OMP-54F28 (Fzd8-Fc) Program Reaches Dose Escalation Milestone in Phase 1a Clinical Trial; Triggers $15 Million Payment From Bayer Pharma AG

REDWOOD CITY, Calif., Nov. 5, 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, announced today that it has earned a $15 million milestone payment from Bayer Pharma AG related to achieving a dose escalation milestone in the Phase 1a clinical trial of OMP-54F28 (Fzd8-Fc). OMP-54F28 is an antagonist of the Wnt pathway, a key cancer stem cell pathway. 

The Phase 1a clinical trial of OMP-54F28 is an open-label dose escalation study in patients with advanced solid tumors. It is designed to assess OMP-54F28 for safety, immunogenicity, pharmacokinetics, biomarkers, and initial signals of efficacy. In the ongoing study, OMP-54F28 has been well tolerated at doses up to 15 mg/kg every three weeks, which is above the target efficacious dose based on OncoMed's preclinical studies in minimally passaged human tumor xenograft models. First-in-human data from the Phase 1a study detailing OMP-54F28 safety, pharmacokinetics, pharmacodynamics and early signs of efficacy were recently presented at the 2013 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston.

Jakob Dupont, M.D., OncoMed's Chief Medical Officer, commented, "OMP-54F28 demonstrates promising tolerability and early signs of potential anti-tumor activity, as well as Wnt pathway modulation in clinical samples. The early clinical data from the OMP-54F28 program indicate that this compound is a distinct and differentiated Wnt pathway antagonist that is ready for later-stage clinical development in combination with standard-of-care chemotherapy and targeted therapy."

"With the contribution of this $15 million milestone payment from Bayer, OncoMed has achieved a total of $33 million in milestone payments this year from our two corporate partners," said Paul J. Hastings, Chairman and Chief Executive Officer of OncoMed Pharmaceuticals. "We look forward to initiating multiple Phase 1b studies for OMP-54F28 in the coming months in parallel with the continued advancement of our four other ongoing anti-cancer stem cell clinical programs."

OMP-54F28 is one of five anti-CSC product candidates currently being advanced through clinical studies by OncoMed and the company's second distinct Wnt-pathway modulating therapeutic to enter the clinic as part of the collaboration between OncoMed and Bayer. OncoMed's first Wnt pathway anti-cancer stem cell compound, vantictumab (OMP-18R5, Anti-FZD7), is being advanced into three Phase 1b combination clinical studies. The first of these trials was recently initiated in patients with advanced breast cancer to evaluate the combination of vantictumab with paclitaxel. Bayer retains an option to exclusively license OMP-54F28 and/or vantictumab at any point through completion of certain Phase 1 trials.

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 OMP-54F28 (Fzd8-Fc)

OMP-54F28 is a first-in-class fusion protein that has shown broad anti-CSC and anti-tumor activity in patient-derived xenograft tumor models.  OMP-54F28 inhibits a key signaling pathway in cancer, the Wnt pathway. Specifically, OMP-54F28 consists of the extracellular ligand-binding domain of the Frizzled 8 receptor and the Fc domain of a human IgG1 antibody. OMP-54F28 selectively binds Wnt ligands, which are activators of Wnt signaling. OMP-54F28 is currently in Phase 1a in patients with refractory solid tumors. Data from the OMP-54F28 solid tumor trial were presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston, MA, in October 2013.  OMP-54F28 is part of OncoMed's collaboration with Bayer Pharma AG.

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:

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 trials for OMP-54F28 and vantictumab; the tolerability of OMP-54F28 and vantictumab at efficacious doses in humans; the potential of OMP-54F28 and vantictumab to improve patient outcomes; the differentiation of OMP-54F28 from vantictumab; 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, including the timing of Phase 1b trials for OMP-54F28 and vantictumab. 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.

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