hVIVO notes the initiation of a Phase I clinical trial with AGS-v, a mosquito-borne disease vaccine candidate

LONDON, UK I February 21, 2017 I hVIVO plc ( AIM : HVO ), a specialty biopharma company with discovery and clinical testing capabilities, notes the announcement from the US National Institute of Health (NIH) that it has initiated a Phase I clinical trial of AGS-v, an investigational mosquito-borne disease vaccine. AGS-v is intended to provide broad protection against a range of mosquito-transmitted diseases, such as Zika, malaria, West Nile fever and dengue fever, and to hinder the ability of mosquitoes to transmit such infections. The National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, is leading the trial, which will enrol up to 60 healthy adults ages 18-50 years, and is designed to test the safety of the investigational vaccine, as well as its ability to prompt an immune response in human subjects.

In 2016, hVIVO formed a joint venture with London-based SEEK Group (SEEK) in a new company, Imutex Limited (Imutex), to accelerate the development of SEEK's AGS-v vaccine and broad-spectrum influenza vaccine (BIV), FLU-v. Such vaccines are key public health priorities identified by the Centers for Disease Control and Prevention (CDC), the NIH, and other international health authorities. SEEK, through its parent company PepTcell Limited, has a clinical trial agreement with NIAID to conduct the Phase I study at the NIH Clinical Center in Bethesda, Maryland under the direction of Matthew J. Memoli, M.D., Director of the Clinical Studies Unit in NIAID's Laboratory of Infectious Diseases.

Unlike other vaccines targeting specific mosquito-borne diseases, AGS-v is designed to trigger an immune response to mosquito saliva rather than a specific virus or parasite carried by mosquitoes. The test vaccine contains four synthetic proteins from mosquito salivary glands. The proteins are designed to induce antibodies in a vaccinated individual and to cause a modified allergic response that can prevent infection when a person is bitten by a disease-carrying mosquito.

Kym Denny, CEO of hVIVO, commented,
"This vaccine has the potential to shift the balance of power in the fight against mosquito-borne disease, and is an excellent example of the UK's ability to translate insightful science into a potentially ground-breaking product. We are excited to commence the Phase I study with our partners at SEEK under the excellent stewardship of the team at NIAID, and I look forward to reporting progress on the trial in the coming year."

The full NIH press release can be found here:

https://www.niaid.nih.gov/news-events/nih-begins-study-vaccine-protect-against-mosquito-borne-diseases" target="_blank">https://www.niaid.nih.gov/news-events/nih-begins-study-vaccine-protect-against-mosquito-borne-diseases" data-reactid="10">https://www.niaid.nih.gov/news-events/nih-begins-study-vaccine-protect-against-mosquito-borne-diseases

Notes to Editors:

About hVIVO plc
hVIVO plc ("hVIVO"), a specialty biopharma company with discovery and clinical testing capabilities, is pioneering a human-based analytical platform to accelerate drug discovery and development in respiratory and infectious diseases. Leveraging human disease models in flu, RSV and asthma exacerbation, 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 45 clinical studies, inoculated over 2000 volunteers and has three first-in-class therapies currently in development with a growing pre-clinical pipeline.


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