REDWOOD CITY, Calif., Jan. 5, 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 dosing of the first patient in its anti-DLL4/VEGF bispecific antibody (OMP-305B83) Phase 1a clinical trial. The anti-DLL4/VEGF bispecific antibody is designed to have both anti-cancer stem cell and anti-angiogenic activity.
"This is the sixth novel product candidate discovered by OncoMed researchers and the second product from our multi-billion dollar collaboration with Celgene to be advanced to the clinic by our development team," said Paul J. Hastings, OncoMed's Chairman and Chief Executive Officer. "This antibody leverages the clinical experience gained with our anti-DLL4 antibody, demcizumab, which has demonstrated encouraging early signs of clinical activity in Phase 1b clinical trials."
Jakob Dupont, M.D., OncoMed's Chief Medical Officer, added, "The combined inhibition of DLL4 and VEGF with this bispecific has demonstrated robust preclinical activity against a number of solid tumor types. In this trial, we look forward to establishing a suitable dose and exploring this antibody's safety and initial efficacy. We also plan to advance this bispecific antibody to Phase 1b trials, in combination with standard of care in select solid tumors."
The single-agent Phase 1a trial is enrolling patients with advanced refractory solid tumors. The open-label dose-escalation study is designed to assess the safety, pharmacokinetics, pharmacodynamics and initial evidence of efficacy of the anti-DLL4/VEGF bispecific antibody. The trial is being conducted at four sites in the United States.
The bispecific antibody was discovered using OncoMed's proprietary MAbTrap™ antibody display technology, which enables the rapid identification of monoclonal antibodies that bind targets with high affinity and specificity. The antibody is the first program based on OncoMed's BiMAb™ bispecific platform technology, which enables bispecific antibodies with traditional antibody shape, to enter clinical testing. In preclinical studies OncoMed's anti-DLL4/VEGF bispecific antibody demonstrated robust in vivo anti-tumor efficacy across a range of solid tumor xenografts, including colon, lung and pancreatic cancers, among others. The bispecific antibody delayed tumor recurrence following termination of chemotherapy, and decreased the frequency of cancer stem cells. Further, dual inhibition of DLL4 and VEGF appears to exhibit synergistic anti-tumor activity at doses where blockade of either target alone elicited sub-optimal activity.
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. OncoMed plans to file an Investigational New Drug application in early 2015 for anti-RSPO3 (OMP-131R10), an antibody targeting a third key cancer stem cell signalling pathway called R-spondin-LGR. 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 anti-cancer stem cell activity and anti-angiogenic activity of OncoMed's anti-DLL4/VEGF bispecific (OMP-305B83); the anti-tumor efficacy of OMP-305B83 against a range of solid tumors, including colon, lung, and pancreatic cancers; the potential for dual inhibition of DLL4 and VEGF to exhibit synergistic anti-tumor activity at doses where blockade of either target alone elicits sub-optimal activity; the ability of OncoMed to establish a suitable dose for OMP-305B83; 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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