Mucosis Secures €3.7M from Wellcome Trust to Fund Clinical Trials of its Respiratory Syncytial Virus Vaccine in Partnership with Imperial College London

Funding will enable new intranasal vac­cine SynGEM® to be test­ed in phase I and IIa human clin­i­cal tri­als

Groningen, the Netherlands, January 20, 2016 –Mucosis B.V., a clin­i­cal stage biotech­nol­o­gy com­pa­ny using a pro­pri­etary tech­nol­o­gy plat­form to devel­op next-gen­er­a­tion and nee­dle-free human vac­cines for infec­tious dis­eases, today 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 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 WHO1, 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.
1. WHO. 2009. Initiative for Vaccine Research (IVR). Respiratory syn­cy­tial virus and parain­fluen­za virus­es. Disease bur­den. WHO, Geneva, Switzerland.

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