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OncoMed Pharmaceuticals Initiates Second Phase 1b Clinical Trial of First-in-Class WNT-Pathway-Targeting Antibody Vantictumab (OMP-18R5) With Docetaxel in Non-Small Cell Lung Cancer (NSCLC)

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REDWOOD CITY, Calif., Nov. 15, 2013 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today announced that it has started a multi-center Phase 1b clinical trial of its first-in-class Wnt-pathway-targeting antibody vantictumab (OMP-18R5) with docetaxel in non-small cell lung cancer (NSCLC). This trial is the second of three Phase 1b trials for vantictumab that OncoMed expects to initiate this year as part of OncoMed's collaboration with Bayer Pharma AG.

The Phase 1b clinical trial is a dose escalation study of the anti-CSC antibody vantictumab in combination with docetaxel in patients with second- and third-line advanced NSCLC. Primary objectives of the trial are to evaluate safety of this combination regimen and determine a recommended Phase 2 dose for vantictumab in combination with docetaxel. Key secondary and exploratory objectives include evaluation of the pharmacokinetics (PK) and pharmacodynamics (PD) of vantictumab and the efficacy of this combination. Tumor tissue from patients will be used to explore predictive biomarker hypotheses related to the efficacy of vantictumab.

Grace Dy, M.D., Associate Professor at the Roswell Park Cancer Institute in Buffalo, New York, is the Principal Investigator who treated the first patient enrolled in this study. Dr. Dy commented, "The investigational agent vantictumab may offer a novel therapeutic approach to lung cancer by targeting the Wnt pathway which may play a significant role both in squamous and non-squamous cell lung cancers. Patients with lung cancer continue to be in need of better therapies, and we are excited about testing the combination of vantictumab with docetaxel in this clinical study based on preclinical data and the strong emphasis on tumor tissue analysis in the study."

The two other investigators and clinical sites to participate in the trial are Afshin Dowlati, M.D., of the Case Comprehensive Cancer Center at Case Western Reserve University, Cleveland, Ohio, and Ross Camidge, M.D. at the University of Colorado Cancer Center in Aurora, CO.

"Advanced recurrent non-small cell lung cancer remains an area of medical need. We are pleased to initiate this trial combining vantictumab, with its novel anti-cancer stem cell mechanism of action, with standard docetaxel chemotherapy and our preclinical studies have generated robust anti-tumor activity data for this combination," said Jakob Dupont, M.D., Chief Medical Officer of OncoMed. "From this trial we will learn more about the safety, biomarker effects, and potential efficacy of this novel Wnt pathway-targeting drug candidate in combination with chemotherapy in advanced NSCLC."

OncoMed recently initiated a Phase 1b study of vantictumab and paclitaxel in HER2 negative breast cancer. Interim results for the single-agent, first-in-human Phase 1a trial for vantictumab in solid tumor patients were reported at the European Cancer Congress (ECC) 2013 in Amsterdam, Netherlands in September 2013. Results from the Phase 1a study showed that vantictumab is well tolerated with early evidence of single agent activity. Additionally, clinical biomarker data from the Phase 1a trial indicating PD modulation of the Wnt pathway by vantictumab were presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston, MA in October 2013.

"OncoMed continues to execute on its clinical trial plans, initiating studies on a timely basis, partnering with top-tier oncology centers and generating encouraging new data," said Paul J. Hastings, OncoMed's Chairman and Chief Executive Officer. "With the commencement of this trial of vantictumab in NSCLC, we have eleven trials actively enrolling patients across five distinctive therapeutic programs."

About Vantictumab (OMP-18R5)

Vantictumab is a first-in-class antibody that has shown broad anti-CSC and anti-tumor activity in patient-derived xenograft tumor models. Vantictumab inhibits a key signaling pathway in cancer, the Wnt pathway. Specifically, vantictumab selectively targets Frizzled receptors, which are activators of Wnt signaling. Although vantictumab was originally identified by binding to Frizzled7, the antibody selectively targets five different Frizzled receptors. A Phase 1a trial for vantictumab is currently ongoing. Data from this clinical trial were presented at the European Cancer Conference (ECC 2013) in September 2013 in Amsterdam, NL. Biomarker data for this Phase 1a trial was presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston, MA, in October 2013. Vantictumab is also being tested in combination with standard-of-care chemotherapy in a Phase 1b clinical trial in advanced NSCLC (vantictumab + docetaxel) and in a Phase 1b clinical trial in HER2 negative breast cancer (vantictumab + paclitaxel). An additional Phase1b trial is planned to start in 2013 with vantictumab in combination with standard-of-care chemotherapy in another distinct solid tumor indication. Vantictumab is part of OncoMed's collaboration with Bayer Pharma AG.

About 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. CSCs, also known as tumor-initiating cells, exhibit certain properties which include the capacity to divide and give rise to new CSCs via a process called self-renewal and the capacity 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, Inc., 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 (OMP-21M18, Anti-DLL4), OMP-59R5 (Anti-Notch2/3), OMP-52M51 (Anti-Notch1), vantictumab (OMP-18R5, Anti-Fzd7), and OMP-54F28 (Fzd8-Fc), which target key CSC signaling pathways including Notch and Wnt. OncoMed has two other antibodies in preclinical development with Investigational New Drug filings planned as early as 2014. OncoMed is also pursuing discovery of additional novel anti-CSC product candidates. OncoMed has formed strategic alliances with 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 1b trials for vantictumab in NSCLC and breast cancer; the potential of vantictumab to improve patient outcomes, particularly in NSCLC patients; the potential for development of predictive biomarkers for vantictumab, especially in NSCLC and breast cancer; the tolerability of vantictumab at efficacious doses; the potential of OncoMed's product candidates to significantly impact cancer treatment and the clinical outcome of patients with cancer; and the timing of Investigational New Drug filings and clinical trials. 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 GSK and Bayer, for the funding of its partnered programs; OncoMed's ability to raise 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 Prospectus filed with the Securities and Exchange Commission on July 18, 2013 and OncoMed's Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2013, filed with the Securities and Exchange Commission on September 3, 2013.

CONTACT: Investor Contact: OncoMed Pharmaceuticals Shari Annes Investor Relations (650) 888-0902 shari.annes@oncomed.com Media Inquiries: BCC Partners Karen L. Bergman or Michelle Corral (650) 575-1509 or (415) 794-8662 kbergman@bccpartners.com or mcorral@bccpartners.com

Source:OncoMed Pharmaceuticals, Inc.