BARCELONA, Spain and REDWOOD CITY, Calif., Nov. 19, 2014 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, presented data today from the company's ongoing Phase 1a clinical trial of anti-Notch1 (OMP-52M51) in patients with certain advanced solid tumors during an oral plenary session at the 26th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics.
The purpose of the anti-Notch1 Phase 1a clinical trial is to determine a maximum tolerated dose and to assess safety, pharmacokinetics, immunogenicity and preliminary efficacy in patients, including patients with tumors overexpressing the Notch1 target as measured by a predictive diagnostic test. Among 31 patients evaluable for safety, anti-Notch1 had a manageable safety profile. The most common adverse event was on-target diarrhea, which was treated with supportive care. A Phase 2 single-agent dose of 1.5 mg/kg every three weeks was established and will be used in an expansion cohort of the Phase 1a trial that will only enroll patients with tumors that overexpress Notch1 as measured by OncoMed's predictive biomarker assay.
"Encouraging data presented today highlight why we are enthusiastic about the anti-Notch1 clinical program. We have successfully identified a single-agent dose and schedule that shows a manageable safety profile as well as early signs of anti-tumor activity," said Jakob Dupont, M.D., OncoMed's Chief Medical Officer. "OncoMed researchers have identified a number of tumor types where Notch1 may be contributing to tumor growth and progression. In this study, we are using a proprietary immunohistochemistry test to assess Notch1 activation status and correlating those results to the drug's activity. We are seeing early signs of anti-tumor activity in several patients, with the most impressive signals observed in patients whose tumors appear to overexpress the activated form of Notch1."
OncoMed researchers utilized an immunohistochemistry (IHC) test to quantify Notch1 receptor activation and identified select tumor types where the prevalence of the biomarker is estimated to occur in at least ten percent of patients. Patients enrolling in the anti-Notch1 Phase 1a clinical trial include these tumor types: HER2-negative breast cancer, esophageal cancer, colorectal cancer, gastric cancer, pancreatic cancer, small cell lung cancer, adenoid cystic carcinoma and cholangiocarcinoma.
Anti-Notch1 demonstrated early signals of single-agent anti-tumor activity in four of the 17 patients evaluable for response at the time of data cut off. Of the four patients to date that demonstrated clinical benefit, three had tumors that tested positive for overexpression of the activated form of Notch1. A partial response as measured by RECIST criteria was achieved in a 28 year-old patient with adenoid cystic carcinoma whose cancer previously progressed after radiation and four lines of systemic treatment. The patient's tumor tested positive using OncoMed's IHC assay for a marker of Notch1 receptor activation. Three other patients achieved stable disease. Of these, two patients showed high levels of Notch1 receptor activation. One of these patients with refractory colorectal cancer whose cancer had progressed through eight prior lines of systemic therapy remained progression free for 294 days.
"While early, these data provide a snapshot of OncoMed's integrated translational research and clinical development expertise. These results are encouraging for the future development of this clinical program," said Paul J. Hastings, OncoMed's Chairman and Chief Executive Officer. "An expansion cohort enrolling biomarker-selected patients in the anti-Notch1 Phase 1a trial is about to begin and will provide greater information about the potential for anti-Notch1 as a single-agent accompanied by our biomarker assay. Data from the Phase 1a will inform future clinical development and may serve as the basis for an opt-in from our partner on this program, GlaxoSmithKline."
These data were presented during the Plenary Session in a presentation titled, "Safety and early evidence of activity of a first-in-human Phase I study of the novel cancer stem cell (CSC) targeting antibody OMP-52M51 (anti-Notch1) administered intravenously to patients with selected solid tumors" (abstract #2) by lead investigator Amita Patnaik, M.D. of the South Texas Accelerated Research Therapeutics (START) center.
OncoMed's anti-Notch1 antibody blocks signaling of Notch, an important cancer stem cell pathway implicated in chemoresistance, tumor angiogenesis and stem cell self renewal, proliferation and differentiation. Anti-Notch1 is being studied in two Phase 1a clinical trials, one in patients with selected advanced solid tumors and one in select hematologic malignancies. The purpose of each Phase 1a clinical trial is to determine a maximum tolerated dose and to assess safety, pharmacokinetics, immunogenicity and preliminary efficacy. Anti-Notch1 is part of OncoMed's collaboration with GSK.
About OncoMed Pharmaceuticals
OncoMed Pharmaceuticals 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), tarextumab (anti-Notch2/3, OMP-59R5), anti-Notch1 (OMP-52M51), vantictumab (anti-FZD7, OMP-18R5), and ipafricept (FZD8-Fc, OMP-54F28), which target key cancer stem cell signaling pathways including Notch and Wnt. In addition, OncoMed has filed an Investigational New Drug (IND) application for its anti-DLL4/anti-VEGF bispecific antibody (OMP-305B83) and plans to file an IND application for anti-RSPO3 (OMP-131R10) in early 2015. OncoMed is also pursuing discovery of additional novel anti-CSC and cancer immunotherapy product candidates. OncoMed has formed strategic alliances with Celgene Corporation, Bayer Pharma AG and
GlaxoSmithKline (GSK). Additional information can be found at the company's website:
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 ability of OncoMed to use its predictive biomarker to select patients who are more likely to respond positively to treatment with anti-Notch1; the ability of OncoMed to advance anti-Notch1 in development; the timing of initiation of the expansion cohort in Phase 1a for anti-Notch1; the efficacy, including single-agent efficacy, of anti-Notch1 in patients with solid tumors, especially tumors overexpressing activated Notch1; the manageability of the safety profile of anti-Notch1; the prevalence of activated Notch1 in certain tumor types; the potential for an opt-in decision by GSK on anti-Notch1 after Phase 1a; and the timing of an Investigational New Drug application filing for OncoMed's anti-RSPO3 antibody. 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 Celgene, GSK and Bayer, for the funding of its partnered programs; OncoMed's ability to raise additional 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2013, filed with the Securities and Exchange Commission (SEC) on March 18, 2014, OncoMed's Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2014, filed with the SEC on May 8, 2014, OncoMed's Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2014, filed with the SEC on August 7, 2014, and OncoMed's Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2014, filed with the SEC on November 4, 2014.
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