Icon Genetics has published a first milestone paper about the successfully completed phase i clinical study of a novel norovirus vaccine

Halle (Saale), 07. Octo­ber 2022. Icon Genet­ics GmbH, a whol­ly owned sub­sidiary of Den­ka Co. Ltd, Tokyo, Japan, has suc­cess­ful­ly com­plet­ed a Phase I clin­i­cal study of its norovirus vac­cine can­di­date and pub­lished a first mile­stone paper in the renowned jour­nal “Fron­tiers in Immunol­o­gy”.

Norovirus­es are respon­si­ble for approx­i­mate­ly 20% of all cas­es of acute gas­troen­teri­tis world­wide. Despite decades of inten­sive research in the field, no licensed vac­cine for pre­vent­ing norovirus dis­ease and ame­lio­rat­ing detri­men­tal health, soci­etal, and eco­nom­ic effects in all age groups is avail­able today. There­fore, its is gen­er­al­ly rec­og­nized that devel­op­ment of an effi­ca­cious vac­cine against norovirus gas­troen­teri­tis is of para­mount impor­tance giv­en its poten­tial to reduce the glob­al bur­den of norovirus-asso­ci­at­ed mor­bid­i­ty and mor­tal­i­ty.

The report­ed tri­al was a sin­gle-cen­ter, ran­dom­ized, dou­ble-blind, con­trolled study that has been approved by the Bel­gian Health Author­i­ties (Fed­er­al Agency for Med­i­cine and Health Prod­ucts-FAMHP) and run in the Cen­ter for Vac­ci­nol­o­gy (CEVAC) at the Ghent Uni­ver­si­ty Hos­pi­tal (Ghent, Bel­gium). This first-in-human Phase I study eval­u­at­ed the safe­ty and immuno­genic­i­ty of two admin­is­tra­tions of Icon Genet­ics’ can­di­date norovirus vac­cine at two dose lev­els in healthy sub­jects aged 18 to 40 years. The norovirus vac­cine can­di­date has shown an excel­lent safe­ty pro­file and elicit­ed remark­able, long-last­ing humoral and cel­lu­lar immune respons­es desired for such a vac­cine. The mea­sured immune respons­es were on par or even exceed­ing prod­ucts in clin­i­cal devel­op­ment by com­peti­tors, despite no use of adju­vant in the for­mu­la­tion. The report­ed results ful­ly sup­port fur­ther devel­op­ment of the norovirus vac­cine can­di­date.

For its can­di­date norovirus vac­cine Icon Genet­ics pro­duces norovirus-like par­ti­cles (VLPs), that mim­ic the struc­ture of the virus but are not infec­tive, in high yield using the company’s mag­nI­CON® tech­nol­o­gy. The pro­pri­etary mag­nI­CON® tech­nol­o­gy uti­lizes tobac­co plants for the rapid, scal­able, and envi­ron­ment-friend­ly pro­duc­tion of diverse recom­bi­nant pro­teins to serve the diag­nos­tics and bio­phar­ma­ceu­ti­cals mar­kets. Unlike with old­er GMO tech­nolo­gies, Icon Genet­ics’ pro­duc­tion host plants are not genet­i­cal­ly mod­i­fied in a sta­ble man­ner but are rather tem­porar­i­ly instruct­ed to pro­duce a pro­tein of inter­est by treat­ment with a bac­te­r­i­al vec­tor car­ry­ing the genet­ic blue­print for the prod­uct. The tar­get pro­teins are pro­duced indoors and are sub­se­quent­ly extract­ed in pure form from the plants’ leaves. The norovirus vac­cine can­di­date for the cur­rent clin­i­cal study was pro­duced at Icon Genet­ics’ pilot-scale facil­i­ty in Halle/Saale, Ger­many.