Pfenex, a San Diego-based clinical-stage biologics company, 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,” said Bertrand C. Liang, chief executive officer of Pfenex. “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.”
The base period will fund activities related to current Good Manufacturing Practice (cGMP) manufacturing of drug product and a phase Ia clinical study. Milestone-based option periods include completion of a phase Ib clinical study, a phase II clinical study and nonclinical 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.