Pfenex’s technology platform is based on the automated high-throughput screening of large libraries of novel, genetically engineered Pseudomonas fluorescens bacterial expression strains, and the firm are currently contracted by the Biomedical Advanced Research and Development Authority (BARDA) to use it in developing anthrax vaccines.
However, in a form S-1 filed with the SEC in which the San Diego, California-based firm is looking to raise $74.8m in an IPO, Pfenex laid out plans to develop biosimilars, beginning with PF582 which is a version of Genentech’s monoclonal antibody drug Lucentis (Ranibizumab).
“We believe [our platform] confers several important competitive advantages compared to traditional techniques for protein production including the ability to produce complex proteins with higher accuracy and greater degree of protein purity, as well as significant speed and cost advantages,” the firm said in its prospectus.
The Expression Technology was first developed at Mycogen Corporation and further developed at Dow, before being assigned to Pfenex in 2009 when the company span-out from the latter.
The platform does not rely on trial and error in the protein production process but rather performs thousands of parallel experiments which can produce a strain that generates high quality, high titre proteins in less than nine weeks, compared to what the firm says is on average a one year process.
“The power of our platform has been demonstrated by our ability to move PF582 from concept to the clinic in just 24 months.”
Lucentis – which had worldwide sales of approximately $4.3bn in 2013 – is used to treat wet age-related macular degeneration (AMD), and Pfenex’s biosimilar version is currently in Phase 1b clinical trials.
The firm is also developing six other biosimilars in a joint venture with Agila Biotech, a subsidiary of Strides Arcolab. These include an equivalent to Bayer’s interferon beta-1b drug Betaseron, Amgen’s Neulasta (Pegfilgrastim), and Pfizer’s human growth hormone Genotropin.
“We believe the emerging biosimilar market will be significant due to the large number of blockbuster products losing patent protection in the next several years, abbreviated regulatory pathways for the approval of biosimilars and a mandate for lower drug costs by governments and private payors.”