Mucosis B.V. has announced that it has secured a €3.7 million (£2.77 million) 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 world-leading expert in RSV and member of Mucosis’s Scientific Advisory Board, Professor Peter Openshaw FRCP FMedSci and Dr. Christopher Chiu of the National Heart & Lung Institute, Imperial College London.
Professor Peter Openshaw, Professor of Experimental Medicine at Imperial College London and Honorary Physician in the Department of Respiratory Medicine at the St Mary's Campus of the Imperial College NHS Trust welcomed the news, commenting “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 analyze 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 WHO (1), the global RSV disease burden is estimated at 64 million cases and 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.
The Wellcome Trust translational fund award will be used to fund 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. The BLPs carry a unique stable prefusion form of the F vaccine antigen, which has been shown to raise more potent neutralizing antibodies against RSV compared with the postfusion F antigen.
SynGEM® is able to elicit the production of Immunoglobulin A (IgA) antibodies more effectively than intramuscular injections because a higher concentration of IgA is produced in mucosal linings than all other types of antibody combined in the blood. There is evidence that IgA plays an important role in the defence against RSV in humans, making SynGEM® more effective as a vaccine against RSV.
“We are delighted that the Wellcome Trust has recognized the potential of SynGEM® to address the global health challenge of combatting RSV infections by contributing funds to this program,” said Tom Johnston, CEO of Mucosis. “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 also secured €2m additional equity financing from its current investors. These funds will enable Mucosis to complete GMP manufacturing, and to advance the Investigational Medicinal Product Dossier (IMPD) submission materials for clinical trial approval in 2016. Together with an earlier secured €5m from the Netherlands Enterprise Agency (RVO) for the development of SynGEM®, Mucosis is now in an excellent position to advance its clinical program.