Evidence of Clinical Activity in Patients With Tumors Positive for Predictive Biomarkers of Notch1 Overexpression Using OncoMed's Immunohistochemistry Assay
BARCELONA, Spain and REDWOOD CITY, Calif., Nov. 19, 2014 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, presented data today from the company's ongoing Phase 1a clinical trial of anti-Notch1 (OMP-52M51) in patients with certain advanced solid tumors during an oral plenary session at the 26thEORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics.
The purpose of the anti-Notch1 Phase 1a clinical trial is to determine a maximum tolerated dose and to assess safety, pharmacokinetics, immunogenicity and preliminary efficacy in patients, including patients with tumors overexpressing the Notch1 target as measured by a predictive diagnostic test. Among 31 patients evaluable for safety, anti-Notch1 had a manageable safety profile. The most common adverse event was on-target diarrhea, which was treated with supportive care. A Phase 2 single-agent dose of 1.5 mg/kg every three weeks was established and will be used in an expansion cohort of the Phase 1a trial that will only enroll patients with tumors that overexpress Notch1 as measured by OncoMed's predictive biomarker assay.
"Encouraging data presented today highlight why we are enthusiastic about the anti-Notch1 clinical program. We have successfully identified a single-agent dose and schedule that shows a manageable safety profile as well as early signs of anti-tumor activity," said Jakob Dupont, M.D., OncoMed's Chief Medical Officer. "OncoMed researchers have identified a number of tumor types where Notch1 may be contributing to tumor growth and progression. In this study, we are using a proprietary immunohistochemistry test to assess Notch1 activation status and correlating those results to the drug's activity. We are seeing early signs of anti-tumor activity in several patients, with the most impressive signals observed in patients whose tumors appear to overexpress the activated form of Notch1."
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OncoMed Presents Biomarker-Focused Clinical Data From Phase 1a Trial of Anti-Notch1 (OMP-52M51) in Oral Plenary Session at the 26th EORTC-NCI-AACR Symposium