Pfenex Inc., a clinical-stage biotechnology company developing and commercializing difficult-to-manufacture proteins, filed a registration statement with the US Securities and Exchange Commission on June 6, 2014 for a proposed initial public offering of its common stock.

The company’s lead product candidate is PF582, a biosimilar candidate to Lucentis (ranibizumab). Lucentis, marketed by Roche and Novartis for the treatment of patients with retinal diseases. Pfenex is currently conducting a Phase Ib/IIa trial in patients with wet age-related macular degeneration with results expected in the fourth quarter of 2014. The company expects to begin a Phase III trial in mid-2015, with results expected in 2017. If approved, it plans to commercialize PF582 with its own internal sales and marketing capabilities in North America and Europe.

The company’s next most advanced product candidate is PF530, a biosimilar candidate to Betaseron (interferon beta-1b), which is marketed by Bayer AG for treating multiple sclerosis. Pfenex plans to initiate a Phase I trial in the second half of 2014. Pfenex’s pipeline also includes five other biosimilar candidates, as well as vaccine, generic, and next-generation biologic candidates.

The company’s production technology uses its proprietary PfÄ“nex Expression Technology, which is based on automated high-throughput screening of large libraries of novel, genetically engineered Pseudomonas fluorescens bacterial expression strains, to enable the selection of strains that express the protein of interest and which is then optimized to produce a given therapeutic protein. The technology was originated at Mycogen Corporation and further developed at The Dow Chemical Company, collectively over a period of 20 years, and was assigned to Pfenex Inc. as part of its 2009 spinout from Dow to form the basis of the company.

Source: Pfenex Inc.