Status: U.S. biodefense stockpiling contract

Organizations involved:

Pfenex Inc. – Manuf.; R&D; Tech.

Glide Pharmaceutical Technologies Ltd. – R&D; Tech.

Centers for Disease Control and Prevention (CDC) – USA mark. [stockpiling]

Cross ref.: See the entries regarding other recombinant anthrax vaccine, and the generic Anthrax Vaccines entry (#404).

Description: Pfenex is developing a recombinant Bacillus anthracis (anthrax) protective antigen for addition to the U.S. biodefense stockpile (and that of other countries). The rPA is expressed in Pseudomonas fluorescens bacteria and and otherwise is the same or very similar to rPA 102 previously manufactured (or attempted) by VaxGen (see related above) and, presumably, other rPA vaccines in develoment.

Nomenclature: Anthrax Vaccine, rDNA/Emergent [BIO]; rPA vaccine [SY]; rPA102 [SY]; Bacillus anthracis protective antigen vaccine, recombinant [SY].

Companies.: In July 2010, Pfenex Inc. was granted a contract through the Biomedical Advanced Research and Development Authority (BARDA) providing for up to a total of $18.8 million in funding for development of a robust Pfenex Expression Technology (a Pseudomonas-based expression system) based production strain and process for the production of bulk recombinant protective antigen (rPA). In May 2012, BARDA extended this contact, with funding for scale-up and manufacture of vaccine for clinical trials.

In April 2013, Glide Pharma was awarded a sub-contract from Pfenex Inc. to develop a solid formulation containing the recombinant Protective Antigen (rPA) from Bacillus anthracis expressed in Pfēnex Expression Technology suitable for delivery with the Glide SDI (solid dose injector). This approach will address two important logistical constraints of the currently available vaccine, namely, long term stability during storage and ease of administration.

FDA class: Biologic BLA

Status: As of April 2013, "Pfenex has successfully developed a novel rPA that is highly immunogenic and protective in animal studies, with a scalable production process and robust yields."