PharmAthene, Inc., a biodefense company developing medical countermeasures against biological and chemical threats, announced today that it continues to make solid progress in its lyophilized recombinant Protective Antigen (rPA) anthrax vaccine development program. The company has recently demonstrated that its lyophilized rPA vaccine candidate is structurally stable and potent at various temperatures up to and including 70 degrees centigrade. In addition, new non-clinical data, which will be presented next week at the upcoming 2010 International Conference on Emerging Infectious Diseases, July 11-14 in Atlanta, Georgia, demonstrate improved immunogenicity of the lyophilized vaccine formulation when compared to the liquid formulation.
Eric I. Richman, President and Interim Chief Executive Officer, commented, “PharmAthene is committed to working with and serving the needs of our customer, the United States government, through the innovation and development of next generation anthrax vaccines that offer important enhancements over first generation products. We have developed a portfolio of leading anthrax countermeasures encompassing second and third generation anthrax vaccine candidates based on rPA and a novel anti-toxin therapeutic, which meet these criteria. We continue to work closely with our partners at the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority to advance these important medical countermeasures to protect Americans at home and on the battlefield.” Various government agencies, as well as the Institute of Medicine, have acknowledged the urgent need to develop and stockpile next generation anthrax vaccines employing modern vaccine technology, which offer the potential for improved safety, convenience, cost-effectiveness, and more rapid immunity. PharmAthene’s second generation rPA anthrax vaccine candidate, SparVaxT, is being developed to fulfill these requirements.
Mr. Richman continued, “As we focus on meeting the needs of our customer today with the development of improved, second generation vaccines, we are also working concomitantly to innovate the next generation of anthrax vaccines that will deliver even greater benefit to our nation and its citizens. One of the goals of our rPA program is to develop a stable cold-chain-free vaccine, which could be stored and distributed at room temperature – an important advantage for deployment in the civilian Strategic National Stockpile. Although at an earlier stage of development, a lyophilized formulation of rPA could meet the requirements for a cold-chain-free vaccine and we are enthusiastic about the prospects for this program.” The Company has recently achieved an important milestone in its NIH sponsored lyophilized rPA program and completed the manufacture of approximately 14,000 doses of lyophilized rPA vaccine, produced under cGMP (current Good Manufacturing Practices) conditions, which is intended to be used in ongoing development work.
Funding for the lyophilized rPA vaccine program was provided under a Challenge grant (UC1 AI067223-01) from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.