RCS - hVIVO PLC - Imutex Phase I data published

hVIVOAnnouncement

19/12/2022 07:00

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RNS Number : 0710K  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
(https://www.londonstockexchange.com/news-article/HVO/imutex-vaccine-phase-i-study-results/15218248)
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
(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 Marriage /         +44 (0) 7796 794 663 / +44 (0) 7867 984 082 /

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
(https://eur05.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.flucamp.com%2F&data=05%7C01%7CCarol.Dalton%40openorphan.com%7Cfb9f1a50aaa9492d81ed08da875cca71%7C131abc777e104bbd90170559abc5d601%7C1%7C0%7C637971129881295595%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=fQdtQTHu9Bo70yRgWcZW5liNTXPYiWl9YayUA01E%2FlA%3D&reserved=0)
 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 (http://www.conservbio.com)

 

 

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