TIDMORPH
Open Orphan PLC
19 November 2020
REACH
19 November 2020
Open Orphan plc
("Open Orphan" or the "Company")
Collaboration Agreement with HIC-VAC and Wellcome Trust
Open Orphan, a rapidly growing specialist CRO pharmaceutical
services company which is the world leader in the testing of
vaccines and antivirals using human challenge clinical trials is
pleased to announce that its subsidiary hVIVO has been selected to
lead a consortium, on behalf of HIC-Vac, an international network
of researchers who are developing human infection challenge (HIC)
studies to accelerate the development of vaccines against
pathogens, and the Wellcome Trust, to generate regulatory style
guidelines on the manufacture of human challenge agents for
subsequent use in controlled human infection studies (CHIM).
Highlights:
-- This consortium aims to develop international standards that
pertain to challenge agent manufacture and storage, extending the
current general WHO guidelines relating to challenge studies.
-- The consortium intends to create guidance fulfilling Good
Manufacturing Practice (GMP) requirements to as much as is
practically possible without necessarily being GMP certified,
'GMP-like' guidance. This will allow flexibility to manufacture
challenge agents outside of GMP-certified premises, but with
guidance to ensure safety, quality and consistency are
maintained.
The guidance will be produced in consultation with a range of
researchers currently working with different challenge agents as
well as with input from regulatory experts and, where possible,
regulatory or advisory bodies (such as the WHO). There will also be
wider engagement beyond the core consortium members with the
specific intent of aiming to ensure its' full applicability to all
currently used challenge agents and its potential for wide adoption
globally by local regulatory bodies and non-governmental
institutions involved in the provision of guidance associated with
CHIM studies. Learn more about the consortium at
hvivo.com/aboutus/clinical-trial-consortium/
Cathal Friel, Executive Chairman of Open Orphan , said:
'We are proud to have been selected to work alongside HIC-Vac
and the Wellcome Trust to lead the consortium on this important and
much needed guideline. hVIVO is at the forefront of human challenge
studies and has world leading capabilities, this collaboration is
recognition of the work we do in the scientific community."
Andrew Catchpole, Chief Scientific Officer, hVIVO, said:
"We are delighted to be collaborating with the members of the
international consortium with specific input from low-to-Middle
income countries (LMIC's).
Today's announcement shows the continued commitment of the
infectious disease community in progressing designs and
capabilities for research into bacteria, parasites and
viruses."
Footnote
CHIM - controlled human infection studies are when a
well-characterised strain of an infectious agent is given to
carefully selected adult volunteers in order to better understand
human diseases, how they spread, and find new ways to prevent and
treat them. These studies play a vital role in helping to develop
vaccines for infectious diseases.
Good Manufacturing Practice (GMP) is a system for ensuring that
products are consistently produced and controlled according to
quality standards. It is designed to minimize the risks involved in
any pharmaceutical production that cannot be eliminated through
testing the final product.
For further information please contact
Open Orphan plc +353 (0)1 644 0007
Cathal Friel, Executive Chairman
Arden Partners plc (Nominated Adviser and +44 (0)20 7614
Joint Broker) 5900
John Llewellyn-Lloyd / Benjamin Cryer /
Dan Gee-Summons
+44 (0) 20 7220
finnCap plc (Joint Broker) 500
Geoff Nash / James Thompson / Richard Chambers
Davy (Euronext Growth Adviser and Joint
Broker) +353 (0)1 679 6363
Anthony Farrell
+44 (0)20 3757
Camarco (Financial PR) 4980
Tom Huddart / Hugo Liddy
Notes to Editors - Open Orphan:
Open Orphan is a rapidly growing niche CRO pharmaceutical
services company which is the world leader in the testing of
vaccines and antivirals through the use of human challenge clinical
trials. Conducted from Europe's only 24-bedroom quarantine clinic
with onsite virology providing individually isolated rooms and
connected to our specialist laboratory facility. hVIVO's challenge
studies require healthy volunteers to take part, volunteers are
recruited through FluCamp , learn more at www.FluCamp.com. The
hVIVO facility offers highly specialised virology and immunology
laboratory services to support pre-clinical and clinical
respiratory drug, antiviral, and vaccine discovery and development.
Reliable laboratory analysis underpinned by scientific expertise is
essential when processing and analysing clinical samples. Robust
quality processes support our team of scientists in the delivery of
submission ready data.
The Company has a leading portfolio of 8 viral challenge study
models which are: 2 FLU, 2 RSV, 1 HRV, 1 Asthma, 1 cough and 1 COPD
viral challenge models. As announced in early March, Open Orphan is
rapidly advancing a number of Coronavirus challenge study models
and expects to be helping many COVID-19 vaccine development
companies to test their vaccines. No other company in the world has
such a portfolio, with only two competitors globally having 1
challenge study model each. hVIVO also works with companies in the
UK and Ireland to provide COVID-19 testing to staff to protect
staff and customers from a workplace COVID-19 outbreak through its
COVID Clear offering.
Open Orphan comprises of two commercial specialist CRO services
businesses, hVIVO and Venn Life Sciences and is also building out a
valuable data platform business. hVIVO has built up one of the
world's largest databases of infectious disease progression data
and we are populating our Open Orphan Health Data platform with
this historical hVIVO data. In our clinical trials going forward,
we are also planning to collect data on volunteer's via wearables
during clinical trials. Therefore, Open Orphan's data, which may
yield valuable digital biomarkers, could be one of the more
sought-after datasets by many of the large wearables /smart watch
wearables providers around the world. In June 2019, Open Orphan
acquired AIM-listed Venn Life Sciences Holdings plc in a reverse
take-over and in January 2020 it completed the merger with hVIVO
plc in January 2020. Venn is an integrated drug development
consultancy firm which offers CMC (chemistry, manufacturing and
controls), preclinical, Phase I & II clinical trials design and
execution. The merger with hVIVO created a European full pharma
services company broadening the Company's customer base and with
complementary specialist CRO services, widened the range of the
Company's service offerings.
Notes to Editors - HIC-Vac:
HIC-Vac is an international network of researchers who are
developing human infection challenge (HIC) studies to accelerate
the development of vaccines against pathogens of high global
impact.
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