Celiac Disease Vaccine Candidate Granted FDA Fast Track

ImmusanT Nexvax2 protects celiac disease patients who carry the HLA-DQ2.5 immune recognition genes from inadvertent gluten exposure

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The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the celiac disease therapeutic vaccine candidate, Nexvax2. 

This is important news since celiac disease is estimated to affect 1 in 100 people worldwide. Two and one-half million Americans are undiagnosed and are at risk for long-term health complications, according to Celiac.org.   

The Nexvax2 vaccine consists of a proprietary combination of three, short peptides that represent the gluten-derived immune-activating epitopes in HLA-DQ2.5+ patients. 

Nexvax2 is an epitope-specific immunotherapy, a class of therapeutic vaccine, that reprograms the T cells responsible for celiac disease to stop triggering a pro-inflammatory response. 

Nexvax2 is being developed by ImmusanT Inc. to protect celiac disease (CeD) patients who carry the HLA-DQ2.5 immune recognition genes, from inadvertent gluten exposure. 

Leslie Williams, chief executive officer for ImmusanT said in a press release, "Currently, there are no disease-modifying therapies for this condition. Our hope is that by helping restore immune tolerance towards gluten, Nexvax2 will improve quality of life and prevent the serious complications of chronic gluten exposure in celiac disease patients." 

Patients with HLA-DQ2.5 genes account for more than 90 percent of the CeD population. 

HLA genes represent the main risk factor in autoimmune disorders reported a recent study.  

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The FDA grants fast-track status to certain investigational drugs to expedite the development and/or review process for therapeutic candidates with the potential to fulfill the unmet needs of patients with serious or life-threatening conditions. 

Administered as a subcutaneous injection, Nexvax2 has completed multiple Phase 1b clinical trials, which yielded data supporting safety and tolerability as well as proof-of-mechanism and effectiveness. 

A global Phase 2 study assessing Nexvax2 is currently recruiting patients.   

ImmusanT’s Phase 2 RESET trial is a randomized, double-blind, placebo-controlled study in HLA-DQ2.5+ adults with CeD to assess the effect of Nexvax2 on symptoms after masked gluten food challenge. The trial intends to enroll approximately 150 patients across the U.S., Australia and New Zealand. 

Celiac disease is a serious autoimmune disorder that can occur in genetically predisposed people where the ingestion of gluten leads to damage in the small intestine, says Celiac.org

ImmusanT is a clinical-stage company leveraging its Epitope-Specific Immuno-Therapy™ (ESIT™) platform to deliver first-in-class peptide-based immunomodulatory vaccine therapies to patients with autoimmune diseases.