TIDMORPH
RNS Number : 7216Q
Open Orphan PLC
30 June 2022
Open Orphan plc
("Open Orphan" or the "Company")
hVIVO to develop the world's first Omicron human challenge
model
Vaxart becomes the first client of the programme to test its
oral COVID-19 vaccine candidate
Open Orphan plc (AIM: ORPH), 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 hVIVO , a subsidiary of Open
Orphan, is developing the world's first Omicron human challenge
model. hVIVO has signed an agreement with Vaxart Inc. ("Vaxart"),
(NASDAQ: VXRT) to develop the model with the intent to conduct a
subsequent Omicron human challenge study in 2023 to test the
efficacy of Vaxart's oral vaccine candidate, VXA-CoV2-1.
To develop the model, hVIVO will manufacture a new SARS-CoV-2
(COVID-19) challenge agent based on the Omicron variant. The Good
Manufacturing Practice ("GMP") compliant virus manufacturing
activities will commence immediately and are expected to complete
by Q4 2022. Following manufacture of the challenge agent, the
Company intends to conduct a characterisation study. Subject to the
successful completion of the characterisation study and receipt of
relevant regulatory approvals, hVIVO expects to conduct Omicron
human challenge studies in 2023.
The characterisation study will establish a dose of the Omicron
challenge agent that will cause a safe and reliable infection in
healthy volunteers. The study will enrol healthy male and female
volunteers who have previously been vaccinated against or infected
with SARS-CoV-2, with no known risk factors for severe COVID-19 and
low levels of serum neutralising antibodies (and therefore still
likely to become infected following inoculation).
hVIVO has two decades of experience and expertise in challenge
agent manufacture and clinical characterisation across a range of
respiratory viruses including various strains of influenza,
respiratory syncytial virus (RSV), human rhinovirus (hRV - common
cold virus), as well as the initial circulating SARS-CoV-2 virus
and variants which have since emerged. hVIVO leads the Challenge
Agent Manufacture Consortium, which has developed international
standards that pertain to challenge agent manufacture and storage,
to ensure safety, quality and consistency.
Yamin Khan, Chief Executive Officer of Open Orphan, said: "With
our leading end-to-end human challenge expertise, we are delighted
to be developing the world's first Omicron human challenge model
and to welcome Vaxart as the first client of this programme.
"hVIVO's fight against the pandemic continues with the
development of this new challenge agent. The benefits to Vaxart are
immense, and we have already been contacted by a number of
biopharma companies looking to test the efficacy of their products
using this challenge virus. I have no doubt that the successful
completion of the world's first COVID-19 characterisation, which
was published in Nature Medicine earlier this year, has given our
customers the confidence to move forward with the less severe yet
more infective Omicron challenge model."
Dr. James Cummings, Chief Medical Officer of Vaxart, said: "A
human challenge study of our oral tablet COVID-19 vaccine candidate
against the Omicron variant of SARS-CoV-2 is the most rapid and
direct way to assess the efficacy of this candidate against a
highly prevalent viral strain.
"hVIVO has pioneered COVID-19 characterization and the Omicron
human challenge model, and the use of this model in our planned
Phase II human challenge trial will rapidly generate robust,
controlled data on the ability of our COVID-19 vaccine candidate to
prevent infection and the development of symptomatic disease, as
well as its effect on viral shedding, which plays a critical role
in the spread of infection from one person to another. The results
of this study will inform the next steps in the development of our
COVID-19 vaccine candidate, which has the potential to transform
personal and public health approaches to controlling the global
pandemic."
Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said:
"The team and I at hVIVO are excited to begin work to manufacture
an Omicron challenge agent, the follow-on characterisation, and
future human challenge trials. We have unparalleled expertise in
SARS-CoV-2 challenge agent manufacturing, having completed work on
both the original Wuhan strain and the subsequent Delta variant, in
addition to our prior experience in successfully conducting the
world's first COVID-19 characterisation study, and our decades of
experience in conducting human challenge trials. We are delighted
to be working with Vaxart on this programme and look forward to the
opportunity to subsequently test the efficacy of their exciting
novel vaccine."
