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.