AVANT and Harvard Medical School Receive NIH Funding for Production of a Thermostable Cholera Vaccine - Press Releases

AVANT and Harvard Medical School Receive NIH Funding for Production of a Thermostable Cholera Vaccine
NEEDHAM, Mass.--(BUSINESS WIRE)--July 18, 2005--AVANT Immunotherapeutics, Inc. (Nasdaq: AVAN) today announced that Harvard Medical School will receive nearly $500,000 from the National Institutes of Health (NIH) to develop a VitriLife(R) formulation of CholeraGarde(R), AVANT's single dose, oral cholera vaccine derived from the Peru-15 strain. VitriLife(R) is a proprietary technology that confers thermostability to live bacterial vaccines. As a subcontractor under Harvard Medical School's award, AVANT will receive approximately $374,000 of this funding over a twelve-month period.
The funded project will consist of optimizing manufacturing yields in the fermentation and vitrification processes and evaluating and comparing several VitriLife(R) process methods to traditional lyophilized CholeraGarde(R). It will also include a comparison of CholeraGarde(R) VitriLife(R) formulations to previously studied lyophilized formulations of the vaccine for stability, colonization and potency in animal immunogenicity studies. The project will be jointly directed by the inventor of the vaccine, John J. Mekalanos, Ph.D., Adele H. Lehman Professor of Microbiology and Molecular Genetics, Harvard Medical School, and Kevin P. Killeen, Ph.D. Senior Director, Bacterial Vaccines, at AVANT.
"We are very pleased to receive this funding from the NIH which enables us to continue the application of the VitriLife(R) technology to our bacterial vaccine portfolio," said Una S. Ryan, Ph.D., President and Chief Executive Officer of AVANT Immunotherapeutics, Inc. "Development of thermostable vaccines has been a priority for the NIH, the WHO and the Bill and Melinda Gates Foundation."
"I am particularly pleased to see this project moving forward," stated Dr. Mekalanos. "Thermostability of AVANT's CholeraGarde(R) is an important milestone to the development of an effective cholera vaccine for biodefense and global health purposes, settings where its use would be of the greatest urgency."
Freeze-dried (lyophilized) preparations of CholeraGarde(R) have been shown to be well tolerated and immunogenic in clinical studies in the United States and Bangladesh. However, freeze-dried CholeraGarde(R) is currently stored at -20 degrees C, necessitating a "cold chain" to maintain vaccine stability and potency. This is a major problem for preserving this vaccine in critical settings where it is most needed.
AVANT's VitriLife(R) technology is a new vacuum-drying process for the preservation of biological suspensions, such as proteins, enzymes, viruses, bacteria and other cells, that overcomes the need for cold storage. The VitriLife(R) process turns vaccines and other biological preparations into a stable, glass foam product without the need for freezing and it will markedly improve the preservation of CholeraGarde(R) vaccine compared to freeze-drying. VitriLife(R) formulations have retained potency for up to one year at room temperature. VitriLife(R) cuts the time and cost of this manufacturing step significantly from conventional lyophilization methods. Additionally, the use of the VitriLife(R) process increases the ease of further product processing into fine powders, thus facilitating the bulk processing and packaging of product and enhancing the ability to mix multiple vaccine powders into combination vaccines.
About CholeraGarde(R)
AVANT's CholeraGarde(R) vaccine candidate is the most advanced in a portfolio of single-dose, oral vaccines in development at AVANT, aimed at protecting against serious bacterial diseases. CholeraGarde(R) is under investigation to evaluate its use against the common O1 strain of V. cholerae. Over 400 people have been vaccinated with CholeraGarde(R) in the United States and Bangladesh. The vaccine has shown to be well tolerated, highly immunogenic and provide 100% protection against moderate and severe diarrhea in volunteers challenged with live cholera bacteria. There is currently no licensed cholera vaccine in the United States.
About AVANT Immunotherapeutics, Inc.
AVANT Immunotherapeutics, Inc. discovers and develops innovative vaccines and therapeutics that harness the human immune system to prevent and treat disease. Six of AVANT's products are in clinical development, including a treatment to reduce complement-mediated tissue damage associated with cardiac bypass surgery and a novel vaccine for cholesterol management. AVANT is also developing a pipeline of bacteria-fighting products for biodefense, travelers' vaccines, and global health needs based on AVANT'S rapid-protecting, single-dose, oral and temperature stable vaccine technology.
Additional information on AVANT Immunotherapeutics, Inc. can be obtained through our site on the World Wide Web: http://www.avantimmune.com.
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: This release includes forward-looking statements which reflect AVANT's current views with respect to future events and financial performance. These forward-looking statements are based on management's beliefs and assumptions and information currently available. The words "believe", "expect", "anticipate", AVANT and Harvard Medical School Receive NIH Funding for Production of a "intend", "estimate", "project" and similar expressions which do not relate solely to historical matters identify forward-looking statements. Investors should be cautious in relying on forward-looking statements because they are subject to a variety of risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed in any such forward-looking statements. These factors include, but are not limited to: (1) the integration of multiple technologies and programs; (2) the ability to adapt AVANT's vectoring systems to develop new, safe and effective orally administered vaccines against anthrax and plague or other bioterrorism threats or emerging health care threats; (3) the ability to successfully complete development and commercialization of TP10, CETi-1, CholeraGarde(R) (Peru-15), Ty800 and other products; (4) the cost, timing, scope and results of ongoing safety and efficacy trials of TP10, CETi-1, CholeraGarde(R) (Peru-15), Ty800 and other preclinical and clinical testing; (5) the ability to successfully complete product research and further development, including animal, pre-clinical and clinical studies of TP10, CETi-1, CholeraGarde(R) (Peru-15), Ty800 and other products; (6) the ability of the Company to manage multiple late stage clinical trials for a variety of product candidates; (7) the volume and profitability of product sales of Megan(R)Vac 1, Megan(R)Egg and other future products; (8) the process of obtaining regulatory approval for the sale of Rotarix (R) in major commercial markets, as well as the timing and success of worldwide commercialization of Rotarix (R) by our partner, GlaxoSmithKline; (9) changes in existing and potential relationships with corporate collaborators; (10) the availability, cost, delivery and quality of clinical and commercial grade materials supplied by contract manufacturers; (11) the timing, cost and uncertainty of obtaining regulatory approvals to use TP10, CETi-1, CholeraGarde(R) (Peru-15) and Ty800, among other purposes, for adults undergoing cardiac surgery, to raise serum HDL cholesterol levels and to protect travelers and people in endemic regions from diarrhea causing diseases, respectively; (12) the ability to obtain substantial additional funding; (13) the ability to develop and commercialize products before competitors; (14) the ability to retain certain members of management; and (15) other factors detailed from time to time in filings with the Securities and Exchange Commission. We expressly disclaim any responsibility to update forward-looking statements.
CONTACT: AVANT Immunotherapeutics, Inc.
Una S. Ryan, Ph.D., 781-433-0771
President and CEO
or
Avery W. Catlin, 781-433-0771
Chief Financial Officer
info@avantimmune.com
or
For Media:
Kureczka/Martin Associates
Joan Kureczka, 415-821-2413
jkureczka@comcast.net
SOURCE: AVANT Immunotherapeutics, Inc.