OncoMed Starts Phase 1b Clinical Trial For OMP-54F28

OncoMed Pharmaceuticals, Inc. announced in a press release that it has initiated a Phase 1b clinical trial of OMP-54F28 (Fzd8-Fc). OMP-54F28 is indicated for ovarian cancer. The agent is a decoy receptor that targets the Wnt pathway. Investigators plan to use it with carboplatin and paclitaxel. The drug discovery process is shared with Bayer Pharma AG (Bayer). Paul J. Hastings, OncoMed's Chairman and Chief Executive Officer said, "With the initiation of our Phase 1b study of OMP-54F28 in ovarian cancer, we have now achieved our goal of six open Phase 1b combination trials for our two anti-cancer stem cell clinical candidates that target the Wnt pathway." He added that OMP-54F28 and another drug, vantictumab, show positive early results.

Ovarian Cancer

Ovarian cancer is a malignancy that originates in a woman’s ovaries, the reproductive glands that produce eggs. Ovaries produce the hormones progesterone and estrogen. Researchers are targeting the cancer stem cells (CSC), the ones responsible for the growing tumor. These CSCs are also known as tumor-initiating cells. Current cancer drugs have little effect on CSCs so tumors often grow back.    

OMP-54F28

OMP-54F28 is effective on CSCs as it targets the cell’s self-renewal process and instigates non-tumorigenic differentiation. The action mechanism of CSC agents is distinct from current therapies like chemotherapy. The agent is a fusion protein with an extracellular ligand-binding domain. It binds Wnt ligands selectively to influence Wnt signaling.   

Phase 1b Clinical Trials of OMP-54F28

With the start of this study, OncoMed has six clinical trials underway for its Wnt-pathway-targeting compounds. In 2013, three Phase 1b trials started: vantictumab  with paclitaxel in breast cancer, vantictumab with nab-paclitaxel and gemcitabine, and vantictumab with docetaxel. Early this year, two trials started, OMP-54F28 (with nab-paclitaxel and gemcitabine) and OMP-54F28 (with sorafenib). OMP-18R5 and OMP-54F28 are enrolling patients.  

Trial objectives are to evaluate the pharmacokinetic profile and better understand the pharmacodynamics because the agents are combined with other drugs. Investigators will look at safety issues and determine an effective dose. Scott McMeekin, M.D. of the University of Oklahoma is the principal investigator and he treated the first patient in the study. Additional investigators and sites include:

• Gina Mantia-Smaldone, M.D., Fox Chase Cancer Center, Philadelphia, PA
• Paul Sabbatini, M.D., Memorial Sloan-Kettering Cancer Center, New York, NY
• Nelson Teng, M.D., Stanford University, Palo Alto, CA

Source:

http://investor.shareholder.com/oncomed/releasedetail.cfm?ReleaseID=827061