REDWOOD CITY, Calif., July 2, 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, today announced the issuance of a broad U.S. patent relating to FZD-Fc soluble receptors, including OncoMed's clinical-stage candidate ipafricept (FZD8-Fc, OMP-54F28). The new patent, U.S. Patent No. 8,765,913, includes claims covering certain FZD-Fc compositions of matter, as well as claims covering methods of treating cancer with such soluble receptors. Polynucleotides encoding the claimed FZD-Fc polypeptides and cells producing such polypeptides are also covered.
In addition to the FZD-Fc patent announced today, OncoMed has previously been granted U.S. patents that relate to FZD-Fc soluble receptors including U.S. Patent Nos. 7,723,477 and 8,324,361. Related patents have also issued in Japan and Australia, and OncoMed has filed related applications which are pending in Europe and certain additional foreign countries.
"We expect that this new patent will provide an additional layer of protection for our ipafricept program, as well as further strengthen OncoMed's growing intellectual property position in the Wnt/FZD field," said Paul J. Hastings, OncoMed's Chairman and Chief Executive Officer.
Ipafricept is a fusion protein comprising a portion of the human FZD8 receptor and a human immunoglobulin Fc domain. The product candidate acts as a decoy receptor that inhibits Wnt signaling by binding Wnt ligands that are activators of Wnt signaling. In preclinical studies, FZD8-Fc has demonstrated anti-tumor activity in a variety of patient-derived xenograft models. FZD8-Fc is currently in Phase 1a and 1b clinical development and is part of OncoMed's collaboration with Bayer.
OncoMed presented Phase 1a data from the first-in-human study of ipafricept in refractory solid tumor patients in an oral presentation at the 2014 Annual Meeting of the American Society of Clinical Oncology (ASCO). In 26 refractory patients, single-agent ipafricept was tolerated with mild-to-moderate dysgeusia (taste change), muscle cramps and nausea as the most common adverse events. Additionally, one moderate bone adverse event occurred. Nine of 26 patients achieved disease control for at least 100 days. Later in June, OncoMed voluntarily halted clinical studies of ipafricept as a precautionary measure following some reports of mild-to-moderate bone adverse events. The Division of Oncology Products 1 of the U.S. Food and Drug Administration concurred with OncoMed's actions and placed a partial clinical hold on ipafricept studies. OncoMed plans to submit amended protocols to the FDA incorporating modified dosing regimens, updated risk mitigation measures and revised enrollment criteria. Enrollment and dosing of new patients in the Phase 1b trials are expected to resume once protocol amendments complete the process of review by the FDA and are approved by the study sites' institutional review boards.
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-Notch 2/3, 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. OncoMed has two other antibodies in preclinical development, anti-DLL4/anti-VEGF bispecific (OMP-305B83) and anti-RSPO3 (OMP-131R10), with Investigational New Drug filings planned for late 2014 or early 2015. OncoMed is also pursuing discovery of additional novel anti-CSC product candidates. OncoMed has formed strategic alliances with Celgene Corporation, Bayer Pharma AG and GlaxoSmithKline. 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 scope, validity, enforceability and duration of patent protection afforded by the referenced patents and OncoMed's other intellectual property; OncoMed's ability to successfully enforce its intellectual property and defend it against challenges by third parties; OncoMed's ability to obtain additional patent protection in the U.S. and additional countries; the potential of ipafricept to significantly impact CSCs, cancer treatment and the clinical outcome of patients with cancer; the ability of OncoMed to advance ipafricept in clinical development; the submission and content of amended protocols for the ipafricept Phase 1 trials; the acceptability of OncoMed's amended ipafricept Phase 1 protocols by the Food and Drug Administration and institutional review boards; the resumption of enrollment and dosing of new patients in the ipafricept Phase 1b trials; and the timing of Investigational New Drug filings for OncoMed's anti-RSPO3 and anti-DLL4/Anti-VEGF bispecific. 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, Bayer, and Celgene, 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, and OncoMed's Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2014, filed with the SEC on May 8, 2014.