OncoMed Starts Phase 1b Trial Of Wnt-pathway-targeting Antibody Vantictumab

(RTTNews) - OncoMed Pharmaceuticals Inc. (OMED) , a clinical-stage company developing novel therapeutics that target cancer stem cells or CSCs or tumor-initiating cells, announced Friday that it has started a multi-center Phase 1b clinical trial of its first-in-class Wnt-pathway-targeting antibody vantictumab or OMP-18R5 with docetaxel in non-small cell lung cancer or NSCLC.

This trial is the second of three Phase 1b trials for vantictumab that OncoMed expects to initiate this year as part of OncoMed's collaboration with Bayer Pharma AG.

According to the company, the Phase 1b clinical trial is a dose escalation study of the anti-CSC antibody vantictumab in combination with docetaxel in patients with second- and third-line advanced NSCLC. Primary objectives of the trial are to evaluate safety of this combination regimen and determine a recommended Phase 2 dose for vantictumab in combination with docetaxel. Key secondary and exploratory objectives include evaluation of the pharmacokinetics (PK) and pharmacodynamics or PD of vantictumab and the efficacy of this combination. Tumor tissue from patients will be used to explore predictive biomarker hypotheses related to the efficacy of vantictumab.

Recently, OncoMed initiated a Phase 1b study of vantictumab and paclitaxel in HER2 negative breast cancer. Interim results for the single-agent, first-in-human Phase 1a trial for vantictumab in solid tumor patients were reported at the European Cancer Congress or ECC 2013 in Amsterdam, Netherlands in September 2013. Results from the Phase 1a study showed that vantictumab is well tolerated with early evidence of single agent activity. Additionally, clinical biomarker data from the Phase 1a trial indicating PD modulation of the Wnt pathway by vantictumab were presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston, MA in October 2013.