Celiac.com 01/04/2018 - Nexvax2 is a peptide-based, epitope-specific immunotherapy intended to reduce reactions to natural gluten exposure, and ultimately restore tolerance to gluten in patients with celiac disease.
Celiac disease patients who received fixed intradermal doses of Nexvax2 lost their sensitivity to the HLA-DQ2·5-restricted gluten epitopes in Nexvax2, but their tolerance was limited to 150 μg, due to gastrointestinal symptoms and cytokine release, mimicking gluten exposure, that accompany the first dose.
A team of researchers recently set out to test whether small doses in steps might reduce the first dose effect of Nexvax2 in celiac disease patients.
The research team included James M. Daveson, Hooi C. E, Jane M. Andrews, Timothy King, Kaela E. Goldstein, John L...

Celiac.com 11/05/2018 - ImmusanT, Inc. is a clinical stage company looking to deliver innovative peptide-based immunomodulatory vaccine therapies to patients with autoimmune diseases, initiated enrollment in Australia and New Zealand for its celiac disease vaccine. Along with Nexvax2, ImmusanT is working to develop vaccines for other HLA-associated autoimmune diseases, including type 1 diabetes.
The Phase 2 trials will assess the safety, tolerability and efficacy of its celiac vaccine, Nexvax2, on celiac patients who carry the immune recognition genes for HLA-DQ2.5.  Carriers of HLA-DQ2.5 account for approximately 90% of people with disease, and Nexvax2 is designed to protect these patients from the effects of gluten exposure.
Nexvax2 is currently the only disease-modifying ...

Celiac.com 03/22/2019 - I'm going to talk about my journey through the Nexvax2 trial. It is a clinical trial to study the effectiveness of this drug to prevent mucosal damage due to cross contamination. There are 4 phases to this trial - Screening, Updosing, Maintenance, and Post-Study. Each phase has different requirements from the patient and different goals.
Screening for the Nexvax2 Clinical Trial
I found out about the Nexvax2 trial from my sister. Her job involves keeping up with medical stocks. She saw that ImmusanT had started their clinical trial - a double, blind, placebo controlled study for an injection to retrain the immune system to stop recognizing gluten as a foreign invader. It works similarly to allergy shots desensitizing the immune system to gluten. I looked...

Celiac.com 07/01/2019 - Drugmakers have pulled the plug on a phase II trial of Nexvax2, a promising drug for treating celiac disease. Pharmaceutical company ImmusanT, said that "results from an interim analysis revealed Nexvax2 did not provide statistically meaningful protection from gluten exposure for celiac disease patients when compared with placebo."
That's a lot of fancy language to say that the drug simply didn't work. It did no better than a placebo. If there were any other way to spin it, the company would have spun it. They didn't. That basically means total failure.
We've written about Nexvax2 over the years, and followed it through its development. It was promising enough to earn fast-track development status by the FDA.
The company's press release reads...