OncoMed Doses First Patient with GITRL-Fc in Phase 1a Clinical Trial

REDWOOD CITY, Calif., Sept. 13, 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 GITRL-Fc (OMP-336B11).  GITRL-Fc is an investigational immuno-oncology therapeutic candidate designed to leverage the natural trimeric ligand to modulate the tumor microenvironment by inhibiting T-regulatory cells and activating T-effector cells.

“The 1st generation immuno-oncology agents, which work by blocking the activation of inhibitory receptors on T cells, have produced impressive results in a number of tumor types,” said Kyriakos Papadopoulos, M.D. at South Texas Accelerated Research Therapeutics (START) in San Antonio, TX and a lead investigator for the Phase 1a study. “GITRL-Fc is designed to directly agonize the GITR T cell activation receptor, resulting in increased T-effector cells and a reduction in the number of T-regulatory cells. OncoMed’s agent has demonstrated anti-tumor activity in pre-clinical studies, and as a result, we are excited to initiate this Phase 1a clinical trial of GITRL-Fc.”

The Phase 1a open-label clinical trial is designed to assess the safety and tolerability of escalating doses of GITRL-Fc in patients with advanced or metastatic solid tumors. Secondary objectives for the trial include characterization of the pharmacokinetics, immunogenicity and anti-tumor efficacy.  Pharmacodynamic and potential predictive biomarkers focused on changes in immune system activation will also be explored. GITRL-Fc 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.

“GITRL-Fc is a fusion protein consisting of the fully human natural trimer GITR ligand linked to an Fc.  Pre-clinical experiments have suggested that this agent may be a more potent agonist of the GITR trimer receptor than bivalent agonist antibodies,” said Robert Stagg, Pharm.D., OncoMed’s Senior Vice President of Clinical Research and Development. “As a result, we are very pleased to have initiated this Phase 1a trial which will help to define the maximum tolerated dose, safety and preliminary efficacy of this immuno-oncology agent.”

About GITRL-Fc
GITR (glucocorticoid-induced TNFR-related protein) is a costimulatory molecule that has been shown to be involved in inhibiting the suppressive activity of T-regulatory cells and extending the survival of T-effector cells. Leveraging OncoMed’s proprietary linkerless gene trimer technology, OncoMed has developed a differentiated approach to targeting the GITR/GITRL axis by creating a fusion protein with an Fc-linked fully human trimer ligand that may be more amenable to the natural receptor’s trimeric structure. GITRL-Fc is designed to modulate the tumor microenvironment by inhibiting T-regulatory function and activating T-effector cells. In preclinical studies, a surrogate GITRL-Fc showed superior GITR signaling activation, T-cell proliferation and cytokine production in human T-cell models as compared to two anti-GITR mAbs in competitive development and demonstrated potent in vivo anti-tumor activity. GITRL-Fc is currently being studied in a Phase 1a study in patients with solid tumors. OncoMed is independently developing GITRL-Fc. 

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.  Navicixizumab (anti-DLL4/VEGF bispecific, OMP-305B83), rosmantuzumab (anti-RSPO3, OMP-131R10) and anti-TIGIT (OMP-313M32) are part of the company’s strategic alliance with Celgene Corporation.  OncoMed is independently developing GITRL-Fc (OMP-336B11), as well as continuing to pursue new drug discovery research.  OncoMed is also evaluating potential partnering opportunities for vantictumab (anti-Fzd, OMP-18R5) and ipafricept (Fzd8-Fc, OMP-54F28).  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 GITRL-Fc to modulate the tumor microenvironment by inhibiting T-regulatory cells and activating T-effector cells; the possibility of OncoMed’s GITRL-Fc being a more potent GITR agonist than bivalent agonist antibodies; and the size of the Phase1a GITRL-Fc 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; 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, OncoMed’s Quarterly Report on Form 10-Q filed with the SEC on August 2, 2017, and OncoMed’s other current and periodic reports filed with the SEC.

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