Start-Up ImmusanT Seeks to Restore Tolerance to Gluten in Celiac Disease with Immunotherapy

CAMBRIDGE, Mass., March 15, 2011 /PRNewswire/ -- Biotechnology company ImmusanT, Inc. today announced it has established its operations in Cambridge, Massachusetts and is advancing its strategy to develop an immunotherapeutic vaccine, companion diagnostic and monitoring tool for celiac disease. The company completed the acquisition of a discovery platform for targeted immunotherapies from Nexpep Pty., Ltd., based in Melbourne, Australia, and secured seed financing from angel investors to advance its product pipeline to address the rapidly escalating number of patients diagnosed with celiac disease, a lifelong autoimmune disorder that is triggered by foods containing gluten, the main protein in wheat, rye and barley.

ImmusanT is focused on restoring tolerance to gluten in celiac disease by harnessing discoveries in immunology that improve diagnosis and treatment and return patients to a normal diet, good health and improved quality of life. ImmusanT's product pipeline includes Nexvax2®, a therapeutic vaccine that combines three proprietary peptides that elicit an immune response in patients with celiac disease who carry the immune recognition gene HLA-DQ2. ImmusanT Scientific Founder and Chief Scientific and Medical Officer Dr. Bob Anderson discovered the three primary peptides responsible for making gluten toxic to people with celiac disease. Safety, tolerability and bioactivity of Nexvax2 have been established in a Phase 1 clinical study completed last year and the therapeutic vaccine is ready to advance to a Phase 2a clinical trial, expected to begin in the next twelve months. Data from the Phase 1 study will be presented at Digestive Disease Week in Chicago, May 7-10, 2011.

"Celiac disease is the first human immune disease for which there is comprehensive understanding of the pathogenic T-cell response. We have a solid scientific foundation from which to develop the Nexvax2 immunotherapy, as well as a companion diagnostic and monitoring test for celiac disease, which have the potential to dramatically improve management of this lifelong disease," said Bob Anderson, PhD, MBChB, a gastroenterologist and highly respected international expert in immunology and clinical management of celiac disease at The Walter and Eliza Hall Institute of Medical Research.

Nexvax2 is delivered intradermally in small doses to reprogram and desensitize the disease-causing T-cells triggered by the patient's immune response to gluten. The approach is similar to treatments for allergies to cats, ragweed or dust mites, whereby repeated doses establish non-responsiveness to a specific antigen, and in the case of celiac disease, reduces or eliminates the body's rejection of dietary gluten. By reprogramming the T-cell response, the Nexvax2 approach is designed to reduce inflammation in the villi which line the small intestine and are responsible for absorbing nutrients. This returns the intestine to a normal healthy state.

Leveraging ImmusanT's proprietary peptide technology, the company has a commercial agreement with INOVA Diagnostics to develop improved serology diagnostic screening tests for celiac disease. In addition to using existing blood tests, currently the disease is diagnosed by a gastroenterologist using an endoscopic biopsy to take multiple tissue samples from the small intestine. In parallel, ImmusanT is developing a novel, simple whole-blood ELISA companion test to measure the activity of T-cells causing celiac disease and monitor optimal maintenance of immune tolerance with Nexvax2. Both diagnostic approaches may eliminate the need for an invasive surgical biopsy.

"With the formation of ImmusanT in Cambridge, we will have broad access to resources, capital and potential partners required to advance development of Nexvax2 and our companion diagnostics," said Leslie J. Williams, founder, president and chief executive officer of ImmusanT, Inc. "ImmusanT's near-term opportunity is to provide a novel treatment to address the high unmet need and untapped growing market of celiac disease. Longer-term we will exploit our discovery platform to identify other autoimmune diseases, such as Type 1 diabetes and irritable bowel syndrome, where diagnosis and treatment could be improved using our targeted approach."

Ms. Williams has extensive experience with emerging biotechnology companies and was most recently president and chief executive officer of Ventaira Pharmaceuticals. She was a senior marketing strategist for INO Therapeutics and gained drug-delivery and drug-monitoring experience at Datex-Ohmeda (formerly Ohmeda). Ms. Williams' prior pharmaceutical industry experience includes commercial positions at Merck and GlaxoSmithKline. As a Battelle Ventures venture partner, Ms. Williams assisted early-stage technology companies with strategy, management and business development. She mentors early-stage entrepreneurs and serves as a director of Hepregen Corp, CDI Bioscience and The Capital Network. Ms. Williams holds an MBA from Washington University and a BS degree with honors in nursing from the University of Iowa. Before entering industry, she was a critical-care nurse at Duke University, Medical College of Virginia and at the University of Iowa.

About Celiac Disease

Celiac disease is an inherited autoimmune disorder that affects the digestive process of the small intestine. When a person who has celiac disease consumes gluten, a protein found in wheat, rye and barley, the individual's immune system responds by triggering T-cells to fight the offending proteins, damaging the small intestine and inhibiting the absorption of important nutrients into the body. With no available drug therapy, the only option for the approximately 1% of the global population that has celiac disease is to eliminate gluten from the diet. Compliance is often challenging and nearly half the people on the strict elimination diet still have residual damage to their small intestine.

Undiagnosed, celiac disease is a major contributor to poor educational performance and failure to thrive in children. Untreated disease in adults is associated with increased risk of fractures and osteoporosis, problems during pregnancy and birth, short stature, dental enamel hypoplasia, dermatitis, recurrent stomatitis and cancer.

About ImmusanT, Inc.

ImmusanT is a privately-held biotechnology company focused on restoring tolerance to gluten in celiac disease by harnessing new discoveries in immunology that improve diagnosis and treatment and return patients to a normal diet, good health and improved quality of life. The company's Nexvax2® therapeutic vaccine for celiac disease is preparing to advance to Phase 2a clinical trials. ImmusanT is simultaneously developing a companion diagnostic and monitoring tool to improve celiac disease management. Its targeted immunotherapy discovery platform may have additional applications for a variety of epitope-specific autoimmune diseases. More information can be found at www.ImmusanT.com.

SOURCE ImmusanT, Inc.