FDA Removes Partial Hold On OncoMed's Cancer Drug Clinical Trials

OncoMed Pharmaceuticals has announced the removal of the FDA's partial clinical hold on the Phase 1 clinical trials of the company's cancer drug, ipafricept (FZD8-Fc, OMP-54F28). The company expects enrollment and dosing of new patients to resume within the next few weeks. Ipafricept is being studied in combination with standard treatments in three Phase 1b studies for pancreatic cancer, hepatocellular carcinoma, and platinum-sensitive ovarian cancer.

This marks the second removal of FDA partial hold for the company in the past few weeks. On August 28, the FDA removed the partial clinical hold on enrollment in OncoMed's vantictumab (anti-Fzd7, OMP-18R5) Phase 1 clinical trials. Vantictumab is being studied in combination with chemotherapy in three Phase 1b clinical trials in patients with advanced non-small cell lung cancer (NSCLC), advanced HER2-negative breast cancer and advanced pancreatic cancer.

In mid-June, OncoMed decided to voluntarily halt enrollment in its Phase 1 clinical trials of vantictumab and ipafricept as a precautionary measure based on some unexpected and potentially dangerous side-effects on patients' bones. The FDA subsequently placed the two drugs on partial clinical hold, while allowing for the continued dosing of patients who demonstrated benefit without significant drug-related adverse effects.

The removal of the partial holds follows OncoMed's submission of a clinical safety and efficacy data package for ipafricept and vantictumab, along with revised study protocols to the FDA. The clinical trial amendments include modified dosing regimens, increased monitoring and bone protection strategies, and modified enrollment criteria.

"We expect enrollment in our first-in-class Wnt pathway programs, ipafricept and vantictumab, to be back underway soon," said Paul J. Hastings, Chairman and CEO of OncoMed. "The Wnt pathway represents a highly promising target for disrupting cancer stem cell activity and inducing tumor differentiation. As we advance ipafricept and vantictumab through clinical studies in combination with standard of care, we expect to generate key data from these Phase 1b studies that will support a potential opt-in by our partner Bayer as well as late-stage clinical development."

OncoMed currently has five anti-cancer product candidates in clinical development, and is also developing antibodies and cancer immunotherapy products in collaboration with Bayer, GSK, and Celgene.

In July, Oncomed initiated the Phase 2 ALPINE clinical trials of its anti-Notch 2/3 cancer stem cell antibody, tarextumab (OMP-59R5), for the treatment of pancreatic cancer. Tarextumab is being tested in combination therapy in patients with previously untreated stage IV pancreatic cancer. In May, the FDA granted orphan drug designation to OncoMed's other cancer drug candidate, demcizumab (anti-DLL4, OMP-21M18), for the treatment of pancreatic cancer. OncoMed is currently conducting a Phase 1b clinical trial of demcizumab in