Morphotek Announces An Agreement With Fujirebio Diagnostics, Inc. To Commercialize The CA125 II Assay As A Companion Diagnostic For Farletuzumab

EXTON, Pa., Sept. 5, 2017 /PRNewswire/ -- Morphotek^®, Inc., a subsidiary of Eisai Inc., announced today 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.

About Morphotek

Morphotek^®, Inc., a subsidiary of Eisai Inc., is a clinical-stage biotechnology company focused on developing novel classes of biological-based products to treat cancer, inflammatory and infectious diseases. Our mission is to develop novel targeted therapies that attack underlying disease pathways, and in oncology indications can overcome the immunosuppressive effects by tumors on immune-mediated experimental therapies. Our diverse pipeline includes clinical-stage monoclonal antibodies to lead targets folate receptor alpha, mesothelin and endosialin, as well as antibody-drug conjugates and bispecific antibodies to undisclosed targets in preclinical development. Our mission is supported by proprietary cutting-edge technologies in antibody engineering, manufacturing and screening optimization platforms, along with our expertise in developing diagnostics to support patient selection and therapeutic strategy. For more information, please visit www.morphotek.com.

About Eisai Inc.

At Eisai Inc., human health care (hhc) is our goal. We give our first thought to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to discover and develop innovative therapies to help address unmet medical needs.

Eisai is a fully integrated pharmaceutical business that operates in two global business groups: oncology and neurology (dementia-related diseases and neurodegenerative diseases). Each group functions as an end-to-end global business with discovery, development, and marketing capabilities. Our U.S. headquarters, commercial and clinical development organizations are located in New Jersey; our discovery labs are in Massachusetts and Pennsylvania; and our global demand chain organization resides in Maryland and North Carolina. To learn more about Eisai Inc., please visit us at www.eisai.com/US and follow us on Twitter and LinkedIn.

About Fujirebio Diagnostics, Inc.

Fujirebio Diagnostics Inc., a subsidiary of Fujirebio Holdings, Inc., is the premier cancer diagnostics company and the industry leader in cancer biomarker assays. The company pioneered and introduced the CA125 test, the first FDA-approved ovarian cancer biomarker over 25 years ago. Fujirebio Diagnostics specializes in the clinical development, manufacturing and commercialization of in vitro diagnostic products for the management of human disease states, with an emphasis in oncology. For more information about Fujirebio Diagnostics, please call +1 610-240-3800 or visit us at www.fujirebio-us.com.

About Fujirebio

Fujirebio is a global leader in the field of high quality in vitro diagnostics (IVD) testing. It has more than 50 years’ accumulated experience in the conception, development, production and worldwide commercialization of robust IVD products. Fujirebio has a strong and long-lasting tradition of collaborating with experts in the worldwide clinical community in the development of high-quality routine and truly novel biomarkers that cover a variety of disease states. Its IVD product lines span the range from specialized manual and automated testing to fully automated routine clinical laboratory testing solutions.

Fujirebio is today a member of Miraca Group (Miraca Holdings Inc. listed on the Tokyo Stock Exchange TYO: 4544) and employs more than 1,200 people in Asia, Europe and America.

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SOURCE Morphotek, Inc.