Celiac Disease Vaccine Candidate Nexvax2 Shows Promise

A clinical stage, immunotherapy company presented 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). 

The oral presentation, titled "Acute Gluten-Induced Symptoms in Celiac Disease are Quantitatively Correlated with Serum Cytokine Response," at the Digestive Disease Week (DDW) conference in San Diego, CA, on May 21, 2019, included supporting information regarding the Nexvax2 therapeutic vaccine candidate’s progress. 

Nexvax2 is potentially a disease-modifying therapeutic vaccine for people with celiac disease, currently in an ongoing global Phase 2 clinical trial, which was last updated on March 19, 2019.   

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This study found that serum IL-2 elevation is highly specific and sensitive to gluten challenge, which suggests that IL-2 has diagnostic utility in celiac disease patients. 

"This study makes a strong case 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, Inc., in a press release. 

“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.” 

This is important news since celiac disease is estimated to affect 1 percent of people worldwide. 

Moreover, 2.5 million Americans are undiagnosed and are at risk for long-term health complications, according to Celiac.org. 

Previously, during January 2019, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to Nexvax2. 

"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."

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