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 19th 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.
"Clinical biomarkers are a key component of all of OncoMed's clinical development programs to improve the selection of patients most likely to benefit from certain treatments and as a measure of on-target activity," Paul J. Hastings, OncoMed's Chairman and Chief Executive Officer. "We are pleased to report progress on the development and validation of a novel companion diagnostic to complement our anti-Notch1 therapeutic development program in hematologic cancers. Later this year, we expect to roll out a similar assay for our anti-Notch1 solid tumor program."
Data for the Notch1 companion diagnostic assay will be presented this afternoon at the EHA Congress during the Chronic lymphocytic leukemia and related disorders - Clinical 2 session in a poster titled, "Development and validation of a Notch1 custom NGS assay for identifying Notch1 mutations in chronic lymphocytic leukemia and other lymphoid malignancies (Abstract #P861)".
About Anti-Notch1 (OMP-52M51)
Anti-Notch1 is a first-in-class antibody that selectively targets the Notch1 receptor and prevents signaling through a key signaling pathway in cancer, the Notch pathway. In preclinical models, anti-Notch1 has been shown to have broad-spectrum anti-tumor activity via inhibition of cancer stem cell growth, and promoting cell differentiation, as well as disrupting tumor angiogenesis. Certain lymphoid malignancies and solid tumors have abnormal activation of the Notch1 receptor that can be a key driver of these tumors. Anti-Notch1 is being developed with potential predictive biomarker companion diagnostics.
Anti-Notch1 is currently in Phase 1 in two first-in-human trials, one in lymphoid malignancies and one in certain solid tumors. First-in-human data from the anti-Notch1 refractory solid tumor trial were presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston, MA, in October 2013. Interim results form the Phase 1 study demonstrated good tolerability thus far with the main target-mediated toxicity of diarrhea. Anti-Notch1 is part of OncoMed's collaboration with GlaxoSmithKline.
About OncoMed Pharmaceuticals
OncoMed Pharmaceuticals is a clinical-stage company focused on discovering and developing novel therapeutics targeting cancer stem cells (CSCs). OncoMed has five anti-cancer product candidates in clinical development, including demcizumab (anti-DLL4, OMP-21M18), tarextumab (anti-Notch2/3, OMP-59R5), anti-Notch1 (OMP-52M51), vantictumab (anti-Fzd7, OMP-18R5), and Fzd8-Fc (OMP-54F28), which target key cancer stem cell signaling pathways including Notch and Wnt. OncoMed has two other antibodies in preclinical development, anti-DLL4/anti-VEGF bispecific (OMP-305B83) and anti-RSPO3 (OMP-131R10), with Investigational New Drug filings planned for late 2014 or early 2015. OncoMed is also pursuing discovery of additional novel anti-CSC product candidates. OncoMed has formed strategic alliances with Celgene Corporation, Bayer Pharma AG and GlaxoSmithKline (GSK). Additional information can be
found at the company's website:
To the extent that statements contained in this press release are not descriptions of historical facts regarding OncoMed Pharmaceuticals, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including OncoMed's expectations regarding the success of Phase 1 clinical trials for anti-Notch1 (OMP-52M51); the successful development of predictive biomarkers and companion diagnostics for anti-Notch1; the performance of the Notch1 mutation biomarker assay; the timing of implementation of a companion diagnostic in the anti-Notch1 solid tumor program; and the timing of Investigational New Drug filings for OncoMed's anti-DLL4/anti-VEGF bispecific and anti-RSPO3 antibodies. Such forward-looking statements involve substantial risks and uncertainties that could cause OncoMed's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the preclinical and clinical development process; the risks and uncertainties of the regulatory approval process; OncoMed's dependence on its collaboration partners, including Celgene, GSK and Bayer, for the funding of its partnered programs; OncoMed's ability to raise additional capital to support the development of its unpartnered programs; OncoMed's dependence on the development and marketing efforts of its partners for the commercial success of its partnered product candidates; OncoMed's reliance on third parties to conduct certain preclinical studies and all of its clinical trials; OncoMed's reliance on single source third-party contract manufacturing organizations to manufacture and supply its product candidates; OncoMed's ability to validate, develop and obtain regulatory approval for companion diagnostics; OncoMed's ability to achieve market acceptance and commercial success of its product candidates once regulatory approval is achieved; OncoMed's ability to discover, develop and commercialize additional product candidates; the ability of competitors to discover, develop or commercialize competing products more quickly or more successfully; OncoMed's dependence on its Chairman and Chief Executive Officer, its Chief Scientific Officer, its Chief Medical Officer and other key executives; risk of third party claims alleging infringement of patents and proprietary rights or seeking to invalidate OncoMed's patents or proprietary rights; and the ability of OncoMed's proprietary rights to protect its technologies and product candidates. OncoMed undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to OncoMed's business in general, see OncoMed's Annual Report on Form 10-K for the fiscal year ended December 31, 2013, filed with the Securities and Exchange Commission (SEC) on March 18, 2014, and OncoMed's Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2014, filed with the SEC on May 8, 2014.
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