Pfenex enters anthrax vaccines realm with $143.5M BARDA contract

While San Diego-based Pfenex's ($PFNX) primary focus isn't on vaccines, the company gained a big backer in the space Monday with the announcement that the U.S. government has agreed to work with the biotech on its anthrax vaccine candidate for bioterror protection.

Pfenex's Patrick Lucy

In a deal potentially worth up to $143.5 million, the Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) said it would partner with Pfenex to develop Px563L, a mutant recombinant protective antigen anthrax vaccine.

The funding is "quite attractive," Chief Business Officer Patrick Lucy said in an interview, because it's a cost plus fixed fee contract and there's no equity required to fund the candidate's development. The initial portion of the government-funded work will focus on a Phase Ia trial, while later milestone-based periods could include further clinical studies and work on manufacturing processes. In the long term, Pfenex hopes to achieve a procurement contract and to help the government achieve the goal of stockpiling 75 million active doses.

The candidate's strengths, Lucy said, are that it can be quickly manufactured--Pfenex has demonstrated the ability to produce millions of doses in a "matter of weeks"--and its dosing schedule. It was developed on the biotech's expression technology platform, which to date has been utilized in a variety of applications, primarily biosimilars, Lucy said, though the company discovered its potential in vaccines a while back.

However, despite any advantages the company and its candidate may have, it'll be heading up against established anthrax vaccine provider Emergent BioSolutions ($EBS). The Maryland-based biotech--also partnered with BARDA--in March received a $31 million development agreement to fund a Phase III study of its NuThrax. That candidate has been funded through Phase I and II by the NIH and DOD and offers an improved dosing schedule over its own older, FDA-approved BioThrax while not requiring refrigeration. Initiated in 2011, Emergent has a 5-year contract worth up to $1.25 billion to supply its older vaccine to the national stockpile. Biotechs PharmAthene and Soligenix are working on candidates of their own.

HHS has been seeking improved anthrax remedies since anthrax-laced letters mailed to media outlets and government offices in 2001 killed 5 people and infected 17.

- here's Pfenex's release
- and the BARDA statement

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