TIDMHVO
RNS Number : 1072E
hVIVO PLC
28 June 2023
hVIVO plc
("hVIVO" or the "Company")
hVIVO to develop human metapneumovirus (hMPV) challenge
model
First client of the new hMPV model secured
hVIVO plc (AIM & Euronext: HVO) , (formerly Open Orphan plc)
a rapidly growing specialist contract research organisation and
world leader in testing infectious and respiratory disease products
using human challenge clinical trials, is developing a human
metapneumovirus (hMPV) challenge model. hVIVO has signed an
agreement with a North American biopharmaceutical company to
manufacture a hMPV virus and conduct a characterisation study, with
the intent to conduct a subsequent hMPV challenge trial in 2024 to
test the efficacy of its vaccine candidate.
hVIVO will commence Good Manufacturing Practice (GMP) compliant
virus manufacturing activities immediately and this is expected to
complete in H1 2024. The Company will then conduct a
characterisation study to identify a safe and infectious dose of
wild-type hMPV in up to 36 healthy adult volunteers. Dependent on
the successful completion of the characterisation study and receipt
of relevant regulatory approvals, the Company expects to conduct
hMPV challenge trials from H2 2024. The majority of the revenue
from this end-to-end human challenge service will be recognised in
2024.
The client intends to utilise the efficacy data from the
challenge study to define the endpoints for its hMPV vaccine
candidate's clinical development programme, as well as providing a
greater understanding of virus progression, aiding dosing decisions
and confirming previous animal study results. This will allow the
client to streamline future trials and make critical go/no-go
decisions more quickly, therefore accelerating the development of
the vaccine candidate.
hMPV is a common virus that causes an upper respiratory
infection, similar to the common cold. Symptoms include cough,
fever, nasal congestion, and shortness of breath. Most people have
mild cases of hMPV, but severe cases can result in bronchiolitis,
bronchitis and pneumonia. hMPV is associated with approximately 20%
of respiratory tract infections in children worldwide(1) . Up to
16% of the children infected with hMPV develop more severe
symptoms(2) , with over 16,000 deaths worldwide in children under
the age of five each year.(3) Despite its prevalence and potential
severity, there are currently no vaccines or antivirals approved to
treat hMPV.(4)
Yamin 'Mo' Khan, Chief Executive Officer of hVIVO, said: "We are
delighted to be developing the industry's first commercial hMPV
human challenge model. The continued expansion of our challenge
model portfolio aligns with our mission to deliver today's
healthcare by empowering tomorrow's innovation. We hope to help our
client to bring their treatment to patients faster through the
utilisation of a new unique human challenge model. We will continue
to expand our library of challenge models and provide a mechanism
for our customers to expedite their drug development."
Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said:
"hVIVO's unique expertise and world leading capabilities enables us
to provide our clients with a full human challenge service
offering, including the development of bespoke challenge models. As
demonstrated with RSV, hVIVO can also play a vital role in speeding
up drug development for hMPV, which currently has no approved
vaccine or antiviral treatment."
(1)
https://www.sciencedirect.com/topics/immunology-and-microbiology/human-metapneumovirus
(2) Howard LM, et al. 2021
(3) Wang X, et al. 2021
(4) CDC
Interested in becoming a volunteer?
hVIVO recruits 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:
hVIVO plc +44 (0) 20 7756 1300
Yamin 'Mo' Khan, Chief Executive
Officer
Stephen Pinkerton, Chief Financial
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, Charlie Beeson, Nigel Birks,
Harriet Ward (ECM)
Davy (Euronext Growth Adviser and Joint
Broker) +353 (0) 1 679 6363
Anthony Farrell, Niall Gilchrist
Walbrook PR (Financial PR & IR) +44 (0) 20 7933 8780 or hvivo@walbrookpr.com
Stephanie Cuthbert / Phillip +44 (0) 7796 794 663 / +44 (0) 7867 984
Marriage / 082 /
Louis Ashe-Jepson +44 (0) 7747 515 393
Notes to Editors
About hVIVO
hVIVO plc (ticker: HVO) (formerly Open Orphan plc) is a rapidly
growing specialist contract research organisation (CRO) and the
world leader in testing infectious and respiratory disease vaccines
and therapeutics using human challenge clinical trials. The Group
provides end-to-end early clinical development services to its
large, established and growing repeat client base, which includes
four of the top 10 largest global biopharma companies.
The Group's fast-growing services business includes a unique
portfolio of 11 human challenge models, with a number of new models
under development, to test a broad range of infectious and
respiratory disease products. The Company has world class challenge
agent manufacturing, specialist drug development and clinical
consultancy services via its Venn Life Sciences brand, and a lab
offering via its hLAB brand, which includes virology, immunology
biomarker and molecular testing. The Group offers additional
clinical field trial services such as patient recruitment and
clinical trial site services.
hVIVO 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
clinic in Plumbers Row. To recruit volunteers / patients for its
studies, the Company leverages its unique clinical trial
recruitment capability via its FluCamp volunteer screening
facilities in London and Manchester.
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END
MSCQDLFLXQLXBBV
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June 28, 2023 02:00 ET (06:00 GMT)
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