Wellcome Trust grants Mucosis €3.7m for clinical trials in partnership with Imperial College

Dutch biotechnology firm Mucosis, a developer of next-generation and needle-free human vaccines for infectious diseases, has secured a €3.7m translational fund award from the Wellcome Trust to progress its proprietary intranasal respiratory syncytial virus (RSV) vaccine, SynGEM, into Phase I and IIa human clinical trials.

The trials will be led by Professor Peter Openshaw, an expert in RSV and member of Mucosis’s Scientific Advisory Board, and Dr Christopher Chiu of the National Heart & Lung Institute, Imperial College London.

Openshaw, Professor of Experimental Medicine at Imperial and Honorary Physician in the Department of Respiratory Medicine at the St Mary's Campus of the Imperial College NHS Trust, said: 'RSV is one of the few major infectious diseases for which there is still no vaccine. Contracting under Mucosis, this funding will enable us to analyse the immune responses generated by SynGEM and increase our understanding of protective immunity in the respiratory system.'

RSV is a major cause of severe lower respiratory tract infections such as pneumonia and represents a large unmet medical need. According to the World Health Organisation (WHO), RSV is estimated to affect 64 million people globally and cause 160,000 deaths every year, as well as associated increased allergy and asthma rates. While RSV infects all age groups, the most severe cases occur in the elderly, patients with chronic lung disease, individuals with impaired immunity and very young infants.

We are pleased to have secured additional funding to more quickly advance a needle-free vaccine for RSV into the clinic

The Wellcome Trust funding will be used for a Phase I dose-finding and safety study, followed by a novel phase II challenge study to assess the efficacy of the SynGEM vaccine against controlled infection with RSV.

SynGEM is based on Mucosis’s proprietary bacterium-like-particle (BLP) based Mimopath platform, which allows the vaccine to be delivered via mucosal routes, primarily the nose, making the vaccine needle-free.

Tom Johnston, CEO of Mucosis, which is located in Groningen, said: 'SynGEM has performed exceptionally well in pre-clinical trials and we are pleased to have secured additional funding to more quickly advance a needle-free vaccine for RSV into the clinic.'

Mucosis has also secured €2m additional equity financing from its current investors to enable the firm to complete GMP manufacturing, and to advance the Investigational Medicinal Product Dossier (IMPD) submission materials for clinical trial approval during 2016.

The firm also previously secured €5m from the Netherlands Enterprise Agency (RVO) for the development of SynGEM.