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Pfenex wins $143.5m BARDA contract to develop new anthrax vaccine

US-based biotechnology firm Pfenex has secured a five-year $143.5m contract from the biomedical research arm of the US Department of Health and Human Services (HHS) to develop Px563L, a mutant recombinant protective antigen (rPA) anthrax vaccine.

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The contract with the Biomedical Advanced Research and Development Authority (BARDA) will fund activities related to current Good Manufacturing Practice (cGMP) manufacturing of a drug product and a Phase Ia clinical trial.

Under the deal, milestone-based option periods include completion of a Phase Ib trial, a Phase II study and non-clinical efficacy studies as well as manufacturing technology transfer and optimization, process and analytical method validation and consistency lot manufacture.

Pfenex chief executive officer 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.

"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 development has been funded in whole or in part with federal funds from HHS; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority.

PF582 or Lucentis is the company’s lead product candidate for the potential treatment of patients with retinal diseases.

The company has leveraged its expression technology platform to build a pipeline of product candidates including biosimilars, vaccines, generics and next generation biologics.


Image: Pfenex gets $143.5m to develop next generation anthrax vaccine. Photo: courtesy of Baitong333 / freedigitalphotos.net.