TIDMHVO
hVIVO plc
21 February 2017
For immediate release 16:25: 21 February 2017
HVIVO PLC
("hVIVO" or the "Company")
hVIVO notes the initiation of a Phase I clinical trial with
AGS-v, a mosquito-borne disease vaccine candidate
Vaccine could protect against diseases such as Zika and
Malaria
hVIVO's joint venture investment with SEEK in a new company,
Imutex, was formed to accelerate the development of this
vaccine
hVIVO plc (AIM: HVO), a specialty biopharma company with
discovery and clinical testing capabilities, notes the announcement
from the US National Institute of Health (NIH) that it has
initiated a Phase I clinical trial of AGS-v, an investigational
mosquito-borne disease vaccine. AGS-v is intended to provide broad
protection against a range of mosquito-transmitted diseases, such
as Zika, malaria, West Nile fever and dengue fever, and to hinder
the ability of mosquitoes to transmit such infections. The National
Institute of Allergy and Infectious Diseases (NIAID), part of the
NIH, is leading the trial, which will enrol up to 60 healthy adults
ages 18-50 years, and is designed to test the safety of the
investigational vaccine, as well as its ability to prompt an immune
response in human subjects.
In 2016, hVIVO formed a joint venture with London-based SEEK
Group (SEEK) in a new company, Imutex Limited (Imutex), to
accelerate the development of SEEK's AGS-v vaccine and
broad-spectrum influenza vaccine (BIV), FLU-v. Such vaccines are
key public health priorities identified by the Centers for Disease
Control and Prevention (CDC), the NIH, and other international
health authorities. SEEK, through its parent company PepTcell
Limited, has a clinical trial agreement with NIAID to conduct the
Phase I study at the NIH Clinical Center in Bethesda, Maryland
under the direction of Matthew J. Memoli, M.D., Director of the
Clinical Studies Unit in NIAID's Laboratory of Infectious
Diseases.
Unlike other vaccines targeting specific mosquito-borne
diseases, AGS-v is designed to trigger an immune response to
mosquito saliva rather than a specific virus or parasite carried by
mosquitoes. The test vaccine contains four synthetic proteins from
mosquito salivary glands. The proteins are designed to induce
antibodies in a vaccinated individual and to cause a modified
allergic response that can prevent infection when a person is
bitten by a disease-carrying mosquito.
Kym Denny, CEO of hVIVO, commented,
"This vaccine has the potential to shift the balance of power in
the fight against mosquito-borne disease, and is an excellent
example of the UK's ability to translate insightful science into a
potentially ground-breaking product. We are excited to commence the
Phase I study with our partners at SEEK under the excellent
stewardship of the team at NIAID, and I look forward to reporting
progress on the trial in the coming year."
The full text of the NIH release is reproduced below
(https://www.niaid.nih.gov/news-events/nih-begins-study-vaccine-protect-against-mosquito-borne-diseases):
NIH Begins Study of Vaccine to Protect Against Mosquito-Borne
Diseases
Experimental Vaccine Targets Mosquito Saliva
The National Institute of Allergy and Infectious Diseases
(NIAID), part of the National Institutes of Health (NIH), has
launched a Phase 1 clinical trial to test an investigational
vaccine intended to provide broad protection against a range of
mosquito-transmitted diseases, such as Zika, malaria, West Nile
fever and dengue fever, and to hinder the ability of mosquitoes to
transmit such infections. The study, which is being conducted at
the NIH Clinical Center in Bethesda, Maryland, will examine the
experimental vaccine's safety and ability to generate an immune
response.
The investigational vaccine, called AGS-v, was developed by the
London-based pharmaceutical company SEEK, which has since formed a
joint venture with hVIVO in London. The consulting group Halloran
has provided regulatory advice to both companies.
Unlike other vaccines targeting specific mosquito-borne
diseases, the AGS-v candidate is designed to trigger an immune
response to mosquito saliva rather than to a specific virus or
parasite carried by mosquitoes. The test vaccine contains four
synthetic proteins from mosquito salivary glands. The proteins are
designed to induce antibodies in a vaccinated individual and to
cause a modified allergic response that can prevent infection when
a person is bitten by a disease-carrying mosquito.
"Mosquitoes cause more human disease and death than any other
animal," said NIAID Director Anthony S. Fauci, M.D. "A single
vaccine capable of protecting against the scourge of mosquito-borne
diseases is a novel concept that, if proven successful, would be a
monumental public health advance."
