ImmusanT hopes its lead candidate, celiac disease vaccine Nexvax2, can soon protect patients from accidental exposure to gluten. And it has just earned an FDA fast-track designation that promises an expedited review.
Currently in phase 2 testing in the U.S., Australia and New Zealand, Nexavax2 is designed to help celiac disease patients with the HLA-DQ2.5 immune recognition genes, who account for more than 90% of the disease’s total population.
“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,” said ImmusanT CEO Leslie Willimas in a statement.
Celiac disease happens when genetically susceptible people eat gluten-containing foods. Their bodies inappropriately initiate an immune response that causes inflammation of the small intestine and impedes the digestion of nutrients. It is estimated to affect 1 in 100 people worldwide, according to ImmusanT.
Without an approved treatment, patients need to stay away from gluten, which can be commonly found in wheat, rye and barley, as well as countless processed foods. But ImmusanT believes Nexvax2 can help patients return to a normal diet by targeting the cause of the disease. Made up of gluten peptides, the therapeutic vaccine candidate aims to train the T-cells responsible for the disease to stop triggering an autoimmune attack.
Previous phase 1 results have shown the vaccine to be safe and tolerable, and the Cambridge, Massachusetts-based company initiated phase 2 study in September 2018. The study plans to enroll about 150 celiac disease patients who will be given either Nexvax2 or a dummy injection twice weekly for 16 weeks and will be assessed for GI symptoms after a gluten food challenge.
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Besides Nexvax2, ImmusanT is developing vaccines for other HLA-associated autoimmune diseases, including Type 1 diabetes.
Meanwhile, Takeda has a celiac disease collaboration with U.S. biotech PvP Biologics. Instead of working on the patients’ immune system, PVP’s Kuma062 (KumaMax) is a recombinant enzyme that works by degrading the immune-reactive parts of gluten before they exit the stomach and enter the small intestine in order to reduce an immune response.
PVP just pushed the candidate into two phase 1 studies. If the early-phase trial turns out positive, Takeda has an option to acquire the biotech under a deal announced in early 2017.