REG - hVIVO PLC - £5.2m RSV contract and Notice of Trading update

hVIVOAnnouncement

04/01/2023 07:00

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RNS Number : 5774L  hVIVO PLC  04 January 2023

hVIVO plc

("hVIVO" or the "Company")

 

£5.2m 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 £5.2m 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 (http://www.flucamp.com/) .

 

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
(https://www.cnbc.com/2022/11/18/biden-asked-to-declare-emergency-over-rsv-flu-kids-hospitalizations.html)

 

 

 

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 Marriage /         +44 (0) 7796 794 663 / +44 (0) 7867 984 082 /

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
(https://eur05.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.flucamp.com%2F&data=05%7C01%7CCarol.Dalton%40openorphan.com%7Cfb9f1a50aaa9492d81ed08da875cca71%7C131abc777e104bbd90170559abc5d601%7C1%7C0%7C637971129881295595%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=fQdtQTHu9Bo70yRgWcZW5liNTXPYiWl9YayUA01E%2FlA%3D&reserved=0)
 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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