# hVIVO phase I results for Imutex’s mosquito vaccine published in eBioMedicine

- Link: https://www.directorstalkinterviews.com/hvivo-phase-i-results-for-imutexs-mosquito-vaccine-published-in-ebiomedicine/4121094906
- Published: 2022-12-19T07:08:25+00:00
- Author: Giles

**[hVIVO plc](https://www.directorstalkinterviews.com/company/hvivo-plc/hvo.l)**(
[LON:HVO](https://www.directorstalkinterviews.com/company/hvivo-plc/hvo.l)) (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, has announced 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.”_

> “The positive data from the first in human AGS-V PLUS Phase I clinical trial has
> been published in eBioMedicine a leading 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.
> 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.” **Cathal Friel chairman of Hivo** 

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.

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