REG - hVIVO PLC - hMPV human challenge model

hVIVOAnnouncement

28/06/2023 07:00

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RNS Number : 1072E  hVIVO PLC  28 June 2023

hVIVO plc

("hVIVO" or the "Company")

 

hVIVO to develop human metapneumovirus (hMPV) challenge model

First client of the new hMPV model secured

 

hVIVO plc (AIM & Euronext: HVO), (formerly Open Orphan plc) a rapidly
growing specialist contract research organisation and world leader in testing
infectious and respiratory disease products using human challenge clinical
trials, is developing a human metapneumovirus (hMPV) challenge model.  hVIVO
has signed an agreement with a North American biopharmaceutical company to
manufacture a hMPV virus and conduct a characterisation study, with the intent
to conduct a subsequent hMPV challenge trial in 2024 to test the efficacy of
its vaccine candidate.

 

hVIVO will commence Good Manufacturing Practice (GMP) compliant virus
manufacturing activities immediately and this is expected to complete in H1
2024. The Company will then conduct a characterisation study to identify a
safe and infectious dose of wild-type hMPV in up to 36 healthy adult
volunteers. Dependent on the successful completion of the characterisation
study and receipt of relevant regulatory approvals, the Company expects to
conduct hMPV challenge trials from H2 2024. The majority of the revenue from
this end-to-end human challenge service will be recognised in 2024.

 

The client intends to utilise the efficacy data from the challenge study to
define the endpoints for its hMPV vaccine candidate's clinical development
programme, as well as providing a greater understanding of virus progression,
aiding dosing decisions and confirming previous animal study results. This
will allow the client to streamline future trials and make critical go/no-go
decisions more quickly, therefore accelerating the development of the vaccine
candidate.

 

hMPV is a common virus that causes an upper respiratory infection, similar to
the common cold. Symptoms include cough, fever, nasal congestion, and
shortness of breath. Most people have mild cases of hMPV, but severe cases can
result in bronchiolitis, bronchitis and pneumonia. hMPV is associated with
approximately 20% of respiratory tract infections in children worldwide(1). Up
to 16% of the children infected with hMPV develop more severe symptoms(2),
with over 16,000 deaths worldwide in children under the age of five each
year.(3) Despite its prevalence and potential severity, there are currently no
vaccines or antivirals approved to treat hMPV.(4)

 

Yamin 'Mo' Khan, Chief Executive Officer of hVIVO, said: "We are delighted to
be developing the industry's first commercial hMPV human challenge model. The
continued expansion of our challenge model portfolio aligns with our mission
to deliver today's healthcare by empowering tomorrow's innovation. We hope to
help our client to bring their treatment to patients faster through the
utilisation of a new unique human challenge model. We will continue to expand
our library of challenge models and provide a mechanism for our customers to
expedite their drug development."

 

Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: "hVIVO's unique
expertise and world leading capabilities enables us to provide our clients
with a full human challenge service offering, including the development of
bespoke challenge models. As demonstrated with RSV, hVIVO can also play a
vital role in speeding up drug development for hMPV, which currently has no
approved vaccine or antiviral treatment."

 

(1)
https://www.sciencedirect.com/topics/immunology-and-microbiology/human-metapneumovirus
(https://www.sciencedirect.com/topics/immunology-and-microbiology/human-metapneumovirus)

(2) Howard LM, et al. 2021

(3) Wang X, et al. 2021

(4) CDC

 

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 (mailto: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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