Avaxia Biologics Awarded Phase I SBIR Grant to Develop Antibody Therapeutic for Inflammatory Bowel Disease Collaboration with Biomodels facilitates development of novel drug product
Burlington, MA – April 1, 2010
Avaxia Biologics, Inc., a biotechnology company developing oral antibodies for diseases of the GI tract, announced today that it has been awarded a Phase I Small Business Innovation Research grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health, to support the development of a novel antibody therapeutic for inflammatory bowel disease (IBD). This Phase I award provides Avaxia with approximately $213,000 in research and development funds. If early results are promising, the Company could receive an additional $750,000 in Phase II funding.
Avaxia is developing a proprietary anti-TNF antibody to be administered orally to patients suffering from IBD. IBD is a chronic inflammatory disorder of the gastrointestinal tract. There are two types of inflammatory bowel disease: Crohn’s disease, primarily affecting the small intestine; and, ulcerative colitis, affecting only the colon. Approximately 1 million people in the U.S. suffer from IBD. Currently marketed parenteral anti-TNF antibodies are highly effective in treating both Crohn’s disease and ulcerative colitis; however, because they are delivered by injection they neutralize TNF throughout the body and their use is associated with serious side effects, including the reactivation of tuberculosis and a long-term risk of malignancy. Avaxia’s approach will develop an anti-TNF antibody that has a lower risk of systemic immunosuppression and can be used as a first-line therapy for inflammatory bowel disease. The grant Avaxia just received will fund key pre-clinical studies of the antibody in a well-established animal model of IBD.
"We are delighted to have been awarded this grant from the NIH," said Barbara S. Fox, Ph.D., Avaxia's founder and CEO. "Our preliminary in vivo animal data indicates that AVX-470, our orally active anti-TNF antibody, protects the intestinal lining from the damaging effects of radiation. This support from the NIH now provides the funding we need to advance the development of this antibody into pre-clinical models of IBD."
Avaxia is carrying out the grant-funded research in collaboration with Biomodels LLC, a Watertown-based pre-clinical drug research organization. Biomodels specializes in animal models of gastrointestinal diseases, such as IBD. "We are looking forward to working closely with Avaxia Biologics scientists in developing and testing a drug that could lead to an orally effective therapy for IBD," said Edward Fey, managing partner of Biomodels.
ABOUT IBD. IBD is associated with significant personal and societal costs. The primary symptoms of both Crohn’s disease and ulcerative colitis are abdominal pain, diarrhea and bleeding. IBD typically presents at a young age, and most patients require lifelong therapy. Chronic drug therapy, hospitalization, and surgery are common and are associated with significant morbidity. Approximately 1 million people in the U.S. suffer from IBD, with the prevalence equally divided between Crohn’s disease and ulcerative colitis. A study carried out in the early 1990s estimated the direct and indirect economic burden of IBD at $1.8 - $2.6 billion per year.
ABOUT AVAXIA BIOLOGICS, INC. Avaxia Biologics (www.avaxiabiologics.com) is an early stage company developing orally-delivered antibody therapeutics. The antibodies are designed to treat both diseases of the GI tract and systemic diseases where the disease targets are accessible in the GI tract. Avaxia has a proprietary antibody platform and is developing products for oral mucositis, inflammatory bowel disease, and diabetes and obesity.
ABOUT BIOMODELS LLC. Biomodels (www.biomodels.com), a preclinical drug research organization founded in 1997, develops and conducts predictive translational studies for biotechnology and pharmaceutical companies, particularly in the areas of cancer, cancer supportive care, radiation therapy, and inflammatory diseases. The company specializes in (non-GLP) efficacy studies that optimize dose, schedule and define mechanism of action. The company also has particular expertise in modeling inflammatory diseases, including those conditions affecting the gastrointestinal tract. Biomodels' studies enable organizations to more readily identify lead compounds, decrease the time to a clinical trial and increase the chance of clinical success. Biomodels is headquartered in Watertown, MA.
