REDWOOD CITY, Calif., April 22, 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, announced that dosing has begun in the randomized Phase 2 clinical trial of demcizumab (anti-DLL4, OMP-21M18) in patients with first-line metastatic pancreatic cancer.
The double-blind, placebo-controlled Phase 2 "YOSEMITE" clinical trial is designed to compare the efficacy and safety of demcizumab combined with standard of care Abraxane® (paclitaxel protein-bound particles for injectable suspension) (albumin bound) plus gemcitabine in patients with first-line metastatic pancreatic cancer. The primary endpoint of the trial is progression-free survival. Secondary endpoints include overall survival, response rate, duration of response, safety, immunogenicity and pharmacokinetics. Approximately 200 patients will be randomized into one of three study arms. Patients in Arm 1 will receive Abraxane plus gemcitabine (standard of care) plus placebo. Patients in Arm 2 will receive standard of care plus one course of demcizumab 3.5 mg/kg every two weeks for 70 days. Patients in Arm 3 will receive standard of care plus a second course of demcizumab following a 100-day wash out period. The Phase 2 trial is being conducted at approximately 50 centers in the U.S., Canada, Europe and Australia.
"Pancreatic cancer is the fourth leading cause of cancer-related deaths in the United States and Europe and continues to represent a high unmet medical need. Our aim with the Phase2 YOSEMITE trial is to assess the potential of enhancing patient benefit by adding demcizumab to the current standard of care of Abraxane plus gemcitabine," said Jakob Dupont, MD, OncoMed's Chief Medical Officer.
"With the start of this second randomized Phase 2 clinical trial for demcizumab, OncoMed is now enrolling patients in four randomized Phase 2 proof-of-concept trials. Data from multiple randomized Phase 2 trials is expected to be available in the 2016-2017 timeframe," said Paul J. Hastings, OncoMed's Chairman and Chief Executive Officer.
As previously disclosed, OncoMed is eligible to achieve a $70 million milestone from Celgene for successful completion of an interim safety analysis associated with the two randomized demcizumab Phase 2 trials (the YOSEMITE study and the DENALI non-small cell lung cancer trial). The safety analysis will be performed by an independent data safety monitoring board (DSMB) using pre-specified safety criteria agreed to in the collaboration agreement and is expected to occur in late 2015/early 2016.
In OncoMed's Phase 1b clinical studies of demcizumab sixty-four patients have been treated with standard of care with demcizumab using the truncated dosing schedule with doses at or above the Phase 2 dose. The majority of these patients have now been followed for greater than 100 days without any moderate-to-severe cardiopulmonary toxicities.
In OncoMed's Phase 1b clinical study of demcizumab in pancreatic cancer, the combination of demcizumab with Abraxane plus gemcitabine, there were 22 evaluable patients nine achieved partial responses and 10 had stable disease as measured by RECIST criteria, resulting in an overall clinical benefit rate of 86 percent. These results were reported at the 2014 European Society for Medical Oncology (ESMO) meeting. OncoMed plans to present final data from the Phase 1b study of demcizumab in pancreatic cancer at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting.
About Pancreatic Cancer
Pancreatic cancer is the fourth leading cause of cancer-related deaths in the United States and Europe. According to the American Cancer Society, each year in the United States there are approximately 49,000 new cases of pancreatic cancer and 41,000 deaths. The majority of patients with pancreatic cancer are diagnosed after their cancer has spread locally and/or metastasized to distant organs. The average life expectancy after the diagnosis of metastatic pancreatic cancer is less than one year.
About Demcizumab (anti-DLL4, OMP-21M18)
Demcizumab is a humanized monoclonal antibody that inhibits Delta-Like Ligand 4 (DLL4) in the Notch signaling pathway. Based on preclinical studies, demcizumab appears to have a multi-pronged mechanism of action: halting cancer stem cell growth and reducing CSC frequency, disrupting angiogenesis in the tumor and potentially augmenting anti-tumor immune response.
OncoMed is enrolling two randomized Phase 2 clinical trials of demcizumab plus standard-of-care in patients with first-line metastatic pancreatic cancer (YOSEMITE) and metastatic non-small cell lung cancer (NSCLC) (DENALI). A Phase 1b/2 trial of demcizumab and paclitaxel in patients with platinum-resistant ovarian cancer is also ongoing. OncoMed has reported data from Phase 1b clinical studies of demcizumab plus standard-of-care in patients with first-line advanced pancreatic cancer and extensive stage non-squamous NSCLC. Demcizumab was well tolerated in combination with standard-of-care therapies and use of a truncated dosing regimen appeared to successfully mitigate risks of moderate-to-severe cardiopulmonary toxicities without negatively impacting anti-tumor activity. In both Phase 1b studies, demcizumab demonstrated encouraging anti-tumor response rates.
Demcizumab is part of OncoMed's collaboration with Celgene Corporation.
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, the most advanced of which are in randomized Phase 2 clinical trials. Demcizumab (anti-DLL4, OMP-21M18), tarextumab (anti-Notch2/3, OMP-59R5), brontictuzumab (anti-Notch1, OMP-52M51), anti-DLL4/VEGF bispecific antibody (OMP-305B83), vantictumab (anti-FZD7, OMP-18R5), and ipafricept (FZD8-Fc, OMP-54F28) each target key cancer stem cell signaling pathways including Notch and Wnt. OncoMed recently filed an Investigational New Drug application for anti-RSPO3 (OMP-131R10), an antibody targeting a third key cancer stem cell signaling pathway called R-spondin-LGR. OncoMed is also pursuing discovery of additional novel anti-CSC and cancer immuno-oncology 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 potential for demcizumab to enhance patient benefit when combined with standard of care, especially for pancreatic cancer patients; OncoMed's ability to achieve the milestone for successful completion of the interim demcizumab safety analysis, and the timing of such analysis; the number of patients that will be enrolled in the YOSEMITE trial; the number and location of sites at which the YOSEMITE trial will be conducted; OncoMed's ability to successfully advance its randomized Phase 2 clinical trials for tarextumab and demcizumab; the timing of availability of results from multiple randomized Phase 2 studies; the timing of the availability and presentation of final data from the Phase1b study of demcizumab in pancreatic cancer; the mechanism of action of demcizumab; and the ability of a truncated dosing regimen for demcizumab to successfully mitigate cardiopulmonary toxicities. 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, 2014, filed with the Securities and Exchange Commission (SEC) on March 12, 2015.
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