Updated Phase 1b Data for Demcizumab in Non-Small Cell Lung and Pancreatic Cancers
First Public Presentation of Clinical Data From Ongoing Phase 1 Trials for Anti-Notch1 and Fzd8-Fc Programs
Updated Pharmacodynamic Data for the Vantictumab Program
REDWOOD CITY, Calif., Oct. 14, 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 five abstracts had been accepted as poster presentations at the upcoming AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, October 19-23, 2013 at the Hynes Convention Center in Boston, MA.
These five posters contain results from four of OncoMed's five clinical stage product development candidates. Two of the five posters represent the first public presentations of clinical data from two novel anti-CSC agents: anti-Notch1 (OMP-52M51), an antibody targeting the Notch1 receptor and inhibiting signaling through this important target in the Notch CSC pathway, and Fzd8-Fc (OMP-54F28), a fusion protein binding Wnt ligands and inhibiting the key Wnt CSC pathway. The titles and timing of the five poster presentations are:
1.Title: A Phase 1b study of demcizumab (DEM, anti-DLL4) plus pemetrexed and carboplatin in patients with 1st line stage IIIb/IV non-squamous non-small cell lung cancer Presenting Author: Dr. Jakob Dupont, CMO, OncoMed, Redwood City, CA Session ID: Poster Session A Session Title: Clinical Trials Session Date and Time: Sunday, Oct. 20, 2013 12:30 PM - 7:30 PM EST Location: Exhibit Hall C-D Permanent Abstract Number: A71 2.Title: A first-in-human Phase 1 study of the novel cancer stem cell (CSC) targeting antibody OMP-52M51 (anti-Notch1) administered intravenously to patients with certain advanced solid tumors Presenting Author: Dr. S. Lindsey Davis, U. of Colorado-Denver, Aurora, CO Session ID: Poster Session B Session Title: Cancer Stem Cells Session Date and Time: Monday,Oct 21, 2013 12:30 PM - 7:30 PM EST Location: Exhibit Hall C-D Permanent Abstract Number: B48 3.Title: A Phase Ib study of demcizumab (DEM, anti-DLL4) with gemcitabine (GEM) in patients with first line locally advanced or metastatic pancreatic cancer Presenting Author: Dr. Antonio Cubillo, START, Madrid, SP Session ID: Poster Session B Session Title: Clinical Trials Session Date and Time: Monday, Oct. 21, 2013 12:30 PM - 7:30 PM EST Location: Exhibit Hall C-D Permanent Abstract Number: B78 4. Title: A first-in-human Phase 1 study of anti-cancer stem cell (CSC) agent OMP-54F28 (FZD8-Fc) targeting the WNT pathway in patients with advanced solid tumors Presenting Author: Dr. David Smith, University of Michigan, Ann Arbor, MI Session ID: Poster Session B Session Title: Clinical Trials Session Date and Time: Monday, Oct. 21, 2013 12:30 PM - 7:30 PM EST Location: Exhibit Hall C-D Permanent Abstract Number: B79 5. Title: Biomarker analysis in the first-in-human Phase 1a study for vantictumab (OMP-18R5; anti-Frizzled) demonstrates pharmacodynamic (PD) modulation of the Wnt pathway in patients with advanced solid tumors. Presenting Author: Dr. Ann Kapoun, VP Translational Medicine, OncoMed, Redwood City, CA Session ID: Poster Session B Session Title: Biomarkers Session Date and Time: Monday, Oct. 21, 2013 12:30 PM - 7:30 PM EST Location: Exhibit Hall C-D Permanent Abstract Number: B24
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 Demcizumab (OMP-21M18)
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 and pancreatic cancer Phase 1b trials will be presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston, MA, in October 2013. In addition, a Phase 1b/2 trial of demcizumab and paclitaxel in patients with platinum-resistant ovarian cancer is ongoing at MD Anderson Cancer Center. OncoMed has worldwide rights to this program.
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 1a. 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 will be presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston, MA, in October 2013. Vantictumab is part of OncoMed's collaboration with Bayer Pharma AG.
About Anti-Notch1 (OMP-52M51)
Anti-Notch1 is a first-in-class antibody that has shown broad anti-CSC and anti-tumor activity in specific patient-derived xenograft tumor models. Anti-Notch1 inhibits a key signaling pathway in cancer, the Notch pathway. Specifically, anti-Notch1 selectively targets the Notch1 receptor and prevents signaling through this important Notch receptor. 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 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. Data from the anti-Notch1 refractory solid tumor trial will be presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston, MA, in October 2013. Anti-Notch1 is part of OncoMed's collaboration with GlaxoSmithKline.
About Fzd8-Fc (OMP-54F28)
Fzd8-Fc is a first-in-class fusion protein that has shown broad anti-CSC and anti-tumor activity in patient-derived xenograft tumor models. Fzd8-Fc inhibits a key signaling pathway in cancer, the Wnt pathway. Specifically, Fzd8-Fc consists of the extracellular ligand-binding domain of the Frizzled 8 receptor and the Fc domain of a human IgG1 antibody. Fzd8-Fc selectively binds Wnt ligands, which are activators of Wnt signaling. Fzd8-Fc is currently in Phase 1a in patients with refractory solid tumors. Data from the Fzd8-Fc solid tumor trial will be presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston, MA, in October 2013. Fzd8-Fc is part of OncoMed's collaboration with Bayer Pharma AG.
About OncoMed Pharmaceuticals
OncoMed Pharmaceuticals Inc. (Nasdaq:OMED), 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), OMP-59R5 (Anti-Notch2/3), OMP-52M51 (Anti-Notch1), vantictumab (Anti-Fzd7, OMP-18R5), 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 1 trials for demcizumab, vantictumab, anti-Notch1 and Fzd8-Fc and a favorable safety profile for these drug candidates; 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.