ORPH.L Regulatory News (ORPH)

Open Orphan plc

("Open Orphan" or the "Company")

New challenge study quarantine clinic

Open Orphan plc (AIM: ORPH), a rapidly growing specialist pharmaceutical services contract research organization (CRO) and world leader in vaccine and antiviral testing using human challenge clinical trials, announces that hVIVO, part of Open Orphan plc, has opened a new quarantine clinic in East London. The new site is based in Whitechapel, directly opposite the Queen Mary BioEnterprise Innovation Centre ("QMB") which houses hVIVO's 24 bedroom unique state-of-the-art FluCamp site and the recently opened new street-level volunteer screening centre. The Whitechapel Clinic will act as an extension of hVIVO`s current QMB site.

The converted 26-bedroom former boutique hotel, which will be known as the Whitechapel Clinic, has the capacity for up to 19 quarantine rooms and will be used as an additional unit for human challenge trials and volunteer recruitment screening. The quarantine rooms are located across three floors of the former hotel, with each level fully converted to include a nurses station on each floor.

The new site, like QMB, will follow the highest safety standards to deliver each clinical study and volunteer screening visit. Of the 19 rooms, 8 rooms on a single floor are flexible use clinic rooms, meaning they can be used as either quarantine bedrooms for challenge studies or for volunteer screening visits. Each room at the facility has been fully repurposed to the highest standard, with all volunteer rooms equipped with an en-suite bathroom, TV, wardrobe, and tea & coffee making facilities. This will provide a comfortable space for volunteers during studies. The Whitechapel Clinic, like QMB, is also equipped with a 24-hour security presence and a working hour reception desk.

Cathal Friel, Exexcutive Chairman of Open Orphan plc commented: "Our newest quarantine unit greatly increases our capacity to facilitate hVIVO's pipeline of upcoming studies. Our QMB clinic is now close to full capacity until December 2021, and as such, the newly renovated, state of the art Whitechapel Clinic will allow us to increase our study capacity substantially in the year ahead.

"We have leased the entire former Whitechapel Hotel and managed to convert the space on a very cost efficient basis which is now almost fully booked to capacity for H1 2021. This new facility will be run at the same high standard as our QMB site, and volunteers will be expertly supervised by our highly trained nurses and doctors in a safe and controlled clinical environment."

Interested in becoming a volunteer?

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.

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.

For further information please contact:

About Open Orphan (www.openorphan.com)

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 volunteers 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. 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.