TIDMORPH
RNS Number : 8975S
Open Orphan PLC
19 November 2021
19 November 2021
Open Orphan plc
("Open Orphan" or the "Company")
Imutex to present positive Phase I clinical study results for
AGS-v PLUS mosquito vaccine candidate
AGS-v PLUS mosquito vaccine candidate shows favourable safety,
tolerability, and immunogenicity results
Results to be presented at the American Society of Tropical
Medicine and Hygiene Annual Meeting
Open Orphan plc (AIM: ORPH) announces that data from the
first-in-human Phase I clinical study evaluating the safety,
immunogenicity, and in vitro efficacy of AGS-v PLUS, Imutex
Limited's ("Imutex') mosquito saliva vaccine candidate against
arboviral diseases, as well as data on the candidate's effect on
the reproductive capacity of mosquitoes that fed on vaccinated
subjects will be presented on the 20(th) and 21(st) of November
2021. Imutex Limited ("Imutex") is a joint venture with PepTcell
Limited ("PepTcell") (the legal name of SEEK Group) in which Open
Orphan has a 49% shareholding.
The results will be presented in two virtual sessions at the
American Society of Tropical Medicine and Hygiene ("ASTMH") Annual
Meeting, held from 17-21 November 2021. The titles and details of
the two presentations are as follows:
-- "Blood feeding on humans vaccinated with AGS-v PLUS, a
mosquito salivary peptide vaccine, impairs the reproductive
capacity of female Aedes albopictus mosquitoes" - Scientific
Session 91: Mosquitoes-Vector Biology Epidemiology I, at 8.00 am
(ET) on 20 November 2021. To be presented by Joshua Lacsina, M.D.,
Ph.D. of the Laboratory of Malaria and Vector Research at the
National Institute of Allergy and Infectious Diseases.
-- " Safety and immunogenicity of AGS-v PLUS, a mosquito saliva
peptide vaccine against arboviral diseases" - Scientific Session
126: Clinical Tropical Medicine: Vector borne Disease, at 8.00 am
(ET) on 21 November 2021. To be presented by DeAnna J.
Friedman-Klabanoff, M.D. of the University of Maryland School of
Medicine.
Following the presentations, Imutex expect to publish the
results from the study in a scientific peer-reviewed journal.
Imutex was funded by the Department of Health and Social Care as
part of the UK Vaccine Network (UKVN), a UK Aid programme to
develop vaccines for diseases with epidemic potential in low and
middle-income countries (LMICs) to carry out this study.
Data from this study, which was performed at the University of
Maryland School of Medicine (Baltimore, Maryland, U.S.) and is
related to a collaboration between PepTCell and The National
Institute of Allergy and Infectious Diseases (NIAID), part of the
National Institutes of Health (NIH), demonstrated that AGS-v PLUS
was well tolerated with no serious adverse events experienced, and
that it generated a strong immune response in participants. AGS-v
PLUS showed a more robust immune response compared to AGS-v, a
first-generation vaccine candidate developed by Imutex. The study
evaluating the effect of AGS-v PLUS on the reproductive capacity of
mosquitoes that fed on vaccinated subjects found that a regimen of
the vaccine in combination with an adjuvant resulted in fewer eggs
laid and adult progeny in the species Aedes albopictus .
Imutex's AGS-v and AGS-v PLUS vaccine candidates are
mosquito-borne disease vaccines with a novel proposed dual action
mechanism of preventing infection in humans whilst controlling the
mosquito population. AGS-v is composed of four synthetic peptides
isolated from mosquito salivary glands. The AGS-v PLUS vaccine
contains the same four peptides as AGS-v but adds a fifth synthetic
peptide found in the saliva of many mosquitoes, increasing the
potential breadth of protection.
Mosquito-borne diseases include Zika virus, West Nile virus,
chikungunya virus, dengue, yellow fever, and malaria. There are
around 360 million cases of and more than 600,000 deaths from
mosquito-borne diseases annually, although the true burden is
likely underestimated. A vaccine efficacious against multiple
mosquito-borne diseases could significantly impact public
health.
Imutex is focused on developing broad-spectrum vaccines against
influenza (flu) and mosquito borne diseases. To find out more about
the product developments, both in influenza vaccine development
(FLU-v) and in Zika vaccine development (AGS-v), please visit the
Imutex website: www.imutex.com
Cathal Friel, Executive Chairman of Open Orphan, said : "The
Company has been eagerly anticipating the results from Imutex's
first-in-human Phase 1 clinical trial for its AGS-v PLUS mosquito
vaccine candidate, and we now look forward to the data being
presented at the upcoming ASTMH Annual Meeting.
