Icon Genetics clinical development of its novel norovirus vaccine reaches milestone of complete dosing of the first cohort

Halle (Saale), Octo­ber 2, 2020. Icon Genet­ics GmbH, a whol­ly owned sub­sidiary of Den­ka Co. Ltd, Tokyo, Japan, has ini­ti­at­ed a Phase I clin­i­cal study of its norovirus vac­cine can­di­date in August, 2020 and now suc­cess­ful­ly final­ized dos­ing of the first of two cohorts.

The tri­al is 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 aims at eval­u­at­ing 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.
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 is avail­able today.
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.

About Icon Genet­ics
Icon Genet­ics GmbH (Halle/Saale, Ger­many) is a world leader in devel­op­ing and using expres­sion sys­tems for pro­duc­tion of recom­bi­nant pro­teins in green plants. The com­pa­ny has estab­lished a new gen­er­a­tion pro­duc­tion plat­form, mag­nI­CON®, and holds a dom­i­nant patent port­fo­lio com­posed of over 400 grant­ed patents in the field of plant-based expres­sion sys­tems.

About the Cen­ter for Vac­ci­nol­o­gy
The Cen­ter for Vac­ci­nol­o­gy of the Ghent Uni­ver­si­ty and Uni­ver­si­ty Hos­pi­tal (CEVAC) has a large track record in doing vac­cine tri­als for numer­ous infec­tious dis­eases: hepati­tis B, com­bined hepati­tis A, B, C, influen­za, HPV, HSV, VZV, RSV, CMV, HIV, tuber­cu­lo­sis, malar­ia, for a wide num­ber of spon­sors. CEVAC has devel­oped a large port­fo­lio of assays to mea­sure humoral and cel­lu­lar immune respons­es fol­low­ing rapid blood sam­ple on-site pro­cess­ing.

About Den­ka
Den­ka head­quar­tered in Chuo-ku, Tokyo, Japan con­ducts busi­ness activ­i­ties on a glob­al scale across a wide range of fields, from inor­gan­ic and organ­ic chem­i­cals, to elec­tron­ic mate­ri­als and phar­ma­ceu­ti­cals. Found­ed in 1915, Den­ka has steadi­ly con­tin­ued to devel­op and man­u­fac­ture prod­ucts that con­tribute to the devel­op­ment of soci­ety by ful­ly uti­liz­ing its unique con­cepts and tech­no­log­i­cal capa­bil­i­ties.