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OncoMed Doses First Patient with Anti-TIGIT Antibody in Phase 1 Clinical Trial

REDWOOD CITY, Calif., May 04, 2017 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals Inc. (NASDAQ:OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics, announced today that the first patient has been dosed in the company's Phase 1a clinical trial of anti-TIGIT (OMP-313M32). Anti-TIGIT is an investigational immuno-oncology therapeutic candidate intended to block suppression of the immune system in tumors and enable immune system anti-tumor activity, similar to marketed checkpoint inhibitors that target the PD-L1-PD-1 axis.

"The first wave of immuno-oncology agents demonstrated that disabling immune suppression mechanisms in tumors can enable the body's immune system to fight cancers with good efficacy. Still, available immunotherapies have limited results for many cancer patients, and there remains a pressing need for new agents and combinations to improve outcomes," said Johanna Bendell, M.D., Associate Director of the Drug Development Program at Sarah Cannon Research Institute and a lead investigator for the Phase 1a anti-TIGIT study. "The immuno-suppressive receptor TIGIT is expressed on many different tumor types, giving us reason to believe that an anti-TIGIT antibody, such as OncoMed's OMP-313M32, has potential for broad activity in cancer patients. I look forward to seeing its performance in the clinic."

The Phase 1 open-label clinical trial is designed to assess the safety and tolerability of escalating doses of anti-TIGIT in patients with advanced or metastatic solid tumors. Secondary objectives for the trial include characterization of the pharmacokinetics, immunogenicity and anti-tumor efficacy of single-agent anti-TIGIT. Pharmacodynamic and potential predictive biomarkers focused on changes in immune system activation will also be explored. Anti-TIGIT will be administered as a single agent every two weeks at escalating dose levels. Once a maximum-tolerated dose has been achieved, an expansion cohort will enroll patients with certain tumor types. The trial will be conducted at five centers in the U.S. and is expected to enroll approximately 30 patients.

"In multiple preclinical studies of anti-TIGIT antibodies, we have observed immune activation and single-agent as well as combination anti-tumor activity, including indications that an anti-TIGIT antibody induced a long-term immune memory response." said Robert Stagg, Pharm.D., OncoMed's Senior Vice President of Clinical Research and Development. "The initiation of this Phase 1a anti-TIGIT study represents the first of our novel immuno-oncology therapeutics to enter clinical trials. We believe that by blocking TIGIT signaling, our anti-TIGIT antibody may enable T-cell activation and facilitate anti-tumor immune responses with the potential to impact tumor growth."

About Anti-TIGIT

TIGIT (T cell immunoreceptor with Ig and ITIM domains) blocks T cells from attacking tumor cells and is similar in structure and function to the inhibitory protein PD-1. OncoMed's anti-TIGIT antibody (OMP-313M32) is intended to activate the immune system through multiple mechanisms and enable anti-tumor activity. At the 2017 AACR Annual Meeting, OncoMed presented data from several studies characterizing anti-TIGIT's mechanism, identifying pharmacodynamics biomarkers and demonstrating potent anti-tumor responses in in-vivo models. In preclinical studies, anti-TIGIT antibodies increased cytotoxic T-cell activity against tumor cells and decreased T-cell suppression. A surrogate anti-TIGIT antibody used in syngeneic mouse models of different solid tumors demonstrated dose-dependent, potent single-agent anti-tumor efficacy. Anti-TIGIT antibodies also demonstrated combination activity with checkpoint inhibitors anti-PD1 and anti-PD-L1 in preclinical models. When mice whose tumors achieved complete regression following treatment with anti-TIGIT, anti-TIGIT plus anti-PD1 or anti-TIGIT plus anti-PD-L1 were re-challenged with increasing number of tumor cells, they remained protected from tumor growth, suggesting the induction of immunologic memory against the tumor cells. This program is part of OncoMed's Celgene collaboration.

About OncoMed Pharmaceuticals

OncoMed Pharmaceuticals is a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics. OncoMed has internally discovered a broad pipeline of investigational drugs intended to address the fundamental biology driving cancer's growth, resistance, recurrence and metastasis. Demcizumab (anti-DLL4, OMP-21M18), navicixizumab (anti-DLL4/VEGF bispecific, OMP-305B83), rosmantuzumab (anti-RSPO3, OMP-131R10) and anti-TIGIT (OMP-313M32) are part of the company's strategic alliances with Celgene Corporation. OncoMed is independently developing vantictumab (anti-Fzd, OMP-18R5), ipafricept (Fzd8-Fc, OMP-54F28) and GITRL-Fc (OMP-336B11), as well as continuing to pursue new drug discovery research. For further information about OncoMed Pharmaceuticals, please see 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, without limitation, OncoMed's intentions and expectations regarding the ability of OncoMed's anti-TIGIT antibody to enable T-cell activation, block suppression of the immune system in tumors, facilitate an anti-tumor immune response, and impact tumor growth by blocking TIGIT signaling and/or through other mechanisms; the similarity of anti-TIGIT to marketed checkpoint inhibitors; and the potential for anti-TIGIT to be broadly active and benefit a significant number of patients. 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; OncoMed's dependence on its collaboration partners, including 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 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 discover, develop and commercialize additional product candidates; and OncoMed's dependence on its key executives. 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 filed with the U.S. Securities and Exchange Commission (SEC) on March 9, 2017 and OncoMed's other current and periodic reports filed with the SEC.

Source: OncoMed Pharmaceuticals Inc.

Posted: May 2017

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