First Presentation of First-in-Human Trial of Anti-Notch1 (OMP-52M51) Suggests This Antibody Can be Given Safely With Early Suggestion of Efficacy in Patients With Certain Advanced Solid Tumors Demcizumab (Anti-DLL4) Can be Safely Combined With Gemcitabine Chemotherapy for Pancreatic Cancer With Encouraging Early Efficacy Data First Presentation of First-in-Human Trial of Frizzled8 Fusion Protein (OMP-54F28) Suggests the Drug Candidate Can be Safely Given With Evidence of Wnt-Pathway Targeting and Early Suggestion of Efficacy in Patients With Certain Advanced Solid Tumors Clinical Pharmacodynamic Data for First-in-Class Anti-Frizzled Antibody Vantictumab Demonstrate Modulation of the Wnt Pathway in Tumors and Surrogate Tissues REDWOOD CITY, Calif., Oct. 21, 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 data for four of its five clinical-stage programs at poster sessions at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics , October 19-23, 2013, at the Hynes Convention Center in Boston, MA. Anti-Notch1 Poster Dr. Lindsey Davis, from the University of Colorado-Denver, Aurora, CO, presented the first public unveiling of the first-in-human Phase 1a data for OMP-52M51, a first-in-class anti-Notch1 antibody [ Poster B48, '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']. OMP-52M51 has been well tolerated thus far with the main target-mediated toxicity of diarrhea. Other related adverse events have included nausea, fatigue and rash. There is biomarker evidence of circulating tumor cell reduction with OMP-52M51 treatment, as well as early potential efficacy in two subjects, one with metastatic colorectal cancer and one with metastatic HER2 negative breast cancer. Dose escalation is continuing, and an expansion cohort for patients with tumors that have Notch1 activation is planned. Demcizumab (anti-DLL4) Poster Dr. Antonio Cubillo from START-Madrid, Madrid, Spain, presented Phase 1b data in pancreatic cancer for demcizumab, a humanized monoclonal antibody that inhibits Delta-Like Ligand 4 (DLL4) in the Notch signaling pathway [ Poster B78, 'A Phase Ib study of demcizumab (DEM, anti-DLL4) with gemcitabine (GEM) in patients with first-line locally advanced or metastatic pancreatic cancer']. The combination of demcizumab and gemcitabine was generally well tolerated. The most common demcizumab-related adverse events were: fatigue, manageable hypertension, nausea and vomiting. Observed toxicities were consistent with the single-agent safety profiles, and no new safety signals emerged. Demcizumab-related reversible cardiotoxicity appeared to be successfully prevented and managed through regular monitoring, a truncated treatment approach and cardioprotective medication, if indicated. The efficacy data from the study suggested early efficacy with a RECIST partial response rate of 25% and a stable disease rate of 44% for an overall clinical benefit rate of 69% for patients receiving demcizumab and gemcitabine across the dose cohorts. The cohort of patients receiving demcizumab at 5mg/kg every 3 weeks with gemcitabine had a median progression-free survival of 176 days. The combination of demcizumab (dosed in a truncated fashion to day 70) with gemcitabine and nab-paclitaxel is currently being evaluated in this trial, and a randomized Phase 2 trial in first-line stage IV pancreatic cancer is planned for 2014. FZD8-Fc Poster Dr. David Smith from University of Michigan, Ann Arbor, MI, presented the first public presentation of the first-in-human Phase 1a trial for OMP-54F28 (FZD8-Fc), a first-in-class fusion protein [ Poster B79, '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']. OMP-54F28 consists of part of the Frizzled8 receptor fused to the Fc domain of a human IgG1 antibody. The drug product inhibits the Wnt pathway by binding Wnt ligand. In the ongoing Phase 1a trial, OMP-54F28 was administered to refractory solid tumor patients. The drug product was well tolerated, and dose escalation continues. The most common OMP-54F28 related adverse events were: decreased appetite, muscle spasms, nausea, and dysgeusia (altered taste sensation). There were rare changes in bone turnover markers that were easily managed with the bone risk mitigation plan on the study. Biomarker evaluations revealed Wnt pathway modulation with OMP-54F28 treatment in patient hair follicles. Potential early efficacy manifested by prolonged disease control was noted in two patients with Desmoid Tumors and a patient each with renal cell and pancreatic cancer. The clinical data enable initiation of three Phase 1b trials in late 2013 to early 2014. Vantictumab Biomarker Poster Dr. Ann Kapoun, Vice President of Translational Medicine at OncoMed, presented pharmacodynamic biomarker data for the first-in-human Phase 1a trial of vantictumab (OMP-18R5), a first-in-class anti-Frizzled antibody targeting the Wnt pathway [ Poster B24, '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']. Pharmacodynamic effects of vantictumab were observed in tumor biopsies, hair follicles and blood. The effects were consistent with inhibition of the Wnt pathway, were observed starting at a dose of 0.5 mg/kg and extended beyond serum exposure. Dr. Jakob Dupont, OncoMed's Chief Medical Officer, commented, "All five of OncoMed's clinical programs are successfully moving toward the next stages of development. The trials are revealing that these novel anti-cancer stem cell product candidates have distinct safety profiles. We are also seeing biomarker evidence of key CSC pathway modulation and potentially early signs of efficacy in patients. It is particularly exciting that we have now have evidence from two Phase 1b trials that demcizumab can be safely combined with chemotherapy."
Paul J. Hastings, Chairman and Chief Executive Officer of OncoMed, commented, "We are pleased to share these clinical and biomarker data from 4 of our 5 clinical-stage drugs suggesting single and combination agent safety, and early signs of efficacy. All five of our clinical programs are in excellent positions to take the next step toward randomized proof-of-concept studies."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 were 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 were 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 potential 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 were 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 were 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 PharmaceuticalsOncoMed 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 (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, anti-Notch2/3 and Fzd8-Fc and a favorable safety profile for these drug candidates; the successful advancement of OncoMed's product candidates to randomized proof-of-concept trials; 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, in particular, the timing of the initiation of a Phase 2 trial in pancreatic cancer for demcizumab and Phase 1b trials for Fzd8-Fc. 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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