TIDMORPH
RNS Number : 4698N
Open Orphan PLC
01 June 2022
THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES
OF ARTICLE 7 OF THE UK VERSION OF THE MARKET ABUSE REGULATION (EU)
NO.596/2014, WHICH FORMS PART OF UK LAW BY VIRTUE OF THE EUROPEAN
UNION (WITHDRAWAL) ACT 2018 ("UK MAR").
Open Orphan plc
("Open Orphan" or the "Company")
GBP14.7m influenza contract signed
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
plc, has signed a GBP14.7m contract for an influenza
characterisation study and a follow on influenza human challenge
study with an existing top five global pharmaceutical client.
Revenue from the contract will be recognised across 2022 and
2023.
This follows a challenge virus manufacturing contract signed
with the same client, announced on 4 May 2022. Following completion
of the challenge agent manufacturing, the characterisation study
will identify a dose of the flu challenge agent that causes a safe
and reliable infection in healthy volunteers. The study, which is
sponsored by hVIVO, is expected to start in Q3 2022, subject to the
relevant regulatory approvals, and will enrol volunteers recruited
from the Company's clinical trial volunteer recruitment arm,
FluCamp .
As part of the study, hVIVO Labs will develop and validate
challenge agent specific assays for the new flu challenge agent to
US Food and Drug Administration (FDA), European Medicines Agency
(EMA) and International Council for Harmonisation of Technical
Requirements for Pharmaceuticals for Human Use (ICH) standards.
This includes quantitative polymerase chain reaction (qPCR) for
viral load determination, viral infectivity assay and serological
assays for antibody level determination.
Following completion of the characterisation study, hVIVO will
conduct a human challenge study, expected to commence in Q1 2023.
The study will enable the Company to determine the efficacy of a
number of different vaccine candidates for the reduction in
incidence of symptomatic flu infection and disease severity in
healthy volunteers. This will help select which of the candidates
to progress further into later stage clinical trials. The vaccine
study can be initiated, subject to receipt of the relevant
regulatory approvals, as soon as the Company completes the
infectivity and safety data review from the characterisation study
and establishes the best challenge agent dose for safe volunteer
inoculation.
Yamin 'Mo' Khan, Chief Executive Officer of Open Orphan, said:
"This is another important milestone for hVIVO in that, in addition
to the previously announced manufacture of a bespoke challenge
agent, we have now been contracted to conduct the characterisation
and the challenge studies with this big pharma customer. Moreover,
we will also be providing full recruitment and laboratory services.
This highlights hVIVO's unique full-service offering in running
complex human challenge studies. Our team has a long history of
manufacturing challenge agents and conducting human challenge
studies. In regard to challenge studies our experience is
unrivalled, our scientific expertise unmatched, and our operational
delivery in a class of its own."
Alex Mann, Senior Director of Clinical Science of hVIVO, Sponsor
Representative and Scientific Design Lead, commented: "This major
contract win solidifies hVIVO's position in the market in offering
the full spectrum of support to clients, from start to finish of
the vaccine and drug discovery process. Furthermore, the
development of challenge agent specific assays underlines the skill
and expertise of our experienced lab scientific team to validate
bespoke assays to international standards for use in good clinical
practice (GCP) clinical trials.
The threat of influenza has never been greater, with an
estimated one billion cases per year. Our continued work to support
our clients' vaccine and antiviral programme's will support the
quick, efficient and cost-effective development of these lifesaving
medicines."
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.
For further information please contact:
Open Orphan plc +44 (0) 20 7756 1300
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
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, including the
recently established COVID-19 model, and is developing a number of
new models, such as Malaria, 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.
About Flu
Influenza (flu) is a contagious respiratory illness caused by
influenza viruses that infect the nose, throat, and lungs. Seasonal
influenza causes significant morbidity and mortality each year and
a pandemic influenza continues to pose a worldwide threat.
Influenza is a serious global health threat with an estimated 1
billion cases per year, 3-5 million severe cases and 290,000 -
650,000 deaths per year. Healthy volunteer human challenge studies
of wild-type influenza play a major role in the development of
vaccines and therapeutics against influenza.
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