TIDMORPH
RNS Number : 5423C
Open Orphan PLC
20 October 2020
20 October 2020
Open Orphan plc
("Open Orphan" or the "Company")
Open Orphan/hVIVO Signs Contract with UK Government for the
Development of a COVID-19 Human Challenge Study Model
COVID-19 human challenge study model to safely speed up
development of an efficacious vaccine.
hVIVO has the world's leading portfolio of 8 human challenge
study models developed to date and has safely run more human
challenge studies than any other company globally
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 studies,
is pleased to announce the signing of a contract by hVIVO, a
subsidiary of Open Orphan, with the UK Government to develop a
COVID-19 (SARS-CoV-2) human challenge study model. The model
development involves the manufacture of the challenge virus and the
first-in-human characterisation study for this virus. The contract
starts immediately and could be worth approximately GBP10 million
to hVIVO depending upon the final number of volunteers that are
included in the characterisation study. In addition, the Government
has secured the first three slots to test vaccines using hVIVO's
COVID-19 challenge study, which we expect start in 2021, each slot
reservation has been secured at a cost of GBP2.5m each bringing the
total value of these slot reservations to GBP7.5m.
The characterisation study, which is expected to complete in May
2021 and will require regulatory and ethical approval, enables
identification of the most appropriate dose of the challenge virus
for use in future human challenge studies which play a vital role
in helping to develop vaccines and antivirals for infectious
diseases such as COVID-19.
The study will be sponsored by Imperial College London and
conducted by hVIVO at The Royal Free Hospital's specialist research
unit in London, under the scrutiny of highly trained scientists and
medics. hVIVO will also be expanding its Clinical Operations in
London to facilitate work at this site. hVIVO's state of the art,
category 2 facility at Queen Mary's Bioenterprise Centre, London,
will continue to be used to deliver the Company's traditional
challenge study contracts, particularly respiratory syncytial virus
(RSV) and is booked to maximum capacity until Summer 2021.
hVIVO has a long history of successfully delivering human
challenge studies. The Company, formerly called Retroscreen
Virology, was originally established in 1989 as a spin out from
Queen Mary University, London. Prior to this hVIVO's founders
worked at the common cold unit at Harvard Hospital, near Salisbury.
The Salisbury Flu Clinic, as it is more commonly known, has a
history of running human challenge studies since 1945. hVIVO has
the world's leading portfolio of 8 human challenge study models
developed to date and has safely run more human challenge studies
than any other company globally. The expertise built up over this
long history underpins hVIVO position as the market leader in the
provision of human challenge studies.
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.
Cathal Friel, Executive Chairman, Open Orphan, said:
"At Open Orphan we are pleased to be working on behalf of the UK
Government and in partnership with two great institutions, Imperial
College London and The Royal Free Hospital. We look forward to
working with our partners to develop a COVID-19 human challenge
study model which will be used to safely accelerate the discovery
of effective vaccines and antivirals against COVID-19.
"We hope our work will reduce the impact of COVID-19 on
individuals and communities, and our thoughts go out to the many
people whose lives have been affected by the pandemic."
Alok Sharma, Business Secretary, UK Government, said:
"We are doing everything we can to fight coronavirus, including
backing our best and brightest scientists and researchers in their
hunt for a safe and effective vaccine.
"The funding announced today for these ground-breaking but
carefully controlled studies marks an important next step in
building on our understanding of the virus and accelerating the
development of our most promising vaccines which will ultimately
help in beginning our return to normal life."
Conference call for sell-side analysts and investors
The Company will hold a conference call for sell-side analysts
and investors at 11:00 Thursday 22(nd) of
October. Details for the conference call can be found at: https://www.speakservecloud.com/register-for-call/ecd1cd54-503e-4be0-8f00-3d0a0f92b6a1
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 +44 (0)20 7614
Joint Broker) 5900
John Llewellyn-Lloyd / Benjamin Cryer /
Dan Gee-Summons
+44 (0) 20 7220
finnCap plc (Joint Broker) 500
Geoff Nash / James Thompson/ Richard Chambers
Davy (Euronext Growth Adviser and Joint
Broker) +353 (0)1 679 6363
Anthony Farrell
+44 (0)20 3757
Camarco (Financial PR) 4980
Tom Huddart / Hugo Liddy
Notes to Editors - Open Orphan:
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 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.
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