ORPH.L Regulatory News (ORPH)

Open Orphan plc

("Open Orphan" or the "Company")

Expansion of volunteer recruitment centres for human challenge trials

Open Orphan plc (AIM: ORPH), a rapidly growing specialist pharmaceutical services clinical research organisation (CRO) and the world leader in vaccine and antiviral testing using human challenge clinical trials, has opened two new volunteer recruitment centres to screen potential trial volunteers, the first in East London and a second in central Manchester. These new locations are part of the Company's expansion of its human challenge study trials launching in 2021.

The first new site is a repurposed former coffee shop at the street level of Queen Mary BioEnterprise Innovation Centre ("QMB"), which houses hVIVO's current 24-bedroom state-of-the-art quarantine clinic in Whitechapel, East London. This is the first time a branded volunteer recruitment centre has been situated at street level whereby volunteers can walk straight in for screening. The large, multi-use space has the capacity to provide substantially more volunteer medical screening and processing with dedicated private physical exam and consenting rooms, ample hot-desking space and a refreshment area, as well as a dedicated reception area. Importantly, this means the facility can now offer 520 volunteer recruitment visit slots per week, with the intention that this will increase over time. This new centre has processed its first volunteers in recent weeks. Learn more about the screening process at www.flucamp.com/what-is-screening/.

The Company has opened another similar volunteer recruitment facility in central Manchester, broadening its reach and reducing travel time required by potential volunteers to attend the initial visit at our London clinic. It will have an initial capacity for more than 100 visits per week, but this will increase substantially in the weeks that follow. The clinic is due to process its first volunteers on 27 January.

Cathal Friel, Executive Chairman of Open Orphan plc commented: "We are delighted to have had the opportunity to get access to these new volunteer recruitment screening centres and to have them fully operational so quickly. The current pandemic has forced many businesses to close and we are able to provide another use for these spaces not currently in use. These spaces presented an opportunity for us to open street level volunteer recruitment centres quickly and efficiently. The number of volunteers required by hVIVO is increasing rapidly in line with the number of studies the company is running, and these two additional centres will allow us to increase our capacity substantially in the year ahead. Given our extensive pipeline of upcoming contracted studies, we are also continuing to explore additional quarantine facilities.

We are proud of our hard working and dedicated team for transforming both of these sites in record time into volunteer recruitment screening centres where we can efficiently process more volunteers than ever before."

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.

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.