On December 11, 2015 OncoMed Pharmaceuticals Inc. (NASDAQ:OMED) reported new data related to the development of a novel predictive biomarker for vantictumab (anti-Fzd7, OMP-18R5) at the San Antonio Breast Cancer Symposium (SABCS) (Press release, OncoMed, DEC 11, 2015, View Source [SID:1234508537]). The presentation at SABCS detailed the identification and validation of a novel six-gene signature assay being evaluated as a predictive biomarker of response to vantictumab plus paclitaxel in the treatment of breast cancer. Vantictumab is being studied in three Phase 1b combination clinical trials, including one with paclitaxel in patients with Her2-negative breast cancer.
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"The research presented today is one example of OncoMed’s efforts to identify biomarkers early and aggressively that can be evaluated alongside our therapeutic candidates in order to optimize treatment regimens and patient outcomes," said John Lewicki, Ph.D. Executive Vice President and Chief Scientific Officer of OncoMed. "In preclinical testing, the six-gene biomarker assay has been strongly predictive of anti-tumor responses to treatment with vantictumab in Her2-negative breast cancers. If these results are corroborated in our ongoing clinical study of vantictumab in breast cancer, it will provide an excellent opportunity to develop a companion diagnostic and tailor vantictumab use to patients with the highest likelihood of benefit."
The six-gene Wnt pathway-related biomarker was identified by using gene expression data from breast cancer xenografts in OncoMed’s patient-derived tumor bank with established in vivo response to vantictumab plus standard-of-care. The six-gene signature was tested in 18 xenograft models and effectively predicted anti-tumor responses to treatment. The biomarker was developed as a robust qPCR assay and validated with repeatability studies conducted across different days and in different labs. Prevalence of the six-gene signature is estimated to be approximately 43 percent in Her2-negative patients. In collaboration with Almac Diagnostics, the assay has been successfully developed and is being deployed in OncoMed’s ongoing Phase 1b study of vantictumab in Her2-negative breast cancer.
These data were presented today in a poster titled Development of a 6-gene qPCR RUO-validated assay as a predictive biomarker for response of vantictumab (OMP-18R5; anti-frizzled) in HER2- breast cancer patients (# P3-07-57) during the "Prognostic and Predictive Factors: Response Predictions — Biomarkers and Other Factors" poster session.
About Vantictumab (anti-Fzd7, OMP-18R5)
Vantictumab is a first-in-class antibody that inhibits a key signaling pathway in cancer, the Wnt pathway by selectively targeting Frizzled receptors 1, 2, 5, 7 and 8. In patient-derived xenograft models, vantictumab has shown broad anti-cancer stem cell and anti-tumor activity. Vantictumab is now being tested in combination with standard-of-care chemotherapy in three Phase 1b clinical trials in: 1) advanced NSCLC (vantictumab + docetaxel); 2) advanced HER2-negative breast cancer (vantictumab + paclitaxel); and 3) advanced pancreatic cancer (vantictumab + gemcitabine + Abraxane). Vantictumab is part of OncoMed’s collaboration with Bayer Pharma AG.
Vantictumab is a novel investigational therapeutics currently being evaluated in ongoing clinical trials. Patients interested in participating in one of OncoMed’s many clinical trials may learn more by calling 1-866-914-7347 or emailing [email protected].