Open Orphan PLC Challenge virus manufacturing contract (1945K)
May 04 2022 - 1:01AM
UK Regulatory
TIDMORPH
RNS Number : 1945K
Open Orphan PLC
04 May 2022
Open Orphan plc
("Open Orphan" or the "Company")
Challenge virus manufacturing contract for top 5 global
pharmaceutical client
Open Orphan plc (AIM: ORPH), a rapidly growing specialist
contract research organisation (CRO) and world leader in testing
infectious and respiratory disease products using human challenge
clinical trials, announces that hVIVO , a subsidiary of Open
Orphan, has signed a substantial contract with an existing top 5
global pharmaceutical client to manufacture a virus for use in
human challenge studies.
Virus manufacturing activities have commenced and are expected
to be completed by end of Q3 2022. The Company is optimistic that a
characterisation study and a substantial human challenge study
would follow the completion of the GMP-compliant manufacturing
process. The aim of a characterisation study is to establish the
right dose of the virus that causes a safe and reliable infection
in healthy volunteers. The revenue for the manufacturing process
will be recognised in 2022.
The manufacture of new challenge viruses ensures that hVIVO has
contemporary challenge agents available to meet the needs of the
global pharmaceutical industry as they continue to fight the battle
against infectious disease. Furthermore, this ensures the Company
continues to enhance and expand its offering of human challenge
studies, especially among infectious diseases where variants
continually emerge and are often poorly understood.
Yamin 'Mo' Khan, Chief Executive Officer of Open Orphan, said :
"We are delighted to have secured this challenge virus
manufacturing contract, from an existing Big Pharma client. This
contract is testament to our world-class capabilities in the entire
challenge trial process, beginning with virus manufacture, through
to characterisation study and challenge study execution. This
contract illustrates our ability to leverage this to build deep,
long-lasting relationships with our clients over significant
periods of time.
"This contract is also a further example of the Company's
ability to secure repeat contracts from its existing base of Big
Pharma clients, who have great confidence in our decades of world
leading clinical trial experience. With this experience coupled
with our expanded offering following the facilities expansion, I
look forward to providing further clinical services support to the
significantly enlarged and growing infectious and respiratory
disease market."
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 . 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.
Individuals interested in taking part in COVID-19 human
challenge study research can learn more at www.UKCovidChallenge.com
.
For further information please contact:
Open Orphan plc +353 (0) 1 644 0007
Cathal Friel, Executive Chairman
Yamin Khan, Chief Executive Officer
Liberum Capital (Nominated Adviser
and Joint Broker) +44 (0) 20 3100 2000
Ben Cryer/ Edward Mansfield/ Phil
Walker/ Will King
finnCap plc (Joint Broker) +44 (0) 20 7220 0500
Geoff Nash / James Thompson / Richard
Chambers
Davy (Euronext Growth Adviser and
Joint Broker) +353 (0) 1 679 6363
Anthony Farrell
Walbrook PR (Financial PR & IR) +44 (0)20 7933 8780 or openorphan@walbrookpr.com
Paul McManus / Sam Allen / Louis +44 (0)7980 541 893 / +44 (0) 7502 558
Ashe-Jepson 258 /
+44 (0) 7747 515393
Notes to Editors
Open Orphan plc (London and Euronext: ORPH) is a rapidly growing
contract research company that is a world leader in testing
infectious and respiratory disease products using human challenge
clinical trials. The Company provides services to Big Pharma,
biotech, and government/public health organisations.
The Company has a leading portfolio of human challenge study
models for infectious and respiratory diseases and is developing a
number of new models, such as malaria and COVID-19, to address the
dramatic growth of the global infectious disease market. The Paris
and Breda offices have over 25 years of experience providing drug
development services such as biometry, data management, statistics
CMC, PK and medical writing to third party clients as well as
supporting the London-based challenge studies.
Open Orphan runs challenge studies in London from its
Whitechapel quarantine clinic, its state-of-the-art QMB clinic with
its highly specialised on-site virology and immunology laboratory,
and its newly opened clinic in Plumbers Row. To recruit volunteers
/ patients for its studies, the Company leverages its unique
clinical trial recruitment capacity via its FluCamp volunteer
screening facilities in London and Manchester. The newly opened
facilities have expanded the scope of the business to enable the
offering of Phase I and Phase II vaccine field trials, PK studies,
bridging studies, and patient trials as part of large international
multi-centre 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(R) platform, this unique dataset includes clinical,
immunological, virological, and digital (wearable) biomarkers.
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