REDWOOD CITY, Calif., June 4, 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 new data at the upcoming 19th European Hematology Association (EHA) Congress related to the company's anti-Notch1 (OMP-52M51) clinical-stage program.
At the EHA Congress, OncoMed will present the first data for its proprietary Next Generation DNA Sequencing (NGS) assay developed with MolecularMD (Portland, OR) to identify Notch1 mutation status in patients with certain hematologic malignancies. Notch1 mutations have been linked to more refractory lymphoid malignancies, such as chronic lymphocytic leukemia (CLL), mantle cell lymphoma, and others, putting patients at greater risk for poor outcomes and reduced overall survival. 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. OncoMed is currently conducting two separate Phase 1 clinical studies of its Notch1 targeting antibody in patients with certain advanced solid and hematologic tumors, respectively.
The following abstract is available at the EHA website and has been selected for presentation during the Congress:
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Abstract #P861: Development and validation of a Notch1 custom NGS assay for identifying Notch1 mutations in chronic lymphocytic leukemia and other lymphoid malignancies
Date and time: Saturday, June 14, 2014 at 5:45 PM – 7:00 PM
Session: Chronic lymphocytic leukemia and related disorders - Clinical 2
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 from 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.
Cancer Stem Cells
Cancer stem cells, or CSCs, are the subpopulation of cells in a tumor responsible for driving growth and metastasis of the tumor. Also known as tumor-initiating cells, CSCs have the capacity to divide and give rise to new cancer stem cells via a process called self-renewal and to differentiate or change into the other cells that form the bulk of the tumor. Common cancer drugs target bulk tumor cells but have limited impact on CSCs, thereby providing a path for recurrence of the tumor. OncoMed's product candidates target CSCs by blocking self-renewal and driving differentiation of CSCs toward a non-tumorigenic state, and also impact bulk tumor cells. OncoMed believes its product candidates are distinct from the current generations of chemotherapies and targeted therapies, and have the potential to significantly impact cancer treatment and the clinical outcome of patients with cancer.
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: www.oncomed.com.
Forward-Looking Statements
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 tolerability of anti-Notch1 at efficacious doses; the successful development of predictive biomarkers and companion diagnostics for anti-Notch1; the potential of OncoMed's product candidates such as anti-Notch1 to significantly impact cancer treatment and the clinical outcome of patients with cancer; the scope, validity, and enforceability of the protection for the Notch1 NGS assay afforded by OncoMed's intellectual property; and the timing of clinical trials and Investigational New Drug filings for OncoMed's product candidates. 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.