TIDMORPH
RNS Number : 4585I
Open Orphan PLC
14 December 2020
Open Orphan plc
("Open Orphan" or the "Company")
MHRA approval for nasal COVID-19 vaccine clinical trial
First in human trials for vaccine candidate with the potential
to confer long-term immunity
Open Orphan plc (AIM: ORPH), a rapidly growing specialist
pharmaceutical services CRO which is the world leader in the
testing of vaccines and antivirals using human challenge clinical
trials, announce s the first in human (Phase I) study of Codagenix
intranasal SARS-CoV-2 (COVID-19) vaccine candidate has received
approval from the UK's independent Medicines and Healthcare
Products Regulatory Agency (MHRA).
Further to the Company's announcement on 28 July 2020, hVIVO,
part of Open Orphan plc, is working in collaboration with US
biotech Codagenix Inc. ("Codagenix") to conduct this Phase I study
of COVI-VAC , Codagenix's intranasal SARS-CoV-2 (COVID-19) vaccine
candidate. The study will evaluate s afety and immunogenicity of a
single-dose nasal vaccine candidate in 48 healthy young adult
volunteers at hVIVO's state-of-the-art Quarantine Facility in
Whitechapel, London.
COVI-VAC is one of the few vaccines that uses the
live-attenuated virus (i.e. the entire virus in a weakened form),
unlike most other vaccines which only contain the viral spike. This
vaccine, therefore, has the potential to induce broad antibody,
cellular and mucosal immunity with a single intranasal dose and
could be one of the first vaccines to provide long-term immunity
from COVID-19.
hVIVO expects the study to commence in January 2021, the initial
data expected in early Q2 2020. The Company has already begun
enrolling volunteers for this study in its unique East London,
24-bedroom quarantine clinic through hVIVO's dedicated volunteer
recruitment website: www.flucamp.com
Cathal Friel, Executive Chairman of Open Orphan, said:
"We are delighted to have MHRA approval to begin recruiting
volunteers for this much needed clinical trial. The volunteers who
attend our unique quarantine facility in East London are expertly
supervised in a safe, controlled clinical environment and could be
contributing to the development of a new breakthrough vaccine
candidate that has the potential to confer immunity to individuals
over a much longer timescale.
"We hope to demonstrate safety and immunogenicity through this
trial, which will then allow us to support Codagenix as they move
into a larger Phase II / Phase III programme."
Sybil Tasker, MD, MPH, Chief Medical Officer of Codagenix,
said:
"We are very excited to be moving forward with our collaboration
with hVIVO for this first-in-human study of COVI-VAC, our live
attenuated vaccine against COVID-19. The initial safety and
immunogenicity data from healthy adults will position us well to
move into larger studies in 2021 with our partners at Serum
Institute of India. We believe COVI-VAC, a needle-free, single dose
vaccine, is well-suited to address potential gaps in supplying the
global community, as there is likely to be significant unmet need
even after the initial roll-out of first generation COVID-19
vaccines."
Dr. Rajeev Dhere, Executive Director, Serum Institute of India,
said:
"We at the Serum Institute of India are pleased with the MHRA
approval for initiating the first-in-human clinical trial for the
novel intranasal product against COVID-19, developed by Codagenix
in collaboration with SII. We are happy to have hVIVO conducting
the clinical trial of this unique Intranasal vaccine."
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 500
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 / Alice Woodings +44 (0)7980 541 893 / +44 (0)7407 804
654
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 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.
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