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