TIDMORPH
RNS Number : 1421L
Open Orphan PLC
11 January 2021
11 January 2021
Open Orphan plc
("Open Orphan" or the "Company")
First volunteer dosed in intran asal COVID-19 vaccine clinical
trial
Open Orphan plc (AIM: ORPH), a rapidly growing specialist
pharmaceutical services CRO and a world leader in vaccine and
antiviral testing using human challenge clinical trials, announces
that the first volunteer has been dosed with the Codagenix Inc.
("Codagenix") needle free, intranasal COVID-19 vaccine, COVI-VAC.
Conducted by hVIVO, part of Open Orphan plc, the Phase I clinical
trial of COVI-VAC is being carried out at their facility in the UK.
COVI-VAC is a single-dose, intranasal, live attenuated (the entire
virus in a weakened form) vaccine against SARS-CoV-2, the virus
that causes COVID-19.
Further to the Company's announcement on 28 July 2020, hVIVO is
working in collaboration with US biotech Codagenix to conduct a
Phase I study of COVI-VAC. This is a randomised, double-blinded,
placebo-controlled dose-escalation study, and will evaluate the
safety and tolerability of the single-dose intranasal vaccine
candidate in 48 healthy young adult volunteers at hVIVO's
state-of-the-art Quarantine Facility in Whitechapel, London.
The study will also evaluate the vaccine's ability to provoke an
immune response - measuring neutralising antibodies, mucosal
immunity in the airway and cellular immunity. COVI-VAC has the
potential to address several key logistical challenges to
immunisation against SARS-CoV-2 at a global scale. As a
single-dose, intranasally-delivered vaccine, COVI-VAC will not
require a needle and syringe to be administered, nor ultra-low
temperature freezers for storage. COVI-VAC can be manufactured on a
large scale and supports ease of administration in a mass
vaccination campaign. Codagenix expects to report initial data from
the study by mid-2021.
Cathal Friel, Executive Chairman, Open Orphan, commented: "We
are delighted to have been chosen by the New York based Codagenix
to run this very important COVID-19 vaccine study in our quarantine
clinic in London. This vaccine is one of the first of the next
generation COVID-19 vaccines, it is a single dose, needle free,
intranasal, live attenuated COVID-19 virus vaccine. Thus, in our
opinion, because it is a live attenuated virus vaccine, COVI-VAC
has the potential to give much longer-lasting cellular immunity
against COVID-19 than many of the first-generation vaccines.
"Codagenix sought an inpatient facility for the first in human
evaluation of COVI-VAC to allow for thorough evaluation of product
safety and real-time volunteer monitoring, and our unique
state-of-the-art quarantine facility in East London is one of the
few facilities in the world suitable to conduct this trial safely
and successfully. hVIVO are providing a full-service trial as part
of this contract with Codagenix and the team at FluCamp have been
responsible for all aspects of trial recruitment for this study
through www.FluCamp.com .
"hVIVO is world-recognised for its expertise in evaluation of
live viruses in human volunteers and we look forward to a positive
outcome."
Sybil Tasker, MD, MPH, Chief Medical Officer of Codagenix, said:
"Dosing of the first patients in the Phase 1 clinical trial of
COVI-VAC, our single-dose, intranasal, live attenuated vaccine
against COVID-19, is an important milestone for Codagenix and the
hVIVO team. As a live attenuated vaccine, COVI-VAC has the
potential to provide a broader immune response in comparison to
other COVID-19 vaccines that target only a portion of the virus,
which could prove critical as new variants of SARS-CoV-2 have begun
to emerge. Additionally, we believe COVI-VAC can address potential
gaps in supplying the global immunization effort against COVID-19,
especially in developing countries ."
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 . hVIVO welcomes volunteers to take part
in our clinical trials under expertly supervised conditions, to
further medical research, and help us to take the understanding of
respiratory illnesses to a new level. Volunteers are central to the
work that we do; our studies focus on testing new treatments on
real people, in a safe, controlled, clinical environment.
Further details on all aspects of our volunteer programs
including testimonials from previous volunteers can be found at
www.flucamp.com .
If you are interested in being contacted and provided with
details about future COVID-19 human challenge study research,
please leave your contact details at www.UKCovidChallenge.com .
For further information please contact:
Open Orphan plc +353 (0) 1 644 0007
Cathal Friel, Executive Chairman
Arden Partners plc (Nominated Adviser
and Joint Broker) +44 (0) 20 7614 5900
John Llewellyn-Lloyd / Benjamin Cryer
/ Dan Gee-Summons
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 & +44 (0)20 7933 8780 or openorphan@walbrookpr.com
IR)
+44 (0)7876 741 001 / +44
Anna Dunphy / Paul McManus (0)7980 541 893
About Open Orphan ( www.openorphan.com )
Open Orphan is a rapidly growing niche CRO pharmaceutical
services company which is a 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 volunteers 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. 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.
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