Mucosis Initiates First-in-Human Study of SynGEM®, a Needle-Free Nasal Spray RSV Vaccine

– Respiratory Syncytial Virus (RSV), a com­mon con­ta­gious lung infec­tion, is a glob­al health threat respon­si­ble for up to 200,000 deaths world­wide annu­al­ly
– UK Phase I tri­al sup­port­ed with EUR 3.44 m from Wellcome Trust, tak­ing place at Imperial College, London

Groningen, the Netherlands, November 7, 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 announces the start of a first-in-human study of its intranasal Respiratory Syncytial Virus (RSV) vac­cine can­di­date, SynGEM®, at Imperial College London’s Clinical Research Facility.
The first tri­al will recruit 48 healthy adults (36 vac­ci­nat­ed, 12 place­bo) to assess the safe­ty and immuno­genic­i­ty of a prime-boost regime of two dif­fer­ent intranasal dos­es of SynGEM®, in a ran­domised, dou­ble-blind Phase I study. Phase I is com­plet­ed at day 180 post prime vac­cine admin­is­tra­tion, with inter­im data read­out expect­ed in the first half of 2017. Phase II, due to start mid-2017, will recruit 108 adults (54 vac­ci­nat­ed, 54 place­bo).

SynGEM® is based on a unique pre­fu­sion ver­sion of the F sub­unit of RSV, shown to raise more potent serum neu­tral­iz­ing anti­bod­ies against RSV com­pared with the post­fu­sion F anti­gen approach oth­ers have used. Delivered via the mucous mem­branes in the nose, the Mucosis vac­cine can­di­date is also able to recruit anti­bod­ies pro­duced in the mucos­al lin­ings of the body, with the poten­tial to effec­tive­ly stop the virus from enter­ing the body via the mucos­al path­ways, where over 90% of pathogens enter the body. SynGEM® is based on Mucosis’ patent­ed Mimopath® tech­nol­o­gy, which uses bac­teri­um-like par­ti­cles (BLP) derived from food-grade bac­te­ria, to deliv­er the anti­gen in a more nat­ur­al con­for­ma­tion and boost the body’s immune response to the virus.
RSV is a com­mon con­ta­gious infec­tion of the lungs and res­pi­ra­to­ry path­ways, elic­it­ing cold-like symp­toms in adults. Whilst RSV infec­tion is nor­mal­ly mild in healthy adults, the infec­tion can lead to seri­ous and some­times fatal dis­eases such as pneu­mo­nia and bron­chi­oli­tis, most often in sus­cep­ti­ble pop­u­la­tions such as the young and elder­ly. Every year in the US, RSV infec­tions lead to 57,527 hos­pi­tal­i­sa­tions of chil­dren under 5 year’s old1 and are respon­si­ble for up to 200,000 deaths annu­al­ly worldwide2.

Professor Peter Openshaw, Professor of Experimental Medicine at Imperial College London and Physician in the Department of Respiratory Medicine at Imperial College Healthcare NHS Trust, “We are delight­ed to work with Mucosis on SynGEM®, a nee­dle-free nasal spray vac­cine that that is designed to raise not only sys­temic but also mucos­al immu­ni­ty at the site of entry of the virus. We will first test whether the vac­cine induces the right sort of immu­ni­ty in humans, and, if it does, then test whether it will pre­vent infec­tion in adult vol­un­teers. Previous research has shown that boost­ing immu­ni­ty in the nose and lungs may be the best way of increas­ing defence against RSV, block­ing the virus from gain­ing entry to the body.

The start of this first-in-human study marks an impor­tant mile­stone in our progress towards a nee­dle-free vac­cine for pre­ven­tion of RSV, a glob­al health threat for which there is still no vac­cine” said Tom Johnston, CEO of Mucosis. “We are pleased to be work­ing with the sup­port of the Wellcome Trust and a world-renowned uni­ver­si­ty for this next step in the pro­gram, enabling us to take advan­tage of lead­ing experts in the RSV field, and ded­i­cat­ed res­pi­ra­to­ry facil­i­ties. This sec­ond human tri­al of our Mimopath® plat­form builds on the suc­cess­ful proof of con­cept tri­al in influen­za in 2012.
The Wellcome Trust award­ed Mucosis with a €3.44 mil­lion (£2.77 mil­lion) trans­la­tion­al fund ear­li­er in the year to progress SynGEM® into phase I and IIa human clin­i­cal tri­als. On com­ple­tion of the phase I study, a phase IIa study will involve a live viral chal­lenge to assess the effi­ca­cy of SynGEM against RSV.
Details of the study can be found at www.rsvstudy.org

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