Anthrax Vaccine To Be Developed In The U.S.

Anthrax Vaccine To Be Developed In The U.S.

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San Diego, California-based Pfenex Inc. announced it has signed a five year contract valued at up to $143.5 million with the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (HHS), for the advanced development of Px563L, a mutant recombinant protective antigen anthrax vaccine.

“This contract for the development of Px563L offers the potential for a dramatic improvement in the rapid production of large amounts of a high value stable recombinant anthrax vaccine for the U.S. government,” Bertrand C. Liang, CEO of Pfenex, said. “The ability to meet articulated medical countermeasure needs, including fulfillment of the requirements of the Strategic National Stockpile, is a key goal in the program.”

According to HomeLand Security News wire the contract’s base period will fund activities related to current Good Manufacturing Practice (cGMP) manufacturing of drug product and a Phase 1a clinical study. Milestone-based option periods include completion of a Phase 1b clinical study, a Phase 2 clinical study and non-clinical efficacy studies as well as manufacturing technology transfer and optimization, process and analytical method validation and consistency lot manufacture. Pfenex believes the successful completion of the activities under this contract could lead to a procurement contract for supply of Px563L to the Strategic National Stockpile.

Anthrax no longer makes the headlines, but the danger of anthrax use in bioterrorism remains, Robin Robinson, director of BARDA, told the San Diego Union-Tribune.

“The Department of Homeland Security has determined that anthrax remains a threat to national security,” Robinson said. “There have been no successful anthrax attacks since 2001, but the threat still persists. The Pfenex vaccine represents a next-generation anthrax vaccine candidate that may be more stable and easier to mass produce and to administer at less cost than the currently licensed anthrax vaccine.”

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