REDWOOD CITY, Calif., June 14, 2014 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals Inc. (Nasdaq:OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, will present data for a novel assay developed with researchers at MolecularMD, Inc. to identify Notch1 mutation status in patients with certain hematologic malignancies. These data are being presented at the 19 th European Hematology Association (EHA) Congress. OncoMed's Notch1 mutation biomarker assay is being developed as a companion diagnostic to identify patients whose cancer may be more likely to benefit from treatment with the company's anti-Notch1 antibody, OMP-52M51.
In a series of comparative experiments detailed in the EHA presentation, this CLIA-validated assay demonstrated a high degree of accuracy, precision, sensitivity and specificity in detecting Notch1 activating mutations in FFPE tumor tissues and blood clinical samples. Notch1 mutations have been linked to more refractory lymphoid malignancies, such as chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), and others, putting patients at greater risk for poor outcomes and reduced overall survival. While Notch1 may be a valuable biomarker of therapeutic efficacy, the Notch1 gene presents specific challenges due to gene size and sequence to assay. The diagnostic assay was developed and validated using the Ion Torrent Next Generation DNA Sequencing (NGS) platform.
"There is an abundance of published evidence linking Notch1 mutation status to certain cancer types and to disease outcomes," said John Lewicki, Ph.D., Executive Vice President and Chief Scientific Officer of OncoMed Pharmaceuticals. "The performance demonstrated by our proprietary assay represents an important achievement due to the complexity and large size of the coverage required for the NOTCH1 gene. We are pleased to be implementing this assay as a companion diagnostic in our ongoing Phase 1 study of anti-Notch1 in hematologic malignancies."OncoMed is currently conducting two separate Phase 1a single-agent clinical studies of its Notch1 targeting antibody in patients with certain advanced solid and hematologic tumors, respectively. Based on data validating the accuracy and utility of the assay, the companion diagnostic is now being used in OncoMed's ongoing Phase 1a clinical study of anti-Notch1 in patients with hematologic malignancies. A second companion diagnostic directed at Notch1 mutations in solid tumors is currently in development.