CAMBRIDGE, Mass.--(BUSINESS WIRE)--ImmusanT, Inc., a clinical-stage company developing Nexvax2®, a therapeutic vaccine intended to protect against the effects of gluten exposure in HLA-DQ2.5+ patients with celiac disease, today announced the results of two Phase 1 studies of Nexvax2® in patients with celiac disease. The studies were presented in an oral presentation and two poster presentations at Digestive Disease Week (DDW) 2016 in San Diego, California.
Celiac disease is an immune-mediated gastrointestinal disease caused by dietary gluten predominantly in individuals who carry the HLA-DQ2.5 immune recognition gene, and shares key pathogenic and genetic features with organ-specific autoimmune (AI) diseases. ImmusanT is developing Nexvax2®, an epitope-specific immuno-therapy (ESIT) that consists of an injectable formulation of 3 peptides with epitopes recognized by gluten-reactive CD4+ T cells to target and render these cells unresponsive to gluten.
One poster, titled “A Single Intradermal (ID) Injection of Nexvax2®, a Peptide Composition with Dominant Epitopes for Gluten-Reactive CD4+ T Cells, Activates T Cells and Triggers Acute Gastrointestinal Symptoms in HLA-DQ2.5+ People with Celiac Disease (CeD),” included data from two Phase 1b clinical trials investigating the safety, tolerability, pharmacokinetics, and mechanism of action of Nexvax2 in 82 HLA-DQ2.5+ subjects with celiac disease on a gluten-free diet. In these studies, subjects received intra-dermal administration of Nexvax2 or placebo, and cytokine and chemokine serum levels were evaluated six hours post-dose. The results demonstrated that Nexvax2 peptides were detectable in plasma shortly after administration until up to four hours post-dose and confirmed T-cell engagement within 2 hours of administration. This suggests that gluten-specific memory CD4+ T cells were activated by Nexvax2 and could be related to the clinical effects observed following gluten ingestion in patients with celiac disease.
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