FDA places partial hold on OncoMed's Fzd8-Fc

OncoMed Pharmaceuticals Inc. (NASDAQ:OMED) said late Wednesday that FDA placed a partial clinical hold on Fzd8-Fc ( OMP-54F28). On Friday, the company halted enrollment and dosing in Phase Ib trials separately evaluating Fzd8-Fc and vantictumab ( OMP-18R5) after observing mild to moderate bone-related adverse events in patients receiving the Wnt pathway inhibitors. After market close on Friday, OncoMed said FDA placed vantictumab on a partial clinical hold (see BioCentury Extra, June 13).

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. ...