Vaccines Preserved with AVANT Immunotherapeutics' VitriLife Technology Show Good Stability at Room Temperature and Above
Wednesday May 12, 8:00 am ET
NEEDHAM, Mass.--(BUSINESS WIRE)--May 12, 2004--Data to be presented by AVANT Immunotherapeutics (Nasdaq: AVAN - News) at the "Lyophilization 2004" meeting in Philadelphia show that vaccines manufactured and dried using the company's VitriLife® 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.
About AVANT
AVANT Immunotherapeutics, Inc. discovers, develops and sells innovative vaccines and therapeutics that harness the human immune system to prevent and treat disease. The company has developed a broad, well-staged pipeline of vaccines and therapeutics for large, high-value, under-served markets. Six of AVANT's products are in clinical development. These include an oral human rotavirus vaccine, a treatment to reduce complement-mediated tissue damage associated with cardiac by-pass surgery, and a novel vaccine for cholesterol management. AVANT has also assembled a technology platform that enables the creation of rapid-protecting, single-dose, oral vaccines that remain stable without refrigeration. The company is developing applications of this vaccine technology in four areas: biodefense, travelers' vaccines, global health needs, and human food safety. AVANT's goal is to demonstrate proof-of-concept for its products before leveraging further development through both traditional pharmaceutical partnerships and collaborations with governmental and other organizations.
Additional information on AVANT Immunotherapeutics, Inc. can be obtained through our site on the World Wide Web: 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", "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(TM) (Peru-15), Ty800 and other products; (4) the cost, timing, scope and results of ongoing safety and efficacy trials of TP10, CETi-1, CholeraGarde(TM) (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(TM) (Peru-15), Ty800and 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®Vac 1, Megan®Egg and other future products; (8) changes in existing and potential relationships with corporate collaborators; (9) the availability, cost, delivery and quality of clinical and commercial grade materials supplied by contract manufacturers; (10) the timing, cost and uncertainty of obtaining regulatory approvals to use TP10, CETi-1, CholeraGarde(TM) (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; (11) the ability to obtain substantial additional funding; (12) the ability to develop and commercialize products before competitors; (13) the ability to retain certain members of management; and (14) 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.
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Contact:
AVANT Immunotherapeutics, Inc.
Una S. Ryan, Ph.D., 781-433-0771
or
Avery W. Catlin, 781-433-0771
info@avantimmune.com
or
Media:
Kureczka/Martin Associates
Joan Kureczka, 415-821-2413
jkureczka@aol.com |
