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OMP-54F28 (Fzd8-Fc) Program Reaches Dose Escalation Milestone In Phase 1a Clinical Trial; Triggers $15 Million Payment From Bayer Pharma AG

REDWOOD CITY, Calif., Nov. 5, 2013 (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 today that it has earned a $15 million milestone payment from Bayer Pharma AG related to achieving a dose escalation milestone in the Phase 1a clinical trial of OMP-54F28 (Fzd8-Fc). OMP-54F28 is an antagonist of the Wnt pathway, a key cancer stem cell pathway. 

The Phase 1a clinical trial of OMP-54F28 is an open-label dose escalation study in patients with advanced solid tumors. It is designed to assess OMP-54F28 for safety, immunogenicity, pharmacokinetics, biomarkers, and initial signals of efficacy. In the ongoing study, OMP-54F28 has been well tolerated at doses up to 15 mg/kg every three weeks, which is above the target efficacious dose based on OncoMed's preclinical studies in minimally passaged human tumor xenograft models. First-in-human data from the Phase 1a study detailing OMP-54F28 safety, pharmacokinetics, pharmacodynamics and early signs of efficacy were recently presented at the 2013 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston.

Jakob Dupont, M.D., OncoMed's Chief Medical Officer, commented, "OMP-54F28 demonstrates promising tolerability and early signs of potential anti-tumor activity, as well as Wnt pathway modulation in clinical samples. The early clinical data from the OMP-54F28 program indicate that this compound is a distinct and differentiated Wnt pathway antagonist that is ready for later-stage clinical development in combination with standard-of-care chemotherapy and targeted therapy."

"With the contribution of this $15 million milestone payment from Bayer, OncoMed has achieved a total of $33 million in milestone payments this year from our two corporate partners," said Paul J. Hastings, Chairman and Chief Executive Officer of OncoMed Pharmaceuticals. "We look forward to initiating multiple Phase 1b studies for OMP-54F28 in the coming months in parallel with the continued advancement of our four other ongoing anti-cancer stem cell clinical programs."

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