Mucosis announces pos­i­tive proof-of-con­cept data for Mimopath® plat­form in humans

Groningen, The Netherlands, 10 May 2012, Dutch vac­cine devel­op­ment com­pa­ny Mucosis B.V. today announced Phase I clin­i­cal data pro­vid­ing proof-of-con­cept that Mimopath®-based mucos­al vac­cines are safe and well tol­er­at­ed as well as able to pro­duce bal­anced immune respons­es in both cir­cu­lat­ing blood and the res­pi­ra­to­ry tract.
Mucosis, in con­junc­tion with the Centre for Human Drug Research (CHDR; Leiden, the Netherlands), con­duct­ed the clin­i­cal tri­al to assess the safe­ty, tol­er­a­bil­i­ty, and immuno­genic­i­ty of nasal­ly admin­is­tered FluGEM®, a Mimopath®-based mucos­al influen­za vac­cine con­tain­ing bac­teri­um-like par­ti­cles (BLPs) in addi­tion to a stan­dard amount of triva­lent split influen­za anti­gen. This Phase I study, which began in March of 2011, was a ran­dom­ized, blind­ed, place­bo-con­trolled study and enrolled 60 human sub­jects 18 to 49 years of age who received either stan­dard amounts of triva­lent split influen­za anti­gen or FluGEM® vac­cine con­tain­ing increas­ing dos­es of BLPs.
Nasal FluGEM® was well tol­er­at­ed with no vac­cine-relat­ed seri­ous adverse events, and the rate of over­all events was com­pa­ra­ble to that in the con­trol group. Moreover, FluGEM® induced strong hemag­glu­ti­na­tion inhi­bi­tion (HAI) anti­body respons­es against the influen­za H1N1, H3N2, and B strains. The sys­temic HAI respons­es met the sero­con­ver­sion cri­te­ria for licen­sure as out­lined in the EMA guid­ance doc­u­ment for influen­za vac­cine licen­sure, a dif­fi­cult-to-reach end­point for mucos­al vac­ci­na­tion. Seroconversion rates (i.e., per­cent­age of sub­jects with a 4-fold or high­er rise in HAI titer from base­line) ranged from 54% for H3N2, 46% for H1N1, and 50% for B strains. In addi­tion, a potent mucos­al immune response was observed in 77% of the sub­jects, as evi­denced by secre­tion of influen­za spe­cif­ic immunoglob­u­lin A mol­e­cules in the nasal cav­i­ty.
Dr. Govert Schouten, CEO of Mucosis: “We are extreme­ly pleased with the recent results of our Mimopath® proof-of-con­cept study in humans. We now look for­ward to advanc­ing our plat­form through the SynGEM™ res­pi­ra­to­ry syn­cy­tial virus and PneuGEM® pneu­mo­coc­cal vac­cine pro­grams. In these inno­v­a­tive pro­grams, we apply our core Mimopath® tech­nol­o­gy to deliv­er vac­cine anti­gens via the most rel­e­vant route of admin­is­tra­tion – the mucosa. We will fur­ther devel­op the FluGEM® vac­cine can­di­date in coop­er­a­tion with cor­po­rate, gov­ern­men­tal and non-gov­ern­men­tal part­ners. We also con­tin­ue to roll out our licens­ing pro­gram that allows part­ners to lever­age our Mimopath® tech­nol­o­gy for use in fields out­side our focus of res­pi­ra­to­ry tract infec­tions.”
Mucosis’s lead vac­cine can­di­date, 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.

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