TIDMHVO
RNS Number : 0199H
hVIVO PLC
25 July 2023
hVIVO plc
("hVIVO" or the "Company")
GBP13.1m contract with global pharmaceutical client to develop
an influenza B virus challenge model
hVIVO plc (AIM & Euronext: HVO) , the world leader in
testing infectious and respiratory disease products using human
challenge clinical trials, announces a GBP13.1m contract with an
existing top five global pharmaceutical client to develop an
Influenza B ("Flu B") human challenge model.
Highlights
-- Key prerequisite phase of manufacturing virus is complete
-- Characterisation trial due to commence in Q4 2023 following
completion of manufacturing process
-- Supplementary fee to ensure expedited delivery and guaranteed availability of beds
-- Potential for a future challenge trial pending a successful characterisation study
The contract scope includes the manufacture of an influenza B
challenge virus, a characterisation study, and a supplementary fee
to ensure sufficient capacity is available to complete the
characterisation trial in an expedited manner. The successful
manufacturing of the challenge virus is a prerequisite for the
characterisation trial revenue to be delivered, and with the Good
Manufacturing Practice (GMP) challenge agent manufacture now in its
final stages, the Company will be able to commence the
characterisation study in Q4 2023.
The characterisation study aims to identify a dose of influenza
B that elicits a safe and reproducible infection in healthy
volunteers recruited through the FluCamp platform. Subject to the
successful completion of the characterisation study and the receipt
of relevant regulatory approvals, the Company expects to conduct an
influenza B human challenge trial in H1 2024. Revenue from this
human challenge model development contract will be recognised
throughout 2023 and 2024.
hVIVO is proud to be the exclusive contract research
organisation offering this bespoke human challenge model
development services with unparalleled knowledge and expertise in
this field spanning back as far as the UK Common Cold Unit. Testing
medicines against specific virus strains offer numerous benefits to
biopharma clients including the certainty of testing efficacy
against specific and new strains of virus.
The Centers for Disease Control and Prevention reports that both
influenza A and B can have equally severe symptoms,(1) although
type B is less prevalent. Similar to type A, influenza B is also
highly contagious and can cause life-threatening complications in
severe cases. Unlike influenza A viruses, which are known to infect
a variety of different species and, therefore, have pandemic
potential, influenza B viruses typically only infect humans.
Influenza B causes seasonal epidemics and gradually evolves to
evade the immune system so, like influenza A viruses, the seasonal
vaccine component against influenza B virus needs to be updated
frequently to maximise protective efficacy.
Yamin 'Mo' Khan, Chief Executive Officer of hVIVO, said: "This
is the second bespoke human challenge model development contract
announced in as many months and continues the trend of large
contract wins for hVIVO. This existing top five global
pharmaceutical client will support the development of a new
influenza B challenge model to potentially test its vaccine
candidate, in turn furthering our industry leading position by
broadening our library of human challenge models. Importantly, the
contract also further diversifies our revenue pipeline across
challenge agents and provides further visibility of revenue into
2024."
Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said:
"hVIVO is the only commercial provider of human challenge trial
services that can offer human challenge model development services
to ensure that challenge models are available to meet the specific
needs of our customers. The creation of a Flu B challenge model
will potentially allow this top five global pharmaceutical client's
vaccine candidate to gain quick efficacy data against a type of
influenza which is near impossible to achieve via traditional field
trials. This unparalleled efficacy data is extremely valuable, as
it can open up new markets and strengthen product label claims,
significantly increasing the potential value of existing clinical
assets."
(1) https://www.healthline.com/health/influenza-b-symptoms
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
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