Led by Matthew J. Memoli, M.D., director of the Clinical Studies
Unit in NIAID's Laboratory of Infectious Diseases, the clinical
trial is expected to enroll up to 60 healthy adults ages 18 to 50
years. Participants will be randomly assigned to receive one of
three vaccine regimens. The first group will receive two injections
of the AGS-v vaccine, 21 days apart. The second group will receive
two injections of AGS-v combined with an adjuvant, 21 days apart.
The adjuvant is an oil and water mixture commonly added to vaccines
to enhance immune responses. The third group will receive two
placebo injections of sterile water 21 days apart. Neither the
study investigators nor the participants will know who is assigned
to each group.
Participants will be asked to return to the clinic twice between
vaccinations and twice after the second vaccination to undergo a
physical exam and to provide blood samples. Study investigators
will examine the blood samples to measure levels of antibodies
triggered by vaccination.
Each participant also will return to the Clinical Center
approximately 21 days after completing the vaccination schedule to
undergo a controlled exposure to biting mosquitoes. The mosquitoes
will not be carrying viruses or parasites, so the participants are
not at risk of becoming infected with a mosquito-borne disease.
Five to 10 female Aedes aegypti mosquitoes from the insectary in
NIAID's Laboratory of Malaria and Vector Research will be put in a
feeding device that will be placed on each participant's arm for 20
minutes. The mosquitoes will bite the participants' arms through
the netting on the feeding devices.
Afterward, investigators will take blood samples from each
participant at various time points to see if participants
experience a modified response to the mosquito bites as a result of
AGS-v vaccination.
Investigators also will examine the mosquitoes after the feeding
to assess any changes to their life cycle. Scientists suspect that
the mosquitoes who take a blood meal from ASG-v-vaccinated
participants may have altered behavior that could lead to early
death or a reduced ability to reproduce. This would indicate that
the experimental vaccine could also hinder disease transmission by
controlling the mosquito population.
All participants will be asked to return to the clinic for
follow-up visits every 60 days for five months following the
mosquito feeding. A final clinic visit to assess long-term safety
will take place approximately 10 months after the mosquito feeding.
Throughout the trial, an independent Data and Safety Monitoring
Board will review study data to evaluate participant safety and the
overall conduct of the study. A medical monitor from NIAID's Office
of Clinical Research Policy and Regulatory Operations will also
perform routine safety assessments.
The study is expected to be completed by summer 2018. For more
information about the trial, see clinicaltrials.gov using the trial
identifier NCT03055000.
NIAID conducts and supports research-at NIH, throughout the
United States, and worldwide-to study the causes of infectious and
immune-mediated diseases, and to develop better means of
preventing, diagnosing and treating these illnesses. News releases,
fact sheets and other NIAID-related materials are available on the
NIAID website.
About the National Institutes of Health (NIH): NIH, the nation's
medical research agency, includes 27 Institutes and Centers and is
a component of the U.S. Department of Health and Human Services.
NIH is the primary federal agency conducting and supporting basic,
clinical, and translational medical research, and is investigating
the causes, treatments, and cures for both common and rare
diseases. For more information about NIH and its programs, visit
www.nih.gov.
For further information please contact:
hVIVO plc +44 207 756 1300
Kym Denny (Chief Executive Officer)
Graham Yeatman (Chief Financial & Business
Officer)
+44 203 021 3933 / +44
Media Enquiries 7854 979 420
Colin Paterson (Director of Marketing,
Communication and Public Relations)
Numis Securities Limited +44 207 260 1000
Michael Meade / Freddie Barnfield (Nominated
Adviser)
James Black / Michael Burke (Corporate
Broking)
FTI Consulting
Simon Conway / Victoria Foster Mitchell
(UK) +44 203 727 1000
John Capodanno / Evan Smith (US) +1 212 850 5705
Notes to Editors:
About hVIVO plc
hVIVO plc ("hVIVO"), a specialty biopharma company with
discovery and clinical testing capabilities, is pioneering a
human-based analytical platform to accelerate drug discovery and
development in respiratory and infectious diseases. Leveraging
human disease models in flu, RSV and asthma exacerbation, the hVIVO
platform captures disease in motion, illuminating the entire
disease life cycle from healthy to sick and back to health. Based
in the UK, market leader hVIVO has conducted more than 45 clinical
studies, inoculated over 2000 volunteers and has three
first-in-class therapies currently in development with a growing
pre-clinical pipeline.
The company news service from the London Stock Exchange
END
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