Vaccines Preserved with AVANT Immunotherapeutics' VitriLife Technology Show Good Stability at Room Temperature and Above - Press Releases

NEEDHAM, Mass.--(BUSINESS WIRE)--May 12, 2004--Data to be presented by AVANT Immunotherapeutics (Nasdaq: AVAN) at the "Lyophilization 2004" meeting in Philadelphia show that vaccines manufactured and dried using the company's VitriLife(R) preservation technology remain stable and immunogenic even when stored at or above normal room temperatures.
"We are now scaling up the VitriLife technology for commercial use and preparing to transfer this technology to our new Fall River manufacturing facility, where we will soon begin build-out," said Una S. Ryan, Ph.D., AVANT President and Chief Executive Officer. "That facility will implement the VitriLife process for all of AVANT's vaccines, including our oral anthrax-plague vaccine under development for the U.S. Department of Defense. We also expect this capability will provide partnering opportunities for AVANT, as we further apply VitriLife to other companies' vaccines."
VitriLife is a patented method for the industrial scale preservation of biological suspensions, such as proteins enzymes, viruses, bacteria and other cells. This method uses a drying technology to encase these biological materials in a glass-like carbohydrate coating that enables their stable storage and transportation without refrigeration. VitriLife is a gentle manufacturing process that is a simpler alternative to conventional freeze-drying (lyophilization) of vaccines or other products, cutting the time and cost of this manufacturing step significantly from conventional methods while increasing final product yields. Additionally, the use of the VitriLife 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.
"The VitriLife technology is a cornerstone of AVANT's efforts to create a new generation of "ideal" vaccines that are rapid-acting, oral, single-dose and can be shipped and stored without the need for refrigeration," said AVANT scientist Russell A. Hammond, Ph.D. "The data presented here today with four of the live attenuated bacterial strains used by AVANT in its oral vaccines show that vaccines manufactured and dried using VitriLife maintain their viability even when stored for months at elevated temperatures. Moreover, a VitriLife-preserved version of a model plague oral vaccine elicited immunogenicity in mice that was comparable to that achieved using a conventionally manufactured and frozen version of the same vaccine organism."
Dr. Hammond presented data on the use of VitriLife technology to preserve the Peru-15 Vibrio cholera, Ty800 Salmonella typhi, and the LH430 Salmonella typhimurium live attenuated bacterial strains. These organisms comprise the company's CholeraGuard(TM) cholera vaccine, Ty800 typhoid fever vaccine, and SalmoVec(TM) vaccine vector respectively. Results showed that each of the VitriLife-preserved organisms remained stably viable when stored at 25 degrees C/77 degrees F and 37 degrees C/100 degrees F for over 150 days.
Dr. Hammond also presented data on the use of VitriLife to preserve M020, a live attenuated Salmonella typhimurium strain expressing the F1-V fusion antigen from Yersinia pestis, the bacterium that causes plague. Results showed the feasibility of using VitriLife for bulk drying of the plague vaccine construct. Moreover, when tested in mice, the VitriLife vaccine elicited antibody titers against plague antigens comparable to those elicited by a version of the same vaccine preserved by freezing.