US-based Pfenex has received a $143.5m five-year contract from the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (HHS) to advance development of Px563L, a mutant recombinant protective antigen anthrax vaccine.
As part of the deal, the fund will be used for activities relating to current good manufacturing practice (cGMP) of drug product and a Phase Ia clinical study.
The contract’s milestone-based option periods comprise completion of a Phase Ib clinical study, a Phase II clinical study and non-clinical efficacy studies.
It will also include the manufacturing technology transfer and optimisation, process and analytical method validation and consistency lot manufacture.
Pfenex CEO Bertrand Liang said: “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 US Government.
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“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.”
Successful completion of the activities will help Pfenex secure a contract to supply Px563L to the strategic national stockpile.
Pfenex is involved in the development of biosimilar therapeutics and high-value and difficult to manufacture proteins
Its lead product candidate is PF582, a biosimilar candidate to Lucentis (ranibizumab), for treatment of patients with retinal diseases.
Image: Photomicrograph of a Gram stain of the bacterium Bacillus anthracis, the cause of the anthrax disease. Photo: courtesy of CDC.