9-29-13 3:31 AM EDT | Email Article

Vantictumab is well tolerated and has surpassed the target efficacious dose from preclinical models

Vantictumab has pharmacodynamic effect on the WNT-pathway and evidence of single-agent activity

Vantictumab is advancing to combination Phase 1b studies in selected tumor types

REDWOOD CITY, Calif., Sept. 29, 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 reported new data for vantictumab, a monoclonal antibody targeting the WNT pathway, at a poster session at the Joint ECCO 17, 38th ESMO and 32nd ESTRO European Cancer Congress 2013 (ECC 2013) in Amsterdam, The Netherlands.

In the ongoing Phase 1a clinical trial, 29 patients with advanced and refractory solid tumors were treated with single-agent vantictumab. To date the drug candidate has been well tolerated up to the current dose of 15 mg/kg every three weeks. This dose of vantictumab is above the target efficacious dose based on minimally passaged human tumor xenograft models. Vantictumab shows pharmacodynamic (PD) effects on the WNT-pathway in patient samples in the Phase 1 clinical trial. Evidence of single-agent activity of vantictumab is noted in several patients with neuroendocrine tumors (NETs). Based on these clinical results and data from preclinical patient-derived tumor models, OncoMed is initiating Phase 1b clinical trials in three tumor indications to study its safety in combination with standard-of-care chemotherapy. Vantictumab is part of OncoMed's Wnt pathway collaboration with Bayer Pharma AG.

Jakob Dupont, M.D., OncoMed's Chief Medical Officer commented, "We are encouraged that vantictumab can be administered safely in this study to patients at doses above the target efficacious doses extrapolated from our preclinical models. These results enable the advancement of vantictumab to three Phase 1b trials later this year."

"With ongoing clinical trials with five novel drug candidates in two key pathways, Notch and WNT, OncoMed is leading the way in the development of anti-cancer stem cell therapies," said Paul J. Hastings, Chairman and Chief Executive Officer of OncoMed.

Vantictumab is a first-in-class antibody that has broad anti-cancer stem cell and anti-tumor activity in patient-derived xenograft tumor models. The poster, entitled "A Phase Ia study in patients with advanced solid tumors for the human monoclonal antibody vantictumab (OMP-18R5; anti-Frizzled) targeting the WNT pathway," (Abstract P085) was presented by David Smith, M.D., at the University of Michigan Cancer Center at Ann Arbor, MI, on behalf of the other principal investigators (Lee Rosen, M.D., at the University of California, Los Angeles, CA, and Kyriakos Papadopoulos, M.D. at The START Center for Cancer Care, San Antonio, TX) and the entire study team.

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. Vantictumab is currently in Phase 1. 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 is a clinical-stage company focused on discovering and developing novel therapeutics targeting cancer stem cells.  OncoMed has five anti-cancer product candidates in clinical development, including demcizumab (Anti-DLL4, OMP-21M18), OMP-59R5 (Anti-Notch2/3), OMP-52M51 (Anti-Notch1), vantictumab (Anti-FZD7, OMP-18R5) and OMP-54F28 (Fzd8-Fc), which target key cancer stem cell signaling pathways including Notch and Wnt.  OncoMed has two other antibodies in preclinical development with Investigational New Drug filings planned for 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 1 trials and a favorable safety profile for vantictumab; the potential of vantictumab to improve patient outcomes, particularly in patients with neuroendocrine tumors; 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

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