PharmAthene announced today that the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has awarded the Company a contract, valued at up to $28.1 million if all contract options are exercised, for the development of a next generation anthrax vaccine based on the company’s proprietary rPA anthrax vaccine technology platform.
Various government agencies, including the Institute of Medicine, have acknowledged the 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 anthrax vaccine will be lyophilized for optimal ease of storage and administration. Based on preliminary in vitro and in vivo animal data, the Company believes that the new lyophilized formulation should result in a vaccine which is thermostable and shows improved long-term stability, cold-chain-free storage stability, and enhanced immunopotency compared to existing liquid anthrax vaccines.
Eric I. Richman, President and Chief Executive Officer, commented, “A lyophilized, next generation anthrax vaccine could be effective in fewer doses and be stored and distributed at room temperature – an important advantage for deployment in the government’s civilian Strategic National Stockpile. We look forward to working collaboratively with NIAID/NIH on the development of this advanced vaccine.” The Company has previously demonstrated that a lyophilized rPA vaccine candidate is structurally stable and protected mice from a lethal dose of anthrax spores in a challenge assay after storage at various temperatures up to 70 degrees Centigrade, or 158 degrees Fahrenheit.
In addition, previous non-clinical studies have demonstrated that a lyophilized rPA vaccine candidate, reconstituted at less than two hours prior to use, was more immunogenic in rabbits than the liquid rPA vaccine formulation, when measured by both toxin neutralization assay (TNA) NF50 (p=0.007) and enzyme linked immunosorbent assay (ELISA) (p=0.023).
Funding for the lyophilized rPA vaccine program will be provided under BAA-NIAID-DMID-NIHA12013174 under the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.