ImmusanT Inc., a Cambridge, MA company that is developing a vaccine that would allow people with Celiac disease to eat gluten, has received some important recognition.
Informa has named the company’s drug one of the Top 10 Autoimmune/Anti-Inflammatory Projects to Watch. That has given new energy to ImmusanT executives as they enter Phase 2 of clinical trials.
One percent of the world’s population has Celiac disease, an autoimmune disorder that triggers a defensive response to gluten.
“We believe that what we’re doing is truly game changing and will completely shift the paradigm for patients that have no option, aside from a strict gluten free diet, which is difficult,” said Leslie Williams, ImmusanT president and CEO. “We were honored, excited and quite pleased the outside sees what we’re doing as an important project.”
ImmusanT’s Nexvax2 vaccine works in Celiac patients with a certain genetic marker to reprogram the body’s T cells, which typically attack the gluten when it enters the blood stream in the small intestine. The T-cells’ reaction triggers inflammation in the small intestine, which causes damage to its lining, which is primarily is how the body absorbs nutrients.
Without the T-cells’ defensive reaction, inflammation isn’t triggered, and a Celiac would be able to eat gluten.
The company’s drug has shown promise in two rounds of Phase 1 clinical trials, which included testing on over 100 patients,. Phase 2 clinical trials, which will begin in 2015, will look to analyze the drug’s dosage, how long dosage has to continue to reprogram the body’s autoimmune response, and what the ultimate efficacy is of the drug.
The marketing potential for the drug is massive, as it is effective in patients that carry the immune recognition gene, or approximately 90 percent of the global Celiac population.
But Williams said it was too early to say when the drug might be submitted to the FDA for marketing approval. There is also no clear regulatory pathway, because the company would be the first to demonstrate renewed tolerance in an autoimmune disease.
But the promise of the drug could change the way of life for millions of Celiacs, and it could have implications for solving other autoimmune deficiencies, Williams said.
That promise is only one of the reasons the drug was selected for the Top 10 list, which includes an analysis of a number of other criteria, including the unmet medical need, market potential, partnering opportunities, potential for long-term opportunity opportunities, and corporate stability.
“As the industry leader in strategic analysis and transaction tracking, our main goal is to give these companies exposure to potential investors, partners and acquirers,” said Marc Wortman, editorial director of Informa company Therapeutic Area Partnerships
ImmusanT is also in the midst of developing a diagnostic tool, a noninvasive technique to identify Celiac patients without a small bowel biopsy.