PharmAthene, Inc. this week announced 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 for the development of a next-generation anthrax vaccine.
PharmAthene’s SparVax recombinant protective antigen (rPA) 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.
“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,” stated Eric I. Richman, President and Chief Executive Officer. “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.
Additionally, 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.
PharmAthene’s current biodefense portfolio also includes: rBChE bioscavenger – a medical countermeasure for nerve agent poisoning by organophosphorous compounds; Valortim – a fully human monoclonal antibody for the prevention and treatment of anthrax infection; a plague vaccine; and proprietary antimicrobials directed towards MRSA.
Source: PharmAthene press release, adapted.
