TIDMHVO
RNS Number : 5774L
hVIVO PLC
04 January 2023
hVIVO plc
("hVIVO" or the "Company")
GBP5.2m RSV human challenge study contract with global
biotechnology company in Asia Pacific
and Notice of Trading Update
A new client from a new regional market
hVIVO plc (AIM & Euronext: HVO) (formerly Open Orphan plc),
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 it
has signed a GBP5.2m contract with a global biotechnology company
headquartered in Asia Pacific to test their respiratory syncytial
virus ("RSV") vaccine candidate, using hVIVO's established RSV
Human Challenge Study Model. The Company also announces that it
will provide a trading update for the year ended 31 December 2022
on 25 January 2023.
The Phase 2a double-blinded placebo-controlled human challenge
trial will take place at the Company's specialist quarantine
facilities in London and will evaluate the safety, immunogenicity
and efficacy of the client's vaccine candidate against RSV
infection. The study is expected to commence in H2 2023, with the
revenue being recognised across 2023 and 2024. As part of the
study, hVIVO will recruit healthy volunteers via the Company's
dedicated volunteer recruitment arm, FluCamp .
This is the first human challenge trial contract that hVIVO has
signed with a client in the Asia-Pacific ("APAC") region in over a
decade, and is a growth area for the Company as it seeks to further
diversify its client base and orderbook. The contract also further
highlights the growing demand for challenge trials from global
biopharmaceutical companies as they seek to gain cost-effective
efficacy data to de-risk their development programmes and enhance
their candidate's value before commencing later-stage field
studies.
hVIVO has three decades of experience and expertise in safely
conducting challenge studies across a range of respiratory viruses,
including various strains of influenza, respiratory syncytial virus
(RSV) and human rhinovirus (HRV - common cold virus), and asthma,
as well as malaria.
Yamin 'Mo' Khan, Chief Executive Officer of hVIVO, said: "I am
delighted to have signed this contract with a biotechnology company
headquartered in Asia Pacific to test its RSV vaccine candidate,
which is our first contract signed in the region in over a decade.
APAC has been identified as a key growth region for the Company,
and this contract is an encouraging indicator that our strategy
there is bearing fruit. I am optimistic that more biopharma
companies in the APAC region will increasingly recognise both the
value of human challenge trials, and hVIVO's reputation as the
'go-to' partner in the market.
"This award further strengthens our revenue visibility into 2024
and gives weight to the fact that we have a strong and sustainable
growth model. The team has worked hard to achieve record numbers in
2022, and this award is the perfect start to 2023."
Dr Andrew Catchpole, Chief Scientific Officer of hVIVO said:
"Although RSV has a low chance of causing serious illness in
healthy adults, it can be highly virulent for children and the
elderly. The disease has caused particular strain on paediatric
health this winter in the US and Europe, with reports suggesting
newborns are being hospitalised in the US at seven times the rate
observed in 2018, the last non-COVID-19 winter season(1) . This has
reinforced the global need for innovative vaccines and antivirals;
the hVIVO RSV Human Challenge Model can play a critical role in
bringing these treatments to market more quickly."
1. CNBC News, 18 November 2022: Children's hospitals call on
Biden to declare emergency in response to 'unprecedented' RSV
surge
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
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 10+ human challenge models to test a broad range of
infectious and respiratory disease products, 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 capacity via its FluCamp volunteer screening facilities
in London and Manchester.
About RSV
RSV is the main cause of childhood lower respiratory infections
and is responsible for a significant burden of disease in the
elderly and in adults with chronic medical problems, such as COPD.
Globally it affects an estimated 50-million people annually,
leading to 4 million hospitalisations and approximately 60,000
in-hospital deaths in children younger than 5 years. There is a
lack of understanding and insight into RSV disease, especially in
adult groups, despite its considerable impact on society and its
high degree of infectivity.
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