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 June 28, 2010 - Avaxia Biologics Receives Massachusetts Life Sciences Center Funding to Develop Oral Antibody Therapeutics for Oral Mucositis, Inflammatory Bowel Disease, Diabetes and Obesity

Avaxia Biologics, Inc., a biotechnology company developing oral antibodies for diseases of the GI tract, announced today that it is one of four early-stage life science companies to receive an Accelerator Program loan from the Massachusetts Life Sciences Center (MLSC). MLSC, a quasi-public agency tasked with implementing the state's ten-year, $1 billion Life Sciences Initiative, announced that Avaxia Biologics was authorized to receive $375,000 to continue product development and file new patents for its orally delivered antibody therapeutics aimed at disease targets accessible through the mouth and gastrointestinal (GI) tract.

"We are delighted to have been awarded this loan from the MLSC," said Barbara S. Fox, Ph.D., Avaxia's founder and CEO. "The support of the MLSC provides the funding we need to accelerate the development of our therapeutic programs and to advance the building of a strong intellectual property portfolio to support these drug products."

Dr. Fox continued, "We are pleased that the MLSC has recognized the potential therapeutic opportunities our approach brings to areas of unmet medical needs and Avaxia welcomes this validation of our programs. The GI tract is a uniquely privileged space that has been previously inaccessible to monoclonal antibody therapy. Avaxia's lead products are antibodies that are stable in the GI tract and are targeted at oral mucositis, inflammatory bowel disease, diabetes and obesity. We believe our approach will expand upon the proven utility of antibody therapeutics and open a new chapter in human therapeutics."

ABOUT AVAXIA BIOLOGICS, INC. Avaxia Biologics (www.avaxiabiologics.com) is a private, early stage company developing orally-delivered antibody therapeutics using a proprietary antibody platform. The company is pursuing products for oral mucositis, inflammatory bowel disease, and diabetes and obesity.

Avaxia's lead product is a proprietary anti-TNF antibody to be administered to the oral cavity of patients suffering from mucositis. The antibody is designed to reduce the pain and ulceration associated with this serious side effect of cancer treatment. Avaxia is also developing a proprietary anti-TNF antibody to be administered orally to patients suffering from inflammatory bowel disease. Avaxia is also conducting discovery programs in the field of diabetes and obesity, targeting critical intestinal receptors associated with glucose metabolism.

The company has its corporate offices in Burlington, MA and its research laboratories in Watertown, MA.

ABOUT THE MASSACHUSETTS LIFE SCIENCES CENTER The Massachusetts Life Sciences Center ("the Center") is a quasi-public agency of the Commonwealth of Massachusetts tasked with implementing the Massachusetts Life Sciences Act, a ten-year, $1 billion initiative that was signed into law in June of 2008. The Center's mission is to create jobs in the life sciences and support vital scientific research that will improve the human condition. This work includes making financial investments in public and private institutions that are advancing life sciences research, development and commercialization as well as building ties between sectors of the Massachusetts life sciences community. For more information, visit www.masslifesciences.com.

 April 1, 2010 - Avaxia Biologics Awarded Phase I SBIR Grant to Develop Antibody Therapeutic for Inflammatory Bowel Disease

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.

 February 4, 2010 - David Poorvin, Ph.D. named Chief Business Officer

Avaxia Biologics, Inc., a private biotech company developing oral antibody products for disease targets that can be reached through the mouth and the gastrointestinal tract, today announced the appointment of David Poorvin, Ph.D., as Chief Business Officer.  In this position, Dr. Poorvin will be responsible for leading the Company's business development activities.

"David brings more than 35 years of business development and drug development research in the biotechnology and pharmaceutical industry,” said Avaxia Chief Executive Officer Barbara Fox, Ph.D.  “His successful record of alliance creation and new product development makes him uniquely qualified to help Avaxia build into the future.”