Interested in becoming a volunteer?
hVIVO recruits many of its volunteers for its challenge study
clinical trials through its dedicated volunteer recruitment
website, 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:
Open Orphan plc +44 (0) 20 7756 1300
Yamin Khan, Chief Executive 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 / James Thompson / Richard
Chambers
Davy (Euronext Growth Adviser and
Joint Broker) +353 (0) 1 679 6363
Anthony Farrell
Walbrook PR (Financial PR & IR) +44 (0)20 7933 8780 or openorphan@walbrookpr.com
Paul McManus / Sam Allen / Louis +44 (0)7980 541 893 / +44 (0) 7502 558
Ashe-Jepson 258 /
+44 (0)7747 515393
Notes to Editors
Open Orphan plc
Open Orphan plc (London and Euronext: ORPH) is a rapidly growing
contract research company that is a world leader in testing
infectious and respiratory disease products using human challenge
clinical trials. The Company provides services to Big Pharma,
biotech, and government/public health organisations.
The Company has a leading portfolio of human challenge study
models for infectious and respiratory diseases, including the
recently established COVID-19 model, and is developing a number of
new models, such as Malaria, to address the dramatic growth of the
global infectious disease market. The Paris and Breda offices have
over 25 years of experience providing drug development services
such as biometry, data management, statistics CMC, PK and medical
writing to third party clients as well as supporting the
London-based challenge studies.
Open Orphan 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 newly opened clinic in Plumbers Row. To recruit volunteers
/ patients for its studies, the Company leverages its unique
clinical trial recruitment capacity via its FluCamp volunteer
screening facilities in London and Manchester. The newly opened
facilities have expanded the scope of the business to enable the
offering of Phase I and Phase II vaccine field trials, PK studies,
bridging studies, and patient trials as part of large international
multi-centre studies.
Building upon its many years of challenge studies and virology
research, the Company is developing an in-depth database of
infectious disease progression data. Based on the Company's Disease
in Motion(R) platform, this unique dataset includes clinical,
immunological, virological, and digital (wearable) biomarkers.
About Vaxart
Vaxart is a clinical-stage biotechnology company developing a
range of oral recombinant vaccines based on its proprietary
delivery platform. Vaxart vaccines are designed to be administered
using tablets that can be stored and shipped without refrigeration
and eliminate the risk of needle-stick injury. Vaxart believes that
its proprietary tablet vaccine delivery platform is suitable to
deliver recombinant vaccines, positioning the company to develop
oral versions of currently marketed vaccines and to design
recombinant vaccines for new indications. Vaxart's development
programs currently include tablet vaccines designed to protect
against coronavirus, norovirus, seasonal influenza, and respiratory
syncytial virus (RSV), as well as a therapeutic vaccine for human
papillomavirus (HPV), Vaxart's first immune-oncology indication.
Vaxart has filed broad domestic and international patent
applications covering its proprietary technology and creations for
oral vaccination using adenovirus and TLR3 agonists.
About Human Challenge Trials
During human challenge trials, healthy volunteers are
administered a pathogenic or virulent strain of a challenge agent
(which can be a virus, bacteria, or a parasite), in a safe and
controlled quarantine setting to assess the efficacy of vaccines or
treatments.
About Omicron
The Omicron variant of SARS-CoV-2, similarly to previous
variants, is comprised of several lineages and sublineages. Since
its discovery, it has spread more rapidly than earlier variants of
the virus yet is generally considered to cause less severe disease
than infection with prior variants, such as Delta.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
RNS may use your IP address to confirm compliance with the terms
and conditions, to analyse how you engage with the information
contained in this communication, and to share such analysis on an
anonymised basis with others as part of our commercial services.
For further information about how RNS and the London Stock Exchange
use the personal data you provide us, please see our Privacy
Policy.
END
MSCFLFFTRIIAFIF
(END) Dow Jones Newswires
June 30, 2022 02:00 ET (06:00 GMT)
Venn Life Sciences (LSE:VENN)
Historical Stock Chart
From Apr 2024 to May 2024
Venn Life Sciences (LSE:VENN)
Historical Stock Chart
From May 2023 to May 2024