Biolex Inc. registered to raise up to $70 million in an initial public offering, funds that would be used to advance its lead product for hepatitis C and other programs.
The Research Triangle Park, N.C., company uses its LEX System to develop hard-to-make therapeutic proteins and optimized monoclonal antibodies. The system is based on technology that genetically transforms the aquatic plant Lemna to enable the production of biologic product candidates.
The company expects the technology to address drawbacks in traditional production systems, and result in product candidates with improved efficacy and tolerability profiles.
Its lead product candidate, Locteron, is a controlled-release interferon alfa agent being tested in Phase II trials. Biolex in the first half of 2008 plans to initiate a 72-week, 100-patient Phase IIb trial (SELECT-2) in Europe comparing three doses of Locteron in combination with ribavirin against a control arm of pegylated interferon alfa and ribavirin. If early data are promising, the company expects to begin Phase III trials in 2009.
Locteron is being developed in collaboration with OctoPlus NV, of Leiden, the Netherlands, the developer of the PolyActive controlled-release technology used in the product. It allows for delivery every two weeks, compared to weekly dosing used in the pegylated product.
Biolex and OctoPlus last month reported positive initial results from their ongoing SELECT-1 (Safety and Efficacy of Locteron: European Clinical Trial) Phase IIa study, as treatment in combination with ribavirin showed an early virologic response in 100 percent of patients treated. A dose response also was observed. Final results from the study are expected to be reported in the fourth quarter.
Biolex preclinical products based on the LEX System include BLX-155, a direct-acting thrombolytic designed to dissolve blood clots in patients, and BLX-301, an anti-CD20 antibody for treating non-Hodgkin's B-cell lymphoma and other diseases. The company also is using its LEX System in partnerships with at least four other companies.
The company in its registration statement did not estimate the number of shares to be offered or the expected price range. Lehman Brothers Inc. and Deutsche Bank Securities Inc. are joint book-running managers for the offering, and Leerink Swann & Co. Inc. is co-manager.
Biolex in May completed a $30 million Series C financing round, giving it $32.5 in cash as of March 31 on a pro forma basis. It raised $36 million in a Series B round in 2005. (See BioWorld Today, Sept. 1, 2005, and May 25, 2007.)
Among the company's largest shareholders are Intersouth Partners, Johnson & Johnson Development Corp., Quaker BioVentures LP, Polaris Venture Partners, Investor Growth Capital Ltd. and Mitsui & Co. Venture Partners.
Biolex reported a net loss of $17.5 million in 2006. In the prospectus, it said funds from the IPO would be expected to support operations into 2009. Its proposed Nasdaq ticker symbol is "BLEX."