom quarantine clinic in East London in H2 2021 and to be fully completed by year end 2021, generating £2.5m of revenue. This contract builds on the Company's recent challenge study contract wins in RSV and COVID-19 and demonstrates the breadth of Open Orphan's service offering and the expertise within the Group as a world leader in its field.

For this study, Venn Life Science's Paris team will complete the biometrics, demonstrating how the various parts of the Open Orphan plc Group can work together to deliver high-quality services to clients. Venn's Paris team are highly regarded in the field as one of the leading providers in this area which is a perfect complement to the London offering.

Cathal Friel, Executive Chairman, Open Orphan, said:

"We are delighted to be conducting this influenza challenge study, recent events have highlighted the importance of treatments for viral infections such as influenza and we are seeing an increased level of interest amongst both pharma and biotech in developing innovative new vaccines, antivirals, and therapeutics.

The Company is pleased to be continuing to deliver on our pipeline of opportunities. This has been due to the exceptional work from the hVIVO team, building on the Company's long history as the world leading challenge study provider. Both the team and I are excited to see the progress being made by the Group and look forward to continuing the momentum as we rapidly grow the business to maximise shareholder value."

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. hVIVO welcomes volunteers to take part in our clinical trials under expertly supervised conditions, to further medical research, and help us to take the understanding of respiratory illnesses to a new level. Volunteers are central to the work that we do; our studies focus on testing new treatments on real people, in a safe, controlled, clinical environment.

Further details on all aspects of our volunteer programs including testimonials from previous volunteers can be found at www.flucamp.com.

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.

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 the 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.