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CAMBRIDGE, Mass., May 21, 2019 (GLOBE NEWSWIRE) -- ImmusanT, Inc., 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, today gave two oral presentations supporting its lead therapeutic candidate, Nexvax2®, at the Digestive Disease Week Annual Conference 2019 in San Diego. Nexvax2 is the most clinically-advanced potentially disease modifying therapeutic vaccine for people with celiac disease, currently in an ongoing global Phase 2 clinical trial.
The initial presentation, titled "Acute Gluten-Induced Symptoms in Celiac Disease (CED) are Quantitatively Correlated with Serum Cytokine Response," included the first evidence that an acute gluten challenge in celiac disease patients provokes symptoms that quantitatively correlate with increases in serum interleukin-2 (IL-2). This study found that serum IL-2 elevation is highly specific and sensitive to gluten challenge suggesting that IL-2 has diagnostic utility in celiac disease patients.
The second presentation, titled, "A Randomized, Placebo-Controlled Evaluation of the Clinical Tolerability, Pharmacodynamic (PD) & Pharmacokinetic (PK) Profiles of Subcutaneous (SC) Versus Intradermal (ID) Dosing of Nexvax2, a Peptide Treatment for Celiac Disease (CED)," details results from a Phase 1 study of Nexvax2 focusing on tolerability and the pharmacokinetics of subcutaneous (SC) versus intradermal (ID) Nexvax2 and includes data on serum IL-2 as a biomarker. Results showed that SC dosing of Nexvax2 was generally safe and well-tolerated up to doses of 900 mcg and that similar but slightly higher peptide exposure was seen with SC versus ID delivery. In addition, the SC dose-escalation regimen employed was shown to induce non-responsiveness to the high doses of gluten-derived immunogenic peptides found in Nexvax2.
"The studies presented at this year's DDW conference make a strong case, validating the ESIT platform, and demonstrating the Nexvax2 therapeutic vaccine has great potential to make a difference in the lives of celiac disease patients," said Dr. Ken Truitt, M.D., chief medical officer of ImmusanT. "For the first time, we have shown a link between elevated serum IL-2 levels and gluten exposure in people with celiac disease, and we have also shown early evidence that Nexvax2 is a safe and tolerable therapeutic vaccine with the potential to induce immune tolerance to gluten. We look forward to further validating Nexvax2 in our ongoing Phase 2 clinical trial with the hope of bringing this greatly needed new therapy to patients as soon as possible."
About ImmusanT, Inc.
At ImmusanT, we are developing a new class of therapeutic vaccines to change the lives of people living with autoimmune diseases. Our Epitope-Specific Immuno-Therapy™ (ESIT™) platform provides a precision medicine approach to restoring immune tolerance across a range of diseases, including celiac disease and type 1 diabetes. Our lead program, Nexvax2®, is in clinical development with the goal of protecting celiac disease patients against the debilitating effects of gluten. www.ImmusanT.com
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