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OncoMed Pharmaceuticals Initiates Phase 1b/2 Clinical Trial of Demcizumab (Anti-DLL4) in Combination with Paclitaxel in Ovarian Cancer

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REDWOOD CITY, Calif., Sept. 19, 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 Phase 1b/2 clinical trial of its anti-cancer stem cell product candidate, demcizumab (OMP-21M18) in ovarian cancer. The trial will enroll patients at the MD Anderson Cancer Center in Houston, TX, and is being funded in part under an ovarian cancer National Cancer Institute SPORE Grant Program.

In this Phase 1b/2 trial, demcizumab is being tested in combination with paclitaxel in patients with platinum-resistant ovarian cancer, fallopian tube cancer or primary peritoneal cancer. Following a Phase 1b safety run-in, a Phase 2 clinical trial will proceed in these patients. The primary endpoints of the Phase 2 part of the trial will be to determine the progression-free survival and response rate of the novel demcizumab with paclitaxel combination. Key secondary and exploratory endpoints include overall survival, biomarker endpoints and safety.

Dr. Robert Coleman, Professor & Vice Chair, Clinical Research, Department of Gynecologic Oncology and Reproductive Medicine at The University of Texas MD Anderson Cancer Center in Houston, TX, and the Principal Investigator who treated the first patient on the study noted, "Women with platinum-resistant ovarian, fallopian tube and primary peritoneal cancers are in need of new treatment options. We believe that an investigational therapy such as demcizumab, with its novel anti-cancer stem cell mechanism of action, could yield important results for these patients."

"The trial includes a number of translational science and biomarker evaluations that will help to elucidate the mechanisms by which demcizumab works for the treatment of ovarian cancer patients and aims to identify predictors of response to therapy," said Dr. Anil Sood, Professor & Vice Chair, Translational Research in the Department, who will be working on the trial.

The trial is OncoMed's fourth Phase 1b trial of demcizumab, and the second portion of this protocol would represent the first Phase 2 trial of demcizumab. Previous Phase 1b trials combining demcizumab with chemotherapy regimens have been initiated in patients with first-line pancreatic cancer (with gemcitabine and Abraxane™), first- or second-line colorectal cancer (with FOLFIRI chemotherapy) and first-line non-small cell lung cancer (with carboplatin and pemetrexed chemotherapy). The Phase 1b trials in pancreatic cancer and non-small cell lung cancer are currently enrolling patients.

"We believe ovarian cancer is another important cancer indication for the demcizumab clinical program and an area of high unmet medical need," said Dr. Jakob Dupont, Chief Medical Officer of OncoMed. "We have observed strong preclinical efficacy of demcizumab and paclitaxel in patient-derived ovarian cancer xenograft models, as well as early evidence of activity of demcizumab in ovarian cancer in the Phase 1a single-agent study of demcizumab."

Paul Hastings, Chairman and Chief Executive Officer of OncoMed, emphasized, "The ovarian cancer trial provides the earliest opportunity to advance a demcizumab program to Phase 2. As such it will represent a significant advance for this unpartnered anti-cancer stem cell asset."

About Demcizumab

Demcizumab (OMP-21M18) is a humanized monoclonal antibody that inhibits Delta-Like Ligand 4 (DLL4) in the Notch signaling pathway. Two Phase 1b combination trials of demcizumab are ongoing. The first trial is in combination with standard-of care gemcitabine and Abraxane™ in first-line advanced pancreatic cancer patients, and the second trial is in combination with standard of care carboplatin and pemetrexed (Alimta™) in first-line advanced non-small cell lung cancer (NSCLC) patients. Data from the demcizumab NSCLC Phase 1b trial were presented at the EORTC-AACR-NCI Molecular Targets and Cancer Therapeutics Meeting in Dublin, Ireland in November 2012. In addition, a Phase 1b/2 trial of demcizumab and paclitaxel in patients with platinum-resistant ovarian cancer has been initiated. OncoMed has worldwide rights to this program.

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 HealthCare 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 a successful Phase 1b safety-run in for demcizumab and the initiation of the Phase 2 portion of the trial; the potential of demcizumab to improve patient outcomes, particularly in ovarian cancer patients; 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 (SEC) on July 18, 2013 and OncoMed's Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2013, filed with the SEC 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.