Clinical Development / Scientific Approach
ImmusanT’s proprietary discovery platform has mapped the parts of nutritional gluten proteins that cause undesired immune activation in patients with celiac disease according to their genetic background. Similar to allergens, nutritional proteins typically do not induce an immune reaction, as the immune system is kept non-responsive to them. In susceptible individuals, the auto-immune type reaction causes inflammation and damage of the gut with corresponding symptoms that celiac disease patients are all too familiar with.
Nexvax2 is an intradermally-administered therapeutic vaccine, or epitope-specific immunotherapy (ESIT), that is designed to restore immune non-responsiveness (tolerance) to gluten. Nexvax2® is suitable for patients who carry the immune recognition genes for HLA-DQ2.5, which accounts for more than 90% of celiac disease patients. This mechanism is comparable to allergy vaccination, which is effective in treating human allergic diseases.
Nexvax2® will be the first therapy ever to demonstrate tolerance induction in an autoimmune disease. In addition, this platform has informed the development of Nexvax2® companion and standalone diagnostics, which aim to provide precise and informative results for the diagnosis and monitoring of celiac disease.