OncoMed Pharmaceuticals Inc. (NASDAQ:OMED) fell as much as $6.15 (25%) on Friday before closing the day off $2.19 to $22.71 after halting enrollment and dosing in Phase Ib trials evaluating the company's two Wnt pathway inhibitors to treat cancer. The move came as a result of mild to moderate bone-related adverse events in open-label, dose-escalation trials separately evaluating vantictumab (OMP-18R5) and Fzd8-Fc (OMP-54F28) in combination with other therapies. After market close, OncoMed said FDA placed the trials on a partial clinical hold.
OncoMed said the AEs were grade 1/2 fractures in line with the type seen with chemotherapies like tamoxifen and aromatase inhibitors. The company submitted amended protocols to FDA and the study sites' institutional review boards. The amendments include modified dosing regimens and updated risk mitigation measures.
Vantictumab is in Phase Ib trials for untreated pancreatic cancer, locally advanced or metastatic HER2-negative breast cancer and as second- and third-line treatment of advanced non-small cell lung cancer (NSCLC). Fzd8-Fc is in Phase Ib trials for recurrent platinum-sensitive ovarian cancer, previously untreated pancreatic cancer and as first-line treatment of locally advanced or metastatic hepatocellular carcinoma (HCC).
OncoMed and Bayer AG (Xetra:BAYN) are partnered to discover and develop antibodies, proteins and small molecules targeting the Wnt signaling pathway for cancer. Under the 2010 deal, Bayer has an option to exclusively license vantictumab and Fzd8-Fc at any point up to the completion of Phase I testing.
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