From 2004 to present, Dr. Poorvin served as an Executive-in-Residence at Oxford Bioscience Partners, a biotechnology venture capital firm.  Prior to joining Oxford Bioscience Partners, Dr. Poorvin worked at Schering-Plough for 22 years, the last 10 as head of Business Development.  Dr. Poorvin had also held positions of Director of Clinical Research at Schering-Plough and at Pfizer Pharmaceuticals. He was responsible for several NDA programs and product approvals at both companies, including such drugs as Procardia and Imdur. Poorvin started his career in the pharmaceutical industry at Lederle Laboratories, were he directed pre-clinical research in the cardiovascular area.

Dr. Poorvin received his B.A. degree from Hunter College of the City University of New York. He received his Ph.D. from Rutgers University where he subsequently was awarded a post-doctoral fellowship in cardiovascular research. Dr. Poorvin is a member of several professional organizations, including the Licensing Executive Society.  Dr. Poorvin currently sits on the board of directors of several biotech companies.

ABOUT AVAXIA BIOLOGICS, INC. Avaxia Biologics (www.avaxiabiologics.com) is developing oral antibody products for diseases and disease targets that can be reached through the mouth and the gastrointestinal tract. Avaxia’s products are bovine polyclonal antibodies, isolated from the early milk of immunized cows. Nature has designed these antibodies to be both stable to gastric digestion and safe for oral consumption.  The company has built a proprietary technology platform on this natural source of antibodies, with unique advantages in product safety, cost and convenience. Just as importantly, the platform offers more rapid clinical development at a greatly reduced cost. Avaxia is using the platform technology to develop medications to treat serious diseases, many of them currently untreated by existing technologies.

 September 16, 2009

Avaxia Biologics, Inc., a biotechnology company developing oral antibodies for disease targets accessible via the GI tract, announced today that it has been awarded a Phase I SBIR grant from the National Institute of Dental and Craniofacial Research to support the development of a novel antibody therapeutic for oral mucositis.

Avaxia is developing a polyclonal anti-TNF antibody to be administered to the oral cavity of patients suffering from mucositis. The antibody is designed to reduce the pain and ulceration associated with this serious side effect of cancer treatment. The grant will fund key pre-clinical studies of the antibody in a well-established animal model of radiation-induced oral mucositis.

"We are delighted to have been awarded this grant from the NIH," said Barbara S. Fox, Avaxia's founder and CEO. "Our preliminary data indicate that an anti-TNF antibody, delivered topically to a damaged mucosal membrane, will limit the severity of the inflammatory response induced by ionizing radiation. The support of the NIH provides both the funding we need to advance the development of this much needed therapeutic, and critical scientific validation of our approach."

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 toxicities associated with chemotherapy and radiation therapy used for the treatment of cancer and is a world leader in the study of cancer treatment-related mucosal injury (mucositis) .

"We are looking forward to working closely with Avaxia Biologics scientists in developing and testing a drug that could lead to an effective therapy for oral mucositis, a debilitating side effect that impacts virtually every patient who undergoes aggressive cancer treatment," said Edward Fey, managing partner of Biomodels.

Avaxia and Biomodels anticipate extending their productive collaboration to other therapeutic areas, including inflammatory bowel disease and GI enteritis and fibrosis.

ABOUT ORAL MUCOSITIS. Oral mucositis is a serious side effect of cancer chemotherapy and radiation therapy. According to a 2008 report from the National Comprehensive Cancer Network, mucositis has "emerged as the most significant adverse symptom of cancer therapy reported by patients." Mucositis is associated with severe pain and risk of infection, necessitating the use of systemic narcotics and the insertion of a feeding tube to provide nutrition. Most significantly, when mucositis develops, the dose and frequency of cancer treatment is often reduced, leading to a significant decrease in both short-term efficacy and long-term disease-free survival. There are no approved medications for the treatment of mucositis associated with most forms of cancer treatment.

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.

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AVAXIA BIOLOGICS

Avaxia's lead product is designed to treat oral mucositis, the painful inflammation and ulceration in the mouth caused by cancer chemotherapy and radiation therapy.


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