Anthrax

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.

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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.

“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.”

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.