"The positive data for the AGS-v PLUS mosquito vaccine candidate
is encouraging; data showed AGS-v PLUS was well tolerated and
generated a strong immune response in participants against
mosquito-borne diseases, with an increased immune response compared
to the four peptide AGS-v candidate. Imutex's AGS-v and AGS-v PLUS
vaccine candidates both employ a novel proposed dual action
mechanism that prevents infection in humans whilst controlling
mosquito population by limiting transmission.
"There are more than 600,000 deaths worldwide per year from
mosquito borne diseases, as such, if these positive Phase I results
translate into clinical efficacy, the potential number of lives
saved will be significant."
Dr Olga Pleguezuelos, Chief Science Officer at PepTcell,
commented: "We are very excited about the study results. AGS-v PLUS
was demonstrated to be safe and immunogenic, and not only impacted
the pathogenicity of the Zika virus as seen in an in vitro assay,
but also reduced the number of eggs and adult progeny of mosquitoes
that fed on vaccinated subjects. The next step is to evaluate
clinical efficacy in a controlled human challenge study or in a
study in endemic areas. Many mosquito-borne diseases lack effective
preventative and therapeutic treatments, so AGS-v PLUS could
potentially save many lives."
The information contained within this announcement is deemed by
the Company to constitute inside information as stipulated under
the Market Abuse Regulations (EU) No. 596/2014 (as implemented into
English law) ("MAR"). With the publication of this announcement via
a Regulatory Information Service, this inside information is now
considered to be in the public domain.
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 / Louisa Waddell
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
vaccines and antivirals using human challenge clinical trials. The
Company provides services to Big Pharma, biotech, and
government/public health organisations.
Open Orphan runs challenge studies in London from both its
19-bedroom Whitechapel quarantine clinic and its state-of-the-art
24-bedroom QMB clinic with its highly specialised on-site virology
and immunology laboratory. The Company has a leading portfolio of
human challenge study models for infectious and respiratory
diseases and is developing a number of new models. There has been
an explosion in the growth of the infectious disease market, which
is estimated to grow to in excess of $250bn by 2025. The Group is
focused on refreshing its existing challenge models and develop new
models, such as Malaria, to address the dramatic growth potential
of the global infectious disease market.
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. The
Disease in Motion platform has many potential applications across a
wide variety of end users including big technology, wearables,
pharma, and biotech companies.
Open Orphan's Paris office has been providing biometry, data
management and statistics to its many European pharmaceutical
clients for over 20 years. For over 15 years, the Company's
Netherlands office has been providing drug development consultancy
and services, including CMC (chemistry, manufacturing, and
controls), PK and medical writing, to a broad range of European
clients. Both offices are now also fully integrated with the London
office and working on challenge study contracts as well as
supporting third party trial contracts.
About PepTcell Limited
PepTcell brings safe, effective, and low-cost treatments to
patients, in the shortest time possible, to radically improve human
health in major disease areas. Through its subsidiary ConserV
Bioscience Limited, PepTcell develops vaccines to a broad range of
infectious diseases. Headquartered in London, PepTcell also
researches, develops, and sells over the counter and prescription
medicines.
About ConserV Bioscience Limited
ConserV Bioscience Limited, based in Oxfordshire, United
Kingdom, is a clinical-stage vaccine development company focused on
advancing safe and effective vaccines that protect against endemic
and emergent infectious diseases. Founded in 2020 as a subsidiary
of PepTcell Limited, it has an experienced scientific and
leadership team. It is harnessing its novel in silico proprietary
platform to identify highly conserved regions of viral proteins
that contain a high number of reactive T-cell epitopes with
extensive HLA coverage. ConserV Bioscience has a pipeline of
vaccines at various stages of pre-clinical and clinical development
including vaccine candidates to protect against HIV, Hepatitis C,
Hepatitis B, Rotavirus, Chagas, and broad-spectrum coronavirus.
www.conservbio.com
About The National Institute of Allergy and Infectious
Diseases
The National Institute of Allergy and Infectious Diseases is an
institute in the National Institutes of Health, an agency of the
Unites States Department of Health and Human Services. NIAID's
mission is to better understand infectious, immunologic, and
allergic diseases and to use this knowledge to treat and prevent
such diseases. NIAID also has a mandate to respond to emerging
public health threats. Toward this end, NIAID supports basic and
applied research to expand knowledge in all areas of infectious,
immunologic, and allergic diseases and supports research that
bolsters our ability to appropriately response to emerging and
re-emerging disease threats.
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