OncoMed’s Shares Gain on Lifting of Partial Clinical Hold

OncoMed Pharmaceuticals, Inc.’s (OMED) shares were up 5.7% with the FDA lifting the partial clinical hold on yet another candidate in its pipeline – ipafricept. The company said that the FDA has removed the partial clinical hold on three phase Ib studies on ipafricept (FZD8-Fc, OMP-54F28).

OncoMed and partner Bayer (BAYRY) are jointly evaluating ipafricept in combination with standard-of-care chemotherapy for ovarian cancer (with carboplatin and Taxol), pancreatic cancer (with Gemzar and Abraxane) and liver cancer (with Nexavar).

We remind investors that in Jun 2014 the FDA had placed a partial clinical hold on the phase Ib studies of ipafricept following the company’s announcement that it is halting patient enrollment and dosing with ipafricept. OncoMed took this action on the basis of careful analysis of mild-to-moderate bone adverse events.

The FDA removed the partial clinical hold from the phase Ib studies on ipafricept following its review of a data package on clinical safety and efficacy and revised study protocols submitted by OncoMed.

OncoMed will resume patient enrollment and dosing in the ipafricept study 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.

We remind investors that late last month, the FDA had lifted the partial clinical hold on three phase Ib studies on its oncology candidate, vantictumab. The lifting of the clinical hold by the FDA on the phase Ib studies on ipafricept and vantictumab is a major positive for OncoMed. We expect investor focus to remain on further updates on the status of both programs.

OncoMed holds a Zacks Rank #5 (Strong Sell). Some better-ranked stocks in the biotech sector are Gilead Sciences Inc. (GILD) and Regado Biosciences, Inc. (RGDO). Both carry a Zacks Rank #1 (Strong Buy).

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