Pfenex Inc, a clinical-stage biologics company engaged in the development of biosimilar therapeutics, announced 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," stated Bertrand C. Liang, CEO of Pfenex Inc. "The ability to meet articulated medical countermeasure needs, including fulfillment of the requirements of the Strategic National Stockpile, is a key goal in the programme."
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.