Mucosis announces pub­li­ca­tion of data demon­strat­ing safe­ty and pro­tec­tion by mucos­al­ly admin­is­tered Mimopath®-based pre­fu­sion-like F RSV vac­cines

Groningen, the Netherlands, Aug 12, 2013 – Biotechnology com­pa­ny Mucosis B.V. today announced the pub­li­ca­tion in the peer-reviewed jour­nal PLOS ONE of pre­clin­i­cal data show­ing that its inno­v­a­tive SynGEM® is safe and pro­tec­tive in ani­mal mod­els. According to the report, SynGEM®, a vac­cine based on the Mimopath® vac­cine tech­nol­o­gy allows pre­sen­ta­tion of a sta­ble pre­fu­sion-like trimer­ic F pro­tein, a fea­ture con­sid­ered impor­tant for the induc­tion of func­tion­al immu­ni­ty. Intranasally admin­is­trat­ed SynGEM® induced local­ly secret­ed IgA in the mucos­al lay­ers in addi­tion to robust lev­els of sys­temic virus neu­tral­iz­ing anti­bod­ies both in mice and cot­ton rats.
The response upon vac­ci­na­tion was ful­ly pro­tec­tive in both ani­mal mod­els while no “enhanced dis­ease” symp­toms were induced, which were clear­ly observed with the for­ma­lin-inac­ti­vat­ed RSV vac­cine that failed in clin­i­cal tri­als in the 1960s. The pre­clin­i­cal results fol­low recent devel­op­ments in RSV vac­cine research that revealed a new­ly iden­ti­fied site of vul­ner­a­bil­i­ty which is only exposed in the pre­fu­sion F pro­tein, named anti­genic site φ. This piv­otal anti­genic site is an essen­tial epi­tope required for effec­tive induc­tion of high­ly potent neu­tral­iz­ing anti­bod­ies in humans.
Dr. Kees Leenhouts, CSO of Mucosis: “Together with our part­ner at the University of Utrecht, a team led by Prof. Peter Rottier and Dr. Xander de Haan, we have suc­ceed­ed in pro­duc­ing sta­ble pre­fu­sion-like F anti­gen and for­mu­lat­ing a vac­cine can­di­date, SynGEM® that presents the pre­fu­sion F epi­topes of anti­genic site φ in a safe way to the immune sys­tem. In addi­tion, our vac­cine presents the pro­tec­tive epi­tope rec­og­nized by palivizum­ab. The intranasal appli­ca­tion poten­tial­ly results in an extra line of defense at the port of entry of the virus, which may also reduce virus shed­ding and hence may increase “herd” immu­ni­ty. The vac­cine can­di­date is there­fore unique­ly posi­tioned to fill the gap of sub­stan­tial unmet med­ical need by pre­vent­ing RSV infec­tions in peo­ple of all ages includ­ing those with the high­est mor­bid­i­ty and mor­tal­i­ty rates in the very young and elder­ly. Additionally, the non-inva­sive char­ac­ter of the vac­cine can­di­date and the Generally Recognized as Safe (GRAS) nature of the core Mimopath® vac­cine tech­nol­o­gy may lead to a greater accep­tance of mater­nal vac­ci­na­tion strate­gies in order to pro­tect pre­ma­ture new­borns and infants through pla­cen­tal and/or breast milk trans­fer of anti­bod­ies”.
“These pos­i­tive ani­mal data show­ing safe and effec­tive pro­tec­tion against RSV pro­vide fur­ther con­fir­ma­tion that the Mimopath® vac­cine plat­form will play a key role in meet­ing sig­nif­i­cant unmet med­ical need around the globe,” added Thomas S Johnston, Chief Executive Officer. “We remain focused on advanc­ing the SynGEM® pro­gram into human tri­als, as we believe its unique pre­fu­sion-like struc­ture offers the most com­plete approach to gen­er­at­ing a mean­ing­ful immune response and there­by con­fer­ring pro­tec­tion in those that need it the most.”
Mucosis is focused on the devel­op­ment the SynGEM® vac­cine can­di­date in coop­er­a­tion with its cor­po­rate,
gov­ern­men­tal and non-gov­ern­men­tal part­ners. SynGEM® is designed to pre­vent infec­tions with
Respiratory Syncytial Virus (RSV), which affect over 60 mil­lion peo­ple world­wide rang­ing from the very
young to the elder­ly with more than one mil­lion hos­pi­tal­iza­tions annu­al­ly. An RSV vac­cine does not yet
exist.
For fur­ther infor­ma­tion please con­tact:
Thomas Johnston
CEO Mucosis
+31 (50) 8200050
info@mucosis.com
www.mucosis.com

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