Morphotek, Inc., a subsidiary of Eisai Inc., announced that it entered into a collaboration and license agreement with Fujirebio Diagnostics, Inc. (Fujirebio Diagnostics) to validate and commercialize the CA125 II assay for use on the Lumipulse Instrument System as a companion diagnostic to aid in the selection of ovarian cancer patients who may best respond to Morphotek's investigational antibody, farletuzumab.  

Farletuzumab is an investigational, humanized, monoclonal antibody that binds to folate receptor alpha, which is highly expressed in ovarian cancer and some other epithelial tumors, but generally absent from normal tissue.  The agreement provides Fujirebio Diagnostics with a worldwide license to develop, manufacture and commercialize the CA125 II assay as a companion diagnostic.  

"We are excited to partner with Fujirebio Diagnostics and further develop their CA125 II assay as a companion diagnostic to select ovarian cancer patients with threshold levels of CA125 that may best respond to our investigational agent, farletuzumab," stated Nicholas Nicolaides, President and CEO, Morphotek, Inc.

Farletuzumab (MORAb-003) has been evaluated in a randomized, placebo-controlled Phase 3 trial in combination with carboplatin plus taxane in patients with relapsed platinum-sensitive ovarian cancer. Pre-specified subset analyses demonstrated that farletuzumab-treated subjects with low CA125 levels (less than three times the upper limit of normal) correlated with longer PFS and OS than those treated with placebo.  CA125 is a tumor-shed protein that is elevated in the blood of most ovarian cancer patients and is used clinically as a standard to monitor an ovarian cancer patient's response to therapy.  CA125 has been reported to suppress farletuzumab-mediated natural killer (NK) cell function, suggesting that higher CA125 levels may suppress the immune-effector response mechanism of farletuzumab's anti-tumor activity.

"The use of CA125 in patient selection for farletuzumab is further validation of the clinical value of CA125 in the management of patients with ovarian cancer.  The opportunity to use a traditional oncology biomarker as a companion diagnostic in ovarian cancer therapy gives physicians a new utilization for CA125," stated Monte Wiltse, President and CEO, Fujirebio Diagnostics, Inc.