TIDMORPH
RNS Number : 2256U
Open Orphan PLC
28 July 2020
28 July 2020
Open Orphan plc
("Open Orphan" or the "Company")
Awarded Contract from Codagenix Inc. New York USA for COVID-19
Vaccine Trial
Open Orphan plc (ORPH), 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 a new contract with Codagenix Inc.
("Codagenix") to conduct a first in human (Phase I) trial
evaluating safety and immunogenicity of a single-dose, intranasal
SARS-CoV-2 (COVID-19) vaccine candidate in 48 healthy young adult
volunteers.
Highlights:
-- First in human (Phase I) study of CodaVax-COVID, a codon
deoptimized SARS-CoV-2 (COVID-19) single-dose, intranasal vaccine
candidate
-- Vaccine being trialled at hVIVO's state-of-the-art Quarantine
Facility in Whitechapel in London
-- Phase I study to start in early Autumn with initial data expected by the end of 2020
-- Study will include second dose as surrogate viral challenge at Day 28
hVIVO, part of Open Orphan, will conduct the COVID-19 vaccine
trial for Codagenix at its state-of-the-art Quarantine Facility.
CodaVax-COVID is a live-attenuated vaccine that replicates very
slowly, but contains all SARS-CoV-2 proteins, unlike most other
vaccines that only contain the viral spike. This vaccine has the
potential to induce broad antibody, cellular and mucosal immunity
with a single intranasal dose. hVIVO is currently kicking off the
initial steps of this exciting study and are expected to start the
trial in the quarantine unit this autumn.
This contract reinforces Open Orphan's position as the world
leader in the testing of vaccines and antivirals.
Cathal Friel, Executive Chairman, Open Orphan, said:
"We are proud to be conducting this Phase I study for Codagenix,
a leader in their field, as it will help bring a promising vaccine
candidate to the public to help combat the COVID-19 pandemic as
quickly as possible.
hVIVO, with its unique quarantine facility, is one of the few
organisations in the world that has now publicly stated that it is
working on testing COVID-19 vaccines for efficacy using human
challenge model clinical trials.
Today's announcement also shows that hVIVO's quarantine facility
is uniquely suited to conducting Phase I studies for infectious
disease vaccines such as this.
Codagenix's expertise in viral design technology, combined with
hVIVO's Phase I trial capability, gives us confidence that this
trial will be successful and a step forward for the world as it
seeks to develop a COVID-19 vaccine to bring the pandemic to a
close."
Sybil Tasker, MD, MPH, Chief Medical Officer of Codagenix,
said:
"We are very excited to be collaborating with hVIVO for the
first-in-human study of CodaVax-COVID. hVIVO is world-recognized
for expertise in evaluation of live viruses in human volunteers.
Based on our animal data we expect this vaccine to be effective
with a single dose, but will also evaluate a repeat dose to assess
potential for boosting and as a model for protection from wildtype
challenge.
We plan to move quickly from this initial demonstration of
safety and immunogenicity in a controlled inpatient setting to
larger Phase 2/3 program in conjunction with our partners at Serum
Institute of India who are currently scaling up manufacturing to
support rapid acceleration of our joint development program."
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 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 which 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. In June 2020 hVIVO COVID Clear Test was
launched, the most accurate antibody test available to UK
employers, helping them to get their people back to work.
Open Orphan comprises of two commercial specialist CRO services
businesses ( hVIVO and Venn ) and is developing an early stage
orphan drug genomics data platform business. This platform captures
valuable genetic data from patient populations with specific
diseases with designated orphan drug status and incorporating AI
tools. 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, as an integrated drug
development consultancy, 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 - Codagenix Inc.
Codagenix is a clinical-stage synthetic biology company that
uses software to recode the genomes of viruses, constructing
live-attenuated vaccines or viruses to prevent viral infections or
treat solid tumours. Codagenix's recoded vaccine candidates are a
perfect antigenic match to the target virus and induce a robust
immune response to all viral antigens. For cancer, our nimble
platform allows us to turn a virus into a potential oncolytic
immuno-oncology therapy. Both programs rely on scalable, low-cost
manufacturing. Codagenix Inc. spun out of the laboratory of
National Academy of Science Member Eckard Wimmer at Stony Brook
University in 2012 and is located at the Broad Hollow Bioscience
Research Park in Farmingdale, N.Y. Our programs are supported by
Adjuvant Capital, TopSpin Partners, Euclidean Capital, and
government agencies such as the USDA, NIH/NIAID and the Department
of Defense.
For more information, visit www.codagenix.com.
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END
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