TIDMORPH
RNS Number : 3586F
Open Orphan PLC
09 March 2020
09 March 2020
Open Orphan Plc
("Open Orphan" or the "Company")
Development of the World's First Human Coronavirus Challenge
Study Model
Open Orphan, the rapidly growing specialist Clinical Research
Organisation ("CRO") pharmaceutical services company whose
London-based subsidiary hVIVO is the world leader in the provision
of virology and vaccine challenge study services, is pleased to
announce that it has commenced the development of the world's first
commercial human coronavirus challenge study model, also known as a
Controlled Human Infection Model (CHIM). The Company has Europe's
only 24-bedroom quarantine clinic with onsite virology lab where
the challenge model will be developed and used. The development of
this coronavirus human challenge study model is being led by
hVIVO's Chief Scientist Andrew Catchpole and his team in
conjunction with Open Orphan's Scientific Advisory Board, which is
led by world-renowned virologist Prof John Oxford, and builds upon
work by hVIVO to potentially develop a Coronavirus challenge study
model several years ago and hVIVO's extensive knowledge in
developing human challenge models.
The Company is in early discussions with King & Wood
Mallesons, acting on behalf of selected Chinese pharmaceutical and
life science clients, to secure funding for the further development
of this Coronavirus challenge study. It is intended that the major
cost of developing this Coronavirus human challenge model will be
primarily funded by new Chinese pharmaceutical partner companies
who will get a return on their investment from royalties on the
sale of this particular challenge study model.
Open Orphan will utilise common coronavirus strains such as OC43
and 229E which are from the same family of viruses as the newly
emerging Covid-19 virus but unlike Covid-19 these common
coronaviruses have been widespread in the community for many years
and cause only a mild cold-like respiratory illness. Consequently,
these common coronaviruses, while closely related to the Covid-19
strain can safely be administered to volunteers in hVIVO's highly
controlled quarantine clinic, staffed by a highly experienced
medical and scientific team who to date have already safely
inoculated over 3,000 volunteers in hVIVO's current range of
respiratory virus challenge models.
For the purposes of the human challenge study model, the common
coronavirus strains such as OC43 and 229E, will provide an
effective tool to obtain fast proof-of-concept data against this
important family of viruses. It can be used to test the efficacy of
both new novel and existing vaccines and anti-virals. This will
allow the effective selection of the best candidates and the
effective products to be fast-tracked for subsequent field testing
against Covid-19. All of the human challenge studies can be run out
of hVIVO's quarantine clinic with onsite virology lab in London.
Once developed, hVIVO will offer its coronavirus challenge study
model as both a standalone service to customers or as part of a
combined Phase 1 and human challenge study that can both be run out
of its London quarantine clinic. Furthermore, hVIVO can also offer
services in early phase vaccine development.
This news follows an announcement on Friday 6 March that the
Company had signed a contract with a new client, which is a
European Biotech company, for the provision of an RSV human
challenge study. This study is projected to deliver GBP3.2m in
revenue, all of which is expected to be recognised in 2020.
Furthermore, if that study is successful it is anticipated that an
additional follow-on larger pivotal challenge study will commence
end Q4 2020, delivering significant further revenue which is
expected to be a minimum of GBP7m. This contract is significant as
it the first that utilises the complementary in-house CRO services
of both hVIVO and another of the Company's subsidiaries, Venn Life
Sciences, following the completion of the Company's merger with
hVIVO in late January and demonstrates the Company effectively
converting its pipeline.
Cathal Friel, Executive Chairman of Open Orphan, commented:
"This is an important milestone in the development and evolution
of Open Orphan and particularly the Company's subsidiary hVIVO
which is based in London, UK. We are very happy to be able to try
and assist in the battle against Covid-19. Our hVIVO scientists and
virologists, and especially hVIVO's founder and the now Chairman of
our Scientific Advisory Board Prof John Oxford, have a long history
and experience of successfully developing challenge studies.
