REG - hVIVO PLC - Omicron human challenge model update

hVIVOAnnouncement

16/03/2023 07:00

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RNS Number : 1389T  hVIVO PLC  16 March 2023

 

hVIVO plc

("hVIVO" or the "Company")

 

Omicron human challenge model update

 

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 its Omicron human challenge agent has been
successfully manufactured.

 

Subject to the successful completion of the characterisation study and receipt
of relevant regulatory approvals, this has expanded the Company's unique
portfolio to 11 human challenge models to test a broad range of infectious and
respiratory disease products. hVIVO actively offers Omicron human challenge
trials as part of its service offering and is currently in discussions with a
number of existing and potential customers.

 

As announced on 30 June 2022, the model was developed with Vaxart Inc.
(https://vaxart.com/) ("Vaxart"), (NASDAQ: VXRT) with the intent to conduct a
subsequent Omicron human challenge study to test the efficacy of Vaxart's oral
vaccine candidate. The Company notes the announcement from Vaxart
(https://investors.vaxart.com/news-releases/news-release-details/vaxart-provides-business-update-and-full-year-2022-financial)
and its decision to postpone further clinical trials in its COVID-19
programme, including the challenge study, as they focus upon the development
of an oral pan-betacoronavirus vaccine, which may provide improved protection
against SARS-CoV-2 as the virus continues to mutate and protection against
other types of betacoronaviruses.

 

The Vaxart challenge study was not included in the Company's order book and
its postponement will have no impact on hVIVO's 2023 financial guidance. As at
31 December 2022 the Company's orderbook was £76m, with over 95% of
forecasted revenue for 2023 contracted.

 

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 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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