hVIVO Regulatory News (HVO)

hVIVO plc

("hVIVO" or the "Company")

A Phase 1 clinical trial of AGS-v PLUS a Universal mosquito-borne diseases vaccine candidate

- AGS-v PLUS was developed by Imutex Limited, hVIVO's 49% joint venture with the SEEK Group

- The trial will be conducted by the National Institutes of Health (NIH) and will take place at the University of Maryland School of Medicine

- The study received additional funding from the UK Department of Health and Social Care, managed by Innovate UK

London, UK, 31 July 2019: hVIVO plc (AIM: HVO), an industry leading clinical development services business pioneering human disease models based upon viral challenge, confirms that AGS-v PLUS, an experimental vaccine designed to protect against many different mosquito-borne diseases, will be tested in a Phase 1 clinical trial by the NIH at the University of Maryland School of Medicine (NCT04009824). The vaccine, AGS-v PLUS, was developed by Imutex Limited, hVIVO's 49% joint venture with the SEEK Group. The study received additional funding from the UK Department of Health and Social Care, managed by Innovate UK.

AGS-v PLUS is designed to provoke an immune reaction to the proteins in mosquito saliva, which can carry many different pathogens, including Zika and Malaria. This clinical trial will test the vaccine's safety and immunogenicity when given with or without adjuvant to small groups of healthy volunteers. The vaccine may also have a mosquito control component-the trial will collect data on the fertility of mosquitoes which feed on vaccinated volunteers. The National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, previously tested an earlier version of this vaccine, AGS-v, in a first-in-human trial conducted in NIAID's Laboratory of Infectious Diseases' Special Clinical Studies Unit at the NIH Clinical Center in Bethesda, Maryland, and final results of this trial are expected in due course (NCT03055000).

Trevor Phillips, Executive Chairman of hVIVO, said: "It is great to see the relationship with NIH and the University of Maryland School of Medicine continues as AGS-v PLUS, one of the assets in our joint venture Imutex, moves into the clinic. We are pleased that the development of this asset is continuing with NIAID-funded researchers testing the vaccine and additional funding for the study by Innovate UK."

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Notes to Editors:

hVIVO is pioneering a human-based clinical trial platform to accelerate drug and vaccine development in respiratory and infectious diseases. Leveraging human disease models in HRV, RSV, Flu Asthma and COPD, 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 50 clinical studies and inoculated over 2500 volunteers.

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