This development also reinforces the strength of hVIVO's
reputation as a world leader in providing services to global
vaccine and anti-viral production companies and is another example
of the growth potential for Open Orphan. A considerable amount of
the work around this project has already been carried out and the
project takes advantage of the significant knowledge and experience
gained from hVIVO's previous challenge virus manufacturing
campaigns. We are delighted to be working with Mike Wang of the
international law firm King & Wood Mallesons who is working
with us to secure funders for this project from his network of
Chinese pharmaceutical and life science companies. "
Professor John Oxford, Chairman of Open Orphan's Scientific
Advisory Board, commented:
"After almost 5 years' of absence from hVIVO, I'm delighted to
be more involved again and particularly to be back involved as
Chairman of the Scientific Advisory Board. Over the years, I have
had extensive experience in dealing with novel and threatening
viruses and in 2009 I was the first person, in conjunction with the
hVIVO laboratory, to get permission from the government to bring
the SARS virus into the country in order to analyse it as part of
seeking a solution to the outbreak.
A couple of years ago, the hVIVO Scientific team started a
project to potentially develop a Coronavirus challenge study model
but after a certain amount of work and effort they suspended this
project because they didn't see sufficient market demand for a
Coronavirus challenge study model. However, in recent weeks, the
hVIVO scientific team led by their Chief Scientist Andrew Catchpole
have reopened their Coronavirus challenge study project and work
files. Given the unfortunate circumstances of Covid-19 now
spreading around the world they and I felt that there was an
obligation on us to reactivate the project and to do our best to
now swiftly and effectively make a Coronavirus challenge study
model available to the market as soon as possible.
I'm looking forward to working with the team in the days and
weeks ahead to do our best to make the world's first Coronavirus
challenge study model available as soon as possible."
For further information please contact
+353 (0)1 644
Open Orphan plc 0007
Cathal Friel, Executive Chairman +44 (0)20 7347
Trevor Phillips, Chief Executive Officer 5350
Arden Partners plc (Nominated Adviser and
Joint Broker) +44 (0)20 7614
John Llewellyn-Lloyd / Benjamin Cryer 5900
Davy (Euronext Growth Adviser and Joint
Broker) +353 (0)1 679
Anthony Farrell 6363
Camarco (Financial PR)
+44 (0)20 3757
Tom Huddart / Daniel Sherwen 4980
Notes to Editors:
Open Orphan is a rapidly growing specialist CRO pharmaceutical
services company which has a focus on orphan drugs and is a world
leader in the provision of virology and vaccine challenge study
services and viral laboratory services. It has Europe's only
24-bedroom quarantine clinic with onsite virology lab in London.
hVIVO supports product development for customers developing
antivirals, vaccines and respiratory therapeutics, all particularly
relevant and topical in the environment of heightened awareness of
the Coronavirus in 2020. The company also 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. No other company
in the world has such a portfolio, with only two competitors
globally having 1 challenge study model each.
Open Orphan comprises of two commercial specialist CRO services
businesses (Venn and hVIVO) and is developing an early stage orphan
drug genomics data platform business. This platform captures
valuable genetic data from patient populations with specific
diseases with designated orphan drug status and incorporating AI
tools. 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, as an integrated drug
development consultancy, offers CMC (c hemistry, 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.
About Coronavirus
Coronaviruses are a family of viruses that can lead to
respiratory illness, including Middle East Respiratory Syndrome
(MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV).
Coronaviruses are transmitted between animals and people and can
evolve into strains not previously identified in humans. On January
7, 2020, a novel coronavirus (2019-nCoV) was identified as the
cause of pneumonia cases in Wuhan City, Hubei Province of China,
and additional cases have been found in a growing number of
countries.(1,2)
(1) "Coronavirus." World Health Organization,
https://www.who.int/health-topics/coronavirus.
(2) "2019 Novel Coronavirus, Wuhan, China." Centers for Disease
Control and Prevention,
https://www.cdc.gov/coronavirus/2019-nCoV/index.html.
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END
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