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June 13, 2014
17:53 EDTOMEDOncoMed says Phase 1 clinical trials of vantictumab put on partial hold by FDA
OncoMed Pharmaceuticals discussed the vantictumab and Fzd8-Fc Phase 1 Wnt pathway programs with the U.S. FDA. The FDA informed the company that a partial clinical hold has been placed on Phase 1 clinical trials of vantictumab until revised protocols have been submitted and concurred with. The company reported that, according to the FDA, this action is being taken in view of OncoMed's decision to voluntarily halt enrollment and dosing in the ongoing vantictumab Phase 1 trials. The FDA concurred with OncoMed's plan to continue dosing of a patient in the single-agent Phase 1a vantictumab clinical trial who has remained on treatment for greater than 700 days progression free without significant drug-related adverse effects. The FDA also concurred with OncoMed's plan to continue dosing a patient in the single-agent Phase 1a Fzd8-Fc clinical trial who has remained on treatment for greater than 390 days progression free without significant drug-related adverse effects. "As we announced this morning, we are analyzing the data in hand with the investigators and academic bone expert advisors to assess the adverse events observed in these trials and develop revised clinical trial protocols. Today's discussion with the FDA advanced the process to determine the best path forward. We remain committed to evaluating vantictumab and Fzd8-Fc as possible therapies for cancer patients," stated Paul J. Hastings, Chairman and CEO of OncoMed.
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July 28, 2015
08:51 EDTOMEDOncoMed initiates Phase 1 clinical trial for Anti-RSPO3 antibody
OncoMed Pharmaceuticals announced dosing of the first patient in its anti-RSPO3 antibody Phase 1a/1b clinical trial. Anti-RSPO3 is the first drug in its class to target the R-spondin-LGR pathway, an important cancer stem cell pathway identified by OncoMed researchers. The Phase 1a/1b clinical trial is initially enrolling patients with advanced refractory solid tumors. Patients will receive escalating doses of anti-RSPO3 until disease progression. The open-label study is designed to assess the safety, pharmacokinetics, pharmacodynamics and initial evidence of efficacy of the anti-RSPO3 antibody. Once a single-agent dose has been identified, biomarker-selected patients will be enrolled in a Phase 1a expansion arm to obtain additional preliminary information on possible anti-tumor activity. In the Phase 1b portion of the trial, anti-RSPO3 will also be tested in second-line colorectal cancer patients in combination with the chemotherapeutic standard of care in metastatic colon cancer, known as FOLFIRI. The trial is being conducted at five sites in the United States.

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