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.
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.