OncoMed Pharmaceuticals, Inc. (OMED) announced that the FDA has removed the partial clinical hold on the enrollment process in the phase I studies on vantictumab (anti-Fzd7, OMP-18R5).
The company is evaluating vantictumab in combination with standard-of-care chemotherapy in three phase Ib studies for advanced non-small cell lung cancer (:NSCLC), advanced HER2-negative breast cancer and advanced pancreatic cancer. OncoMed’s shares gained 9.9% following the announcement. OncoMed is developing vantictumab with Bayer (BAYRY).
We remind investors that in Jun 2014 the FDA had placed a partial clinical hold on the phase I studies of vantictumab following the company’s announcement that it is temporarily halting patient enrolment and dosing with vantictumab. OncoMed took this action on the basis of careful analysis of mild-to-moderate bone-related adverse events associated with the treatment with vantictumab.
The FDA removed the partial clinical hold from the phase I studies following its review of a data package on clinical safety and efficacy and revised study protocols submitted by OncoMed.
OncoMed will resume patient enrolment and dosing shortly. Under the amended protocol, OncoMed will follow a modified enrolment criteria as well as amend the dosing regimens and risk mitigation measures including increased monitoring and bone protection strategies.
The lifting of clinical hold on the three vantictumab studies by the FDA is a major positive for OncoMed. We expect investor focus to remain on further updates on the status of this program.
OncoMed holds a Zacks Rank #5 (Strong Sell). Some better-ranked stocks in the biotech sector are Amgen Inc. (AMGN) and Regado Biosciences, Inc. (RGDO). Both carry a Zacks Rank #1 (Strong Buy).