Avant Immunotherapeutics

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AVAN AVANT Immunotherapeutics, Inc., incorporated in 1983, is a biopharmaceutical company that uses novel applications of immunology to develop products for the prevention and treatment of diseases. The Company is developing a portfolio of vaccines and immunotherapeutics addressing applications, including cardiovascular disease, bacterial and viral diseases, and biodefense and food safety. These include single-dose, oral vaccines that protect against important disease-causing agents, a novel vaccine candidate for cholesterol management and a treatment to reduce complement-mediated tissue damage associated with cardiac by-pass surgery. The Company's wholly owned subsidiaries are AVANT TC Merger Corp. and Virus Research Institute, Inc. (VRI).

The Company is building business franchises in three disease areas: cardiovascular diseases, including cholesterol management, bacterial vaccines and viral vaccines. Its products are derived from a set of technologies with the ability to utilize the human immune system and enable the creation of preventative and therapeutic agents.

Viral Vaccines

Rotavirus is a cause of diarrhea and vomiting in infants and children in the United States and Europe and a cause of infant mortality worldwide. The Company licensed an oral vaccine for rotavirus from a non-profit institution and initiated a Phase I clinical trial with the goal of licensing the vaccine to a major vaccine company. After completing Phase I studies and commencing a Phase II study, it licensed the vaccine to GlaxoSmithKline plc (Glaxo). Glaxo initiated Phase III global clinical trials, during the year ended December 31, 2003, of its investigational rotavirus vaccine, Rotarix, a two-dose oral rotavirus vaccine, which has been shown to be helpful in preventing rotavirus gastroenteritis disease in young children for at least two years following administration.

Complement Inhibitors

The Company is developing a class of therapeutics that inhibits the complement system, a key triggering mechanism for the body's inflammatory response. These include reperfusion injury, the vascular and tissue damage that occurs following a heart attack, stroke or surgical procedure where the patient's blood supply is shut off and then restored, hyperacute or chronic organ rejection following transplantation, acute inflammatory injury to the lungs and autoimmune diseases. The Company has developed a lead compound, TP10 for cardiac surgery. In February 2004, AVANT announced plans to start a Phase II-b, double blind, and placebo-controlled trial of TP10 in 300 women undergoing cardiopulmonary by-pass surgery. The trial will examine the effect of TP10 versus placebo and will be conducted at approximately 25 sites throughout the United States.

Cholesterol Management Vaccine

The Company is developing a treatment vaccine, CETi-1, aimed at increasing levels of high-density lipoprotein (HDL). The vaccine stimulates the production of antibodies to cholesteryl ester transfer protein (CETP), which mediates the balance between HDL and low-density lipoprotein (LDL) or bad cholesterol. AVANT completed a Phase I clinical trial and results indicated that the vaccine was well-tolerated in the 48 adult volunteers who participated in the study. The Phase I clinical study and its extension demonstrated an acceptable safety profile for the CETi-1 vaccine, as well as showed its ability to elicit antibody titers against CETP and suggested a dose-response relationship. In October 2003, AVANT completed a 200 patient placebo-controlled Phase II efficacy study of the CETi-1 vaccine in patients with low-levels of HDL cholesterol.

Bacterial Vaccines

AVANT is developing a series of single-dose, genetically attenuated, live bacterial vaccines to prevent diarrhea and dysentery. These diarrheal vaccines are targeted to address the United States and European travelers' market, as well as the healthcare requirements of developing countries. The Company is developing a single-dose, oral cholera vaccine using a live, genetically attenuated cholera strain. Based on this technology, discovered in academia, the Company has developed the vaccine through early Phase II trials. In January 2004, the Company announced positive preliminary results of the adult portion from the Phase II clinical trial of CholeraGarde in Bangladesh.

Based on the similar technology, AVANT has designed its Ty800 vaccine to offer rapid, single-dose protection against Salmonella typhi, the cause of typhoid fever. The National Institute of Allergy and Infectious Disease (the NIAID) of the National Institutes of Health (NIH) and AVANT have entered into a cooperative agreement for the NIAID to conduct a Phase I in-patient dose, ranging from clinical trial aimed at demonstrating the safety and immunogenicity of the Ty800 typhoid fever vaccine. The Company is also developing additional bacterial vaccines to prevent infection with Shigella, enterotoxigenic E. coli and Campylobacter, which are all causes of severe diarrheal illness.

The Company's competitors include Merck, Pfizer, Japan Tobacco, Alexion, Esperion, Acambis, Chiron, ID Biomedical, Iomai, MicroScience, VaxGen and Berna Biotech.

Avant Immunotherapeutics Inc
119 Fourth Avenue
Needham, MA 02494
Phone: (781) 433-0771
Fax: (781) 433-0262
Email: info@avantimmune.com
Web Site: http://www.avantimmune.com/

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