FDA lifts a hold on one of OncoMed's cancer drug programs

Shares of OncoMed Pharmaceuticals ($OMED) took a nasty tumble a couple of months ago when it hit the brakes on a pair of early-stage programs for two of its treatments after investigators noted trouble with some bone-related adverse events. Today, the biotech says it adjusted its protocols on vantictumab, a Wnt pathway inhibitor program, to the satisfaction of the FDA, which lifted its partial hold on the program.

There wasn't much of a pop on the stock side this morning, though, with shares up only 2% shortly after the news hit. The stock had already climbed back, though, recovering much of the loss from the initial setback.

The clinical trial hold was lifted after the company modified dosing regimens, set up risk mitigation measures--including increased monitoring and bone protection strategies--and modified its enrollment criteria. Vantictumab combined with a standard chemo therapy are now in three Phase Ib trials in non-small cell lung cancer, HER2-negative breast cancer and pancreatic cancer. 

If these studies are positive, Bayer has the rights to opt in on the programs. The pharma company signed up for a $430 million partnership in 2010, paying $40 million upfront for the right to buy in to up to 5 drug candidates.

Jakob Dupont

"The revised protocols were developed with input from the vantictumab clinical investigators and academic bone experts and are intended to mitigate the risks of future adverse events as we seek an optimal efficacious dose to take forward in the development of this first-in-class WNT pathway inhibitor," noted Jakob Dupont, OncoMed's chief medical officer, in a statement. 

- here's the release

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