REG - hVIVO PLC - £2.5m contract for Omicron characterisation study

hVIVOAnnouncement

03/06/2024 07:00

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RNS Number : 7274Q  hVIVO PLC  03 June 2024

hVIVO plc

("hVIVO", the "Company" or the "Group")

 

£2.5m Contract for Omicron characterisation study

 

Highlights

 •    Characterisation study to establish world's first Omicron BA.5 challenge model
 •    Study to utilise hVIVO's new state-of-the-art containment level 3 (CL3)
      quarantine facilities in Canary Wharf
 •    FluCamp to recruit healthy 18-30 year old seropositive volunteers who have
      previously completed a course of COVID-19 vaccination
 •    New quarantine unit in Canary Wharf facilitates the expansion of hVIVO's world
      leading portfolio of human challenge models

 

hVIVO plc (AIM & Euronext: HVO), a fast 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 £2.5m contract with a mid-sized pharmaceutical company
to initiate an Omicron characterisation study (the "Study"). The manufacture
of hVIVO's Omicron BA.5 challenge agent was successfully completed in 2023.

 

The Study aims to identify a dose of hVIVO's Omicron BA.5 challenge agent that
establishes a safe, measurable and reproducible disease in healthy volunteers
with sufficiently high infection rates to then be able to use the model to
test the efficacy of antivirals and vaccines in the future. The Company's
dedicated volunteer recruitment arm, FluCamp (https://flucamp.com/) , will
recruit healthy volunteers aged 18-30 years who have previously received a
full course of a licenced COVID-19 vaccine. Characterisation studies offer
numerous benefits to biopharma clients, including insights into specific
pathogens that are more precise, actionable, and relevant to support and
refine vaccine or antiviral development. They also provide the necessary data
from which to design subsequent antiviral or vaccine efficacy testing studies.

 

The Study is expected to commence in Q4 2024, with the majority of revenue
recognised in 2025, and will take place at the Company's new CL3 quarantine
facility at Canary Wharf. hVIVO's facility has been specifically designed to
meet the highest hospital isolation suite standards suitable for CL3 pathogens
and is equipped with advanced safety features including physical containment
barriers, controlled ventilation systems with negative pressure and HEPA
filtration, and comprehensive waste management protocols. This is the first
COVID-related work that hVIVO will be undertaking since the manufacture of the
Omicron BA.5 challenge agent.

 

Dependent on the successful completion of the characterisation study and
receipt of relevant regulatory approvals, the Company expects to conduct
multiple Omicron human challenge trials to test the efficacy of medical
products from mid-2025. hVIVO successfully conducted the world's first
SARS-CoV-2 characterisation study, using the original COVID-19 strain in 2021,
with data showing that SARS-CoV-2 human challenge studies are safe in healthy
young adults.

 

Yamin 'Mo' Khan, Chief Executive Officer of hVIVO, said: "One of our key goals
at hVIVO is to further diversify our challenge trial offerings. The
establishment of a COVID challenge model is a key step to penetrating a new
and expanding market, especially with regards to mucosal and multi-valent
COVID vaccine development. This study will take place at our new CL3
quarantine facility in Canary Wharf, which will open shortly. The new site,
which was largely funded by a number of key clients, is the largest human
challenge trial quarantine clinic in the world and is highly specialised in
its design to facilitate the safe conduct of challenge studies. Securing this
contract further validates the move to our new facilities and the new
opportunities it brings for CL3 category projects."

 

Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: "We are excited
to begin work on characterising our Omicron challenge agent, which has been
made possible by our new CL3 facilities in Canary Wharf. We have leading
expertise in characterising SARS-CoV-2 challenge agents, having successfully
conducted the world's first COVID-19 characterisation study. The client
funding towards this study demonstrates the strong interest and growing
pipeline in this indication due to the continued risk that COVID-19, and
particularly the Omicron strain, poses to global health and ongoing need for
improved vaccines and treatments."

 

For further information please contact:

 

 hVIVO plc                                       +44 (0) 20 7756 1300
 Yamin 'Mo' Khan, Chief Executive Officer

 Stephen Pinkerton, Chief Financial Officer

 Cavendish Capital Markets Limited (Nominated Adviser and Joint Broker)                  +44 (0) 20 7220 0500
 Geoff Nash, Charlie Beeson, Nigel Birks, Harriet Ward

 Peel Hunt LLP (Joint Broker)                                        +44 (0)20 7418 8900
 James Steel, Dr Christopher Golden

 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 (http://www.hvivo.com/)  (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 Group has
world class challenge agent manufacturing capabilities, 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 trials in London with a new 50 quarantine bedroom,
state-of-the-art facilities opening in Canary Wharf in 2024, with highly
specialised on-site virology and immunology laboratories, and an outpatient
unit. To recruit volunteers / patients for its studies, the Group leverages
its unique clinical trial recruitment capability via its FluCamp
(http://www.flucamp.com/)  volunteer screening facilities in London and
Manchester.

 

About Omicron

 

Omicron is a variant of SARS-CoV-2 that was first reported to the World Health
Organization in November 2021 and is characterised by its heightened
transmissibility compared to previous variants. It is associated with a range
of symptoms similar to previous variants, such as fever, cough, and fatigue,
with many cases reporting milder symptoms.

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