hVIVO Phase I results for Imutex’s mosquito vaccine candidate published

hVIVO plc (LON: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, 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.”

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.

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