REG - hVIVO PLC - Flu B challenge model

hVIVOAnnouncement

25/07/2023 07:00

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RNS Number : 0199H  hVIVO PLC  25 July 2023

hVIVO plc

("hVIVO" or the "Company")

 

£13.1m 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 £13.1m 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 (http://www.flucamp.com) 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
(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
(http://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 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 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
(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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