OncoMed Pharma Begins Third Phase 1b Clinical Trial For OMP-54F28

(RTTNews) - OncoMed Pharmaceuticals Inc. (OMED) announced the initiation of patient treatment for its third multi-center Phase 1b clinical trial of OMP-54F28 (Fzd8-Fc) with carboplatin and paclitaxel in patients with platinum-sensitive ovarian cancer. OMP-54F28 is a first-in-class decoy receptor targeting the Wnt pathway and is part of OncoMed's collaboration with Bayer Pharma AG.

With the commencement of this clinical study, all six of OncoMed's planned Phase 1b clinical trials for its proprietary Wnt-pathway-targeting compounds, vantictumab (OMP-18R5) and OMP-54F28, are now enrolling patients.

Earlier this year OncoMed initiated two separate Phase 1b clinical trials of OMP-54F28 with nab-paclitaxel (Abraxane) and gemcitabine in pancreatic cancer, and with sorafenib (Nexavar) in hepatocellular cancer. During the fourth quarter of 2013, OncoMed initiated three Phase 1b trials for its anti-Frizzled antibody, vantictumab; in combination with paclitaxel in breast cancer, with nab-paclitaxel and gemcitabine in pancreatic cancer, and with docetaxel in non-small cell lung cancer.

The Phase 1b clinical trial of OMP-54F28 in combination with carboplatin and paclitaxel is a dose-escalation study in patients with recurrent platinum-sensitive ovarian cancer. Primary objectives of the trial are to evaluate safety of this combination regimen and determine a recommended Phase 2 dose for OMP-54F28 in combination with carboplatin and paclitaxel. Key secondary and exploratory objectives include evaluation of the pharmacokinetics (PK) and pharmacodynamics (PD) of OMP-54F28, as well as the efficacy of this combination. Tumor tissue from patients will be used to explore predictive biomarker hypotheses related to the efficacy of OMP-54F28.

Interim results for the single-agent, first-in-human Phase 1a trial for OMP-54F28 in solid tumor patients were presented at the 2013 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston. Results from the Phase 1a study showed that OMP-54F28 is well tolerated and modulates the Wnt pathway starting at low doses, as evidenced by PD biomarker analysis of hair follicles.