FDA lifts partial hold on OncoMed's vantictumab

OncoMed Pharmaceuticals Inc. (NASDAQ:OMED) said FDA lifted a partial hold on the company's Phase Ib trials of vantictumab ( OMP-18R5), a human HuCAL mAb targeting the Wnt signaling pathway. The agency placed the hold after the company halted the trial due to mild to moderate bone-related adverse events. According to OncoMed, FDA lifted the partial hold following a review of safety and efficacy data and revised study protocols submitted by the company with modified dosing regimens, risk mitigation measures, and modified enrollment criteria. OncoMed said FDA's partial hold of Fzd8-Fc ( OMP-54F28), which also targets the Wnt pathway, is still in place.

OncoMed closed up $1.95 to $21.58 on Thursday on the news. Despite the move, the company is still below its close of $24.90 on June 12, before it halted enrollment and dosing in trials of vantictumab and Fzd8-Fc (see BioCentury Extra, June 13). ...