Pfenex is a leading-edge biologics company. Courtesy/pfenex.com
San Diego, California-based Pfenex Inc. has announced that it has signed a five year, cost plus fixed fee 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,” Pfenex CEO Bertrand C. Liang 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.”
Under the contract, the 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, BARDA Director Robin Robinson 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.”
The Center for Disease Control and Prevention (CDC) says that the anthrax bacterium, Bacillus anthracis, causes different symptoms related to how it enters the body:
- Inhalation anthrax causes fevers and chills; shortness of breath and discomfort in the chest; coughing, extreme fatigue; and other symptoms. It is the most deadly form of anthrax.
- Cutaneous anthrax can produce itchy blisters or bumps; a painless ulcer with a black center, appearing after the blisters or bumps; and swelling around the sores.
- Injection anthrax causes much the same symptoms as cutaneous anthrax.
- Gastrointestinal anthrax can cause fevers and chills; neck swelling; hoarseness; nausea; stomach pain; bloody diarrhea, and other symptoms.
Symptoms can develop from one day to two months after exposure.
Paul Wagner, chief financial officer of Pfenex told the Union Tribune that “The government has indicated that they’re looking to have a stockpile of 75 million doses.”
Source: Homeland Security News Wire