TIDMORPH
RNS Number : 9935X
Open Orphan PLC
10 May 2021
Open Orphan plc
("Open Orphan" or the "Company")
GBP3m COVID-19 challenge virus manufacturing contract
hVIVO to develop challenge agent based on new COVID-19
variants
Open Orphan plc (AIM: ORPH), a rapidly growing specialist
pharmaceutical services contract research organisation (CRO) and
world leader in vaccine and antiviral testing using human challenge
clinical trials, announces that hVIVO, a subsidiary of Open Orphan
plc, has signed a contract with Imperial College London, as part of
a Wellcome Trust funded initiative to manufacture a SARS-CoV-2
challenge virus.
The contract is worth GBP3 million and under this agreement
hVIVO will develop a new SARS-CoV-2 challenge virus based on new
emerging variants of the virus, which will be used in future hVIVO
run human challenge trials to allow direct comparisons of vaccines
or antivirals against different COVID-19 variants.
The manufacturing project will begin immediately and is expected
to complete before the end of 2021. Following completion of the
manufacturing project there is the potential for a follow on
characterisation study for this virus to be conducted by hVIVO in
partnership with Imperial and Wellcome.
hVIVO has two decades of experience and expertise in challenge
agent (virus) manufacture across a range of respiratory viruses
including various strains of influenza, Respiratory Syncytial Virus
(RSV), human Rhinovirus hRV (common cold virus), as well as a more
recently the initial circulating SARS-CoV-2 virus. These challenge
agents are then used in controlled human infection studies, an area
that hVIVO has focussed on since 2001.
Open Orphan has successfully initiated the development of a
number of Coronavirus challenge viruses. The Company has already
developed the initial circulating COVID-19 (SARS-CoV-2) virus as
part of the Human Challenge Programme in partnership with the UK
Government.
Cathal Friel, Executive Chairman of Open Orphan plc commented:
"This contract is a great example of how our unique abilities to
provide an all encompassing solution for human challenge trials
sets us apart. We are able to support our customers from the very
beginning of the process by developing challenge study models,
including the manufacture of the challenge virus, as well as taking
responsibility for full trial recruitment and using our London
based quarantine facilities to run the human challenge studies
themselves."
Dr Andrew Catchpole, Chief Scientific Officer, hVIVO commented:
"We are delighted to be able to utilise our extensive experience in
challenge virus production at hVIVO to aid this important programme
in meeting its aims. Production of a SARS-CoV-2 variant challenge
virus builds upon our knowledge and learnings from manufacturing
and characterising the original Wuhan-like D614G SARS-CoV-2 virus.
The availability of a variant SARS-CoV-2 virus will greatly expand
the utility of the SARS-CoV-2 challenge model and allow us to
answer a wider range of important scientific questions to aid
control of the pandemic as well as facilitate further testing of
vaccines designed against COVID-19."
Dr Chris Chiu, Imperial College London commented: "We are
pleased to be embarking on this new phase in development of the
SARS-CoV-2 human challenge model with hVIVO. By keeping up with
viral evolution, we will be able to address even more relevant
scientific questions and test the ability of immune responses after
vaccination and infection to protect against different strains of
SARS-CoV-2. We are committed to enhancing collaboration through
sharing of this virus with academic investigators around the world
who have capacity to conduct human infection challenge for academic
purposes, thus further enhancing the pandemic response."
Interested in becoming a volunteer?
Individuals interested in taking part in COVID-19 human
challenge study research can learn more 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.
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:
Open Orphan plc +353 (0) 1 644 0007
Cathal Friel, Executive Chairman
Arden Partners plc (Nominated Adviser
and Joint Broker) +44 (0) 20 7614 5900
John Llewellyn-Lloyd / Benjamin Cryer
/ Nick Wright
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 & +44 (0)20 7933 8780 or openorphan@walbrookpr.com
IR)
Paul McManus / Louis Ashe-Jepson / +44 (0)7980 541 893 / 07747
Sam Allen 515 393 / 07502 558 258
Notes to Editors
Open Orphan plc (London and Euronext: ORPH) is a rapidly growing
pharmaceutical service/contract research company that is a world
leader in testing vaccines and antivirals using human challenge
clinical trials. The company provides services to Big Pharma,
biotech and government/public health organisations.
Open Orphan runs challenge studies in London from both its
19-bedroom Whitechapel quarantine clinic, opened in February 2021,
and its 24-bedroom QMB clinic which also has a highly specialised
virology and immunology laboratory on-site. Open Orphan has a
leading portfolio of eight human challenge study models for
conditions such as RSV, flu, asthma and COPD. In addition, Open
Orphan is also developing the world's first COVID-19 human
challenge study model as part of the Human Challenge Programme and
has signed a reservation contract with the UK Government for the
first three COVID-19 vaccine challenge 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. The
Disease in Motion platform has many potential applications across a
wide variety of end users including big technology, wearables,
pharma and biotech companies. Following COVID-19 there is now a
renewed interest and investment in infectious diseases.
Open Orphan's Paris office has been providing biometry, data
management and statistics to its many European pharmaceutical
clients for over 20 years. For over 15 years, the Company's
Netherlands office has been providing drug development consultancy
and services, including CMC (chemistry, manufacturing and
controls), PK and medical writing, to a broad range of European
clients. Both offices are now also fully integrated with the London
office and working on challenge study contracts as well as
supporting third party trial contracts .
Wellcome Trust
Wellcome supports science to solve the urgent health challenges
facing everyone. We support discovery research into life, health
and wellbeing, and we're taking on three worldwide health
challenges: mental health, global heating and infectious
diseases.
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