TIDMORPH
Open Orphan PLC
12 May 2022
Open Orphan plc
("Open Orphan" or the "Company")
Key considerations document for developing and manufacturing
challenge agents published
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, notes a key considerations document for developing
and manufacturing challenge agents published in the Wellcome Open
Research Journal co-authored by Alex Mann, Senior Director of
Clinical Research of hVIVO and the project lead , a subsidiary of
Open Orphan plc, titled 'Considerations on the Principles of
Development and Manufacturing Qualities of Challenge Agents For Use
In Human Infection Models'.
The project was funded by the Wellcome Trust and HIC-Vac, an
international network of researchers who are developing human
infection challenge (HIC) studies to accelerate the development of
vaccines, based at Imperial College London. The considerations
document was prepared by an hVIVO led consortium , involving
engagement with global experts in the human challenge field and
manufacturing. It outlines the key aspects of the development,
characterisation and manufacture of infectious challenge agents.
The aim of the document is to promote volunteer safety whilst
maximising access to challenge agents and challenge models in
low-income or middle-income countries (LMICs) and academic
institutions globally.
It is hoped that these considerations will be used across high-,
middle- and low-income countries for the safe production of
challenge agents by trained personnel with appropriate facilities,
quality control measures and other best practices.
The increase in human challenge studies being established in
LMICs and the need for challenge agents to reflect naturally
occurring and epidemiologically relevant pathogen strains means
there is an increased likelihood that they will be manufactured in
conditions where full Good Manufacturing Practice ("GMP") is not
possible. This document fills the previous gap of clear guidance on
the minimum requirements for high-quality and safe manufacture
outside of GMP facilities.
Challenge agents are the viruses, parasites, bacteria used in
human challenge trials that volunteers are purposely challenged
with. Depending on the design of the trial, the volunteers may or
may not be administered a trial drug candidate before or after
being exposed to the challenge agent to provide early proof of
concept, allowing the candidate to progress more quickly to phase
II or phase III trials.
Wellcome Open Research provides all Wellcome researchers with a
place to rapidly publish any results they think are worth sharing.
All articles benefit from rapid publication, transparent peer
review and editorial guidance on making all source data openly
available.
Yamin Khan, Chief Executive Officer of Open Orphan, said: "As
the world leader in conducting human challenge studies I am
delighted that Open Orphan continues to play a key role in
democratising access to human challenge trials. This latest
document provides clear considerations for challenge agent
manufacturing, where previously a gap existed regarding the minimum
requirements for high-quality safe manufacture outside of GMP
facilities. Human challenge trials have clear advantages over
traditional clinical field trials, and their global adoption will
be vital to progressing the development of vaccines and
anti-infectives around the world."
Alex Mann, Project leader and Senior Director, Clinical Science
at hVIVO, said: "I was pleased to co-author the considerations
document and the associated summary publication in collaboration
with the Wellcome Trust and HIC-Vac, that recommends key aspects
for researchers to consider for challenge agent development and
manufacturing. In recent years, there has been an increase in human
challenge studies in low- or middle-income countries where GMP
facilities are not readily available. This document will support
the development, characterisation and manufacture of challenge
agents in these settings, while also maximising volunteer safety
and access to challenge agents and challenge models."
Shobana Balasingam, Research Lead in Infectious Disease
Prevention at Wellcome, said: "The guidance to manufacture safe and
effective challenge agents under GMP conditions differs globally
and is not always feasible, which can slow down vital research,
particularly in low- and middle-income countries where this
research is often most-needed. However, guidelines for
manufacturing outside of GMP facilities are not currently
available.
"As funders of global infectious disease research, Wellcome are
please to support this clear and practical document for developing
challenge agents where GMP is not possible. This guidance can
ensure the full potential of human infection studies around the
world, which provide crucial insight into infectious diseases,
helping to rapidly accelerate the development of vaccines."
An editorial will be published alongside the report:
'Considerations on the Principles of Development and Manufacturing
Qualities of Challenge Agents For Use In Human Infection Models' by
Shobana Balasingam, Sarah Meillon(,) Cecilia Chui, Alex Mann,
Carine La, Charlie Weller, Debbie King and Emma Smith. Available in
Wellcome Open Research. DOI:
https://doi.org/10.12688/wellcomeopenres.17869.1
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 +353 (0) 1 644 0007
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 and is developing a
number of new models, such as malaria and COVID-19, 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 Wellcome
Wellcome supports science to solve the urgent health challenges
facing everyone. We support discovery research into life, health
and wellbeing, and we're taking on three worldwide health
challenges: mental health, global heating and infectious
diseases.
This information is provided by Reach, the non-regulatory press
release distribution service of RNS, part of the London Stock
Exchange. 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.
Reach is a non-regulatory news service. By using this service an
issuer is confirming that the information contained within this
announcement is of a non-regulatory nature. Reach announcements are
identified with an orange label and the word "Reach" in the source
column of the News Explorer pages of London Stock Exchange's
website so that they are distinguished from the RNS UK regulatory
service. Other vendors subscribing for Reach press releases may use
a different method to distinguish Reach announcements from UK
regulatory news.
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
NRAEFLFFLELLBBZ
(END) Dow Jones Newswires
May 12, 2022 02:02 ET (06:02 GMT)
Venn Life Sciences (LSE:VENN)
Historical Stock Chart
From Jun 2024 to Jul 2024
Venn Life Sciences (LSE:VENN)
Historical Stock Chart
From Jul 2023 to Jul 2024