Over the past 20 years researchers have learned celiac disease is more common than previously thought and is linked strongly to genetic factors. This new knowledge led to the development of two theories--a vaccine for celiac disease can be created, and it could become a big seller.

ImmusanT is putting these theories to the test. The Cambridge, MA-based startup expects to publish data from two Phase Ib trials of its celiac disease vaccine, NexVax2, in the next few months. A representative for ImmusanT told FierceVaccines the trials are designed to "demonstrate safety and tolerability, refine readouts and determine dose range and regimen."

NexVax2 is based on research ImmusanT's chief scientific officer Bob Anderson published in 2000 while at the University of Oxford. The paper identified peptides that spark an immune response in patients with the most common genetic form of celiac disease. By injecting patients with synthetic versions of three immune-triggering gluten fragments, ImmusanT hopes to free people with celiac disease from dietary restrictions.

"[The vaccine] switches off disease-causing T cells and induces clinical tolerance. It resets the way the body responds immunologically," ImmusanT CEO Leslie Williams told Xconomy. If successful, the vaccine will stop the autoimmune response that inflames the intestines of people with celiac disease.

Drug developers were slow to move into celiac disease, but interest in the sector has picked up over the past decade. Shire ($SHPG) partnered with Alba Therapeutics back in 2007, and AbbVie ($ABBV) joined the race last year when it teamed up with Alvine Pharmaceuticals. Both collaborations are more advanced than ImmusanT's candidate, but Williams thinks the vaccine approach could prove more convenient for patient.

With celiac disease affecting an estimated 3 million people in the U.S., there is also a decent-sized market to share. In 2009 Datamonitor tipped the celiac market to grow to $8 billion by 2019, but the same report also thought a drug could be on the market within 5 years. It is now 5 years since Datamonitor made the prediction and the leading candidates are yet to advance into Phase III. Alba reported Phase IIb data last month and Alvine is at a similar stage of development.

- here's the Xconomy article

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