REDWOOD CITY, Calif., Jan. 15, 2015 (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 the enrollment of the first biomarker-selected patient in its anti-Notch1 antibody (OMP-52M51) Phase 1a solid tumor clinical trial. The advancement to the predictive biomarker expansion stage triggered a $5 million milestone from OncoMed's partner, GlaxoSmithKline (GSK).
The expansion stage of the anti-Notch1 Phase 1a solid tumor study is enrolling patients whose tumors demonstrate over expression of the activated form of Notch1. Patients' tumors are pre-screened using OncoMed's proprietary immunohistochemistry (IHC) test to determine eligibility. Patients will receive anti-Notch1 at the recommended Phase 2 dose of 1.5 mg/kg every three weeks. The expansion stage of the solid tumor Phase 1a study is expected to enroll at least ten biomarker-selected patients.
"The expansion stage aims to further characterize the safety profile of Anti-Notch1 at the Phase 2 single-agent dose while also exploring the activity of the drug candidate in patients with tumors demonstrating high levels of Notch1 activity," said Jakob Dupont, M.D., OncoMed's Chief Medical Officer. "By utilizing a biomarker-selection strategy, we hope to identify those patients most likely to benefit from the treatment. We anticipate presenting data from this biomarker expansion cohort in 2015."
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 solid tumor types included in the trial are: HER2-negative breast, esophageal, colorectal, gastric, pancreatic, small cell lung, adenoid cystic carcinoma and cholangiocarcinoma, which are all tumor types where over expression of the activated form of Notch1 occurs in at least ten percent of patients. The purpose of the Phase 1a clinical trials is to determine a maximum tolerated dose and to assess safety, pharmacokinetics, immunogenicity and preliminary efficacy.
"We remain focused on making sure that each of our collaborations is meeting its operational and financial objectives," said Paul J. Hastings, OncoMed's Chairman and Chief Executive Officer. "The initiation of the biomarker-selected expansion stage of the anti-Notch1 Phase 1a clinical trial triggers our latest milestone payment of $5 million from our partner, GSK. The expansion cohort also moves this program one step closer to a potential opt-in."
In December 2007, OncoMed and GSK entered into a strategic alliance to develop cancer stem cell antibody therapeutics targeting the Notch signaling pathway. The collaboration is now focused entirely on the development of two product candidates, tarextumab (anti-Notch2/3, OMP-59R5) and anti-Notch1 (OMP-52M51). GSK retains an option to obtain an exclusive license to tarextumab through the completion of certain Phase 2 randomized proof-of-concept clinical trials. With respect to anti-Notch1, GSK retains an early option through the end of certain Phase 1 trials to obtain an exclusive license to the product candidate or a standard option through the end of certain Phase 2 trials. Should GSK choose to opt in to both programs, OncoMed is eligible to receive from GSK aggregate payments of over $600 million combined, including milestones and upfront payments already received, in addition to double-digit royalties on net product sales.
About OncoMed Pharmaceuticals
OncoMed Pharmaceuticals is a clinical-stage company focused on discovering and developing novel therapeutics targeting cancer stem cells (CSCs). OncoMed has six anti-cancer product candidates in clinical development, including demcizumab (anti-DLL4, OMP-21M18), tarextumab (anti-Notch2/3, OMP-59R5), anti-Notch1 (OMP-52M51), anti-DLL4/VEGF bispecific antibody (OMP-305B83), vantictumab (anti-FZD7, OMP-18R5), and ipafricept (FZD8-Fc, OMP-54F28), which each target key cancer stem cell signaling pathways including Notch and Wnt. In addition, OncoMed plans to file an Investigational New Drug 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 advance its anti-CSC product candidates, including anti-Notch1, in development; the success of OncoMed's biomarker selection strategy for its anti-Notch1 program and OncoMed's ability to identify patients most likely to benefit from anti-Notch1 treatment; the number of patients that will be enrolled in the expansion stage of the anti-Notch1 Phase 1a solid tumor clinical trial; OncoMed's ability to achieve future milestones from GSK; the timing of an Investigational New Drug application filing for OncoMed's anti-RSPO3 antibody; and the availability and timing of data from the expansion cohort of OncoMed's anti-Notch1 Phase 1a solid tumor clinical trial. 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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