REG - hVIVO PLC - £6.8m RSV human challenge contract signed

hVIVOAnnouncement

06/02/2023 07:00

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RNS Number : 9321O  hVIVO PLC  06 February 2023

hVIVO plc

("hVIVO" or the "Company")

 

£6.8m RSV human challenge contract signed

Second contract with an APAC client in 2023

 

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 £6.8m contract with a leading
pharmaceutical company based in Asia Pacific ("APAC"), to test its respiratory
syncytial virus ("RSV") antiviral drug candidate, using the hVIVO RSV Human
Challenge Study Model.

 

The Phase 2a double-blinded placebo-controlled human challenge trial will
take place at the Company's specialist quarantine facilities
in Whitechapel and will evaluate the efficacy profile of the antiviral
against RSV infection in healthy volunteers. The study is expected to
commence in H1 2024, with revenue mostly recognised in 2024. As part of the
study, hVIVO will recruit healthy volunteers via the Company's dedicated
volunteer recruitment arm, FluCamp (http://www.flucamp.com/) .

 

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 four million hospitalisations and
approximately 60,000 in-hospital deaths in children younger than five
years.(1) hVIVO has inoculated over 1,600 healthy volunteers across 28 RSV
challenge trials to date and the challenge trial data has already expedited
the development of several RSV vaccines for a number of pharmaceutical
companies.

 

This is the second human challenge trial contract that hVIVO has signed with
an Asia-Pacific client in 2023 following the identification of this region as
a key growth area for the Company. The strength of data generated from hVIVO's
human challenge trials is resulting in a growing demand from global
biopharmaceutical companies, as they seek to de-risk their development
programmes ahead of later stage field studies.

 

Yamin 'Mo' Khan, Chief Executive Officer of hVIVO, said: "We are delighted
to be working with this client on their important RSV programme. RSV has been
a particular blight on humanity with no effective vaccine against this virus
in over 60 years of R&D. Our RSV challenge trial model is a tried and
tested model that has been used to expedite the development of several RSV
vaccine candidates, and we expect that at least one of the vaccines we have
worked on will reach patients this year. This new client will benefit from our
experience and expertise to impact their drug development plans.

 

"For hVIVO, it is highly encouraging to see our global client list continue to
grow and our orderbook further diversify with our second significant contract
with an APAC client. One of our goals for 2023 is to attract more customers
from the APAC region, and we have already seen this come to fruition with two
contracts. It is a great start to the year and builds our pipeline for 2024.
We expect to continue this strong momentum in the APAC region, and the rest of
the world, as the growing number of biopharma companies recognise the strong
value of human challenge models."

 

(1) Shi, T. et al. Global, regional, and national disease burden estimates of
acute lower respiratory infections due to respiratory syncytial virus in young
children in 2015: a systematic review and modelling study. The Lancet 390,
946-958 (2017).

 

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

 

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 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.

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