TIDMHVO
hVIVO PLC
19 December 2022
hVIVO plc
("hVIVO" or the "Company")
Phase I results for Imutex's mosquito vaccine candidate
published in leading peer-reviewed journal
hVIVO plc (AIM & Euronext: HVO) (formerly Open Orphan plc),
a rapidly growing specialist contract research organisation (CRO)
and world leader in testing infectious and respiratory disease
products using human challenge clinical trials, announces
publication of previously reported positive data from a
first-in-human Phase I clinical study evaluating the safety and
immunogenicity of AGS-v PLUS. The data has been published in
eBioMedicine,(1) a peer-reviewed open access biomedical journal
part of The Lancet Discovery Science.
AGS-v PLUS is a vaccine candidate against arboviral diseases
that targets the saliva of the mosquito rather than the pathogens
carried by the mosquito. AGS-v PLUS is owned by Imutex Ltd, a joint
venture with PepTcell Limited (the parent company of ConserV
Bioscience Ltd), in which hVIVO has a 49% shareholding.
AGS-v PLUS vaccine candidate has a novel proposed dual action
mechanism of preventing infection in humans whilst controlling the
mosquito population through affecting reproduction. AGS-v PLUS
contains five synthetic peptides that originate from proteins found
in the saliva of mosquitoes. The published manuscript shows data
from the study conducted at the University of Maryland School of
Medicine and sponsored by NIAID-NIH, demonstrating that all AGS-v
PLUS formulations evaluated (non-adjuvanted or adjuvanted in
alhydrogel or Montanide ISA-51) were well tolerated with no serious
adverse events experienced, and that they generated a robust
cellular and humoral immune response in participants, the
formulation in Montanide ISA-51 being the most immunogenic.
Moreover, the immune response mounted against AGS-v PLUS was shown
to reduce infectivity of Zika virus in vitro.
Mosquito-borne diseases include Zika, West Nile, chikungunya,
dengue, yellow fever, and malaria amongst others. There are 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.
Yamin 'Mo' Khan, Chief Executive Officer of hVIVO, said: "It is
encouraging to see the results from Imutex's first-in-human Phase 1
trial for AGS-v PLUS published in eBioMedicine. The data
demonstrated that AGS-v PLUS was well tolerated and generated a
robust immune response in participants, with no serious adverse
events. The next steps will be to determine if these findings
translate into clinical efficacy against mosquito-borne diseases,
which inflict a severe burden on public health systems around the
world."
1. "Safety and immunogenicity of AGS-V plus, a mosquito saliva
peptide vaccine against arboviral diseases: A randomized,
double-blind, placebo-controlled phase 1 trial," by
Friedman-Klabanoff, D.A.J. et al. (2022) is available in
eBioMedicine, part of The Lancet, 86, p. 104375. DOI:
https://doi.org/10.1016/j.ebiom.2022.104375
2. Institute for Health Metrics and Evaluation (IHME). Global
Burden of Disease 2019 Cause and Risk Summary: Malaria, Dengue,
Yellow Fever, Zika; 2020. Accessed April 6, 2021.
For further information please contact:
hVIVO plc +44 (0) 20 7756 1300
Yamin 'Mo' Khan, Chief Executive
Officer
Stephen Pinkerton, Chief Financial
Officer
Liberum Capital (Nominated Adviser and
Joint Broker) +44 (0) 20 3100 2000
Ben Cryer, Edward Mansfield, Phil Walker,
Will King
finnCap plc (Joint Broker) +44 (0) 20 7220 0500
Geoff Nash, Charlie Beeson, Nigel Birks,
Harriet Ward (ECM)
Davy (Euronext Growth Adviser and Joint
Broker) +353 (0) 1 679 6363
Anthony Farrell, Niall Gilchrist
Walbrook PR (Financial PR & IR) +44 (0) 20 7933 8780 or hvivo@walbrookpr.com
Stephanie Cuthbert / Phillip +44 (0) 7796 794 663 / +44 (0) 7867 984
Marriage / 082 /
Louis Ashe-Jepson +44 (0) 7747 515 393
Notes to Editors
hVIVO plc (ticker: HVO) (formerly Open Orphan plc) is a rapidly
growing specialist contract research organisation (CRO) and the
world leader in testing infectious and respiratory disease vaccines
and therapeutics using human challenge clinical trials. The Group
provides end-to-end early clinical development services to its
large, established and growing repeat client base, which includes
four of the top 10 largest global biopharma companies.
The Group's fast-growing services business includes a unique
portfolio of 10+ human challenge models to test a broad range of
infectious and respiratory disease products, world class challenge
agent manufacturing, specialist drug development and clinical
consultancy services via its Venn Life Sciences brand, and a lab
offering via its hLAB brand, which includes virology, immunology
biomarker and molecular testing. The Group offers additional
clinical field trial services such as patient recruitment and
clinical trial site services.
hVIVO runs challenge studies in London from its Whitechapel
quarantine clinic, its state-of-the-art QMB clinic with its highly
specialised on-site virology and immunology laboratory, and its
clinic in Plumbers Row. To recruit volunteers / patients for its
studies, the Company leverages its unique clinical trial
recruitment capacity via its FluCamp volunteer screening facilities
in London and Manchester.
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. ConserV Bioscience is a late-stage vaccine
development company focused on advancing safe and effective
vaccines that protect against endemic and emergent infectious
diseases. They use a novel in silico proprietary platform to
identify highly conserved regions in the proteome that contain a
high number of reactive T-cell epitopes with extensive HLA
coverage. These regions are then used as antigens and are delivered
using the most appropriate method for the combination of antigens
and the disease, for example, as synthetic peptides or encoded in
mRNA. This approach has consistently identified promising vaccine
candidates which have demonstrated immunogenic responses in
pre-clinical validation studies and have achieved mid- and
late-stage clinical milestones.
www.conservbio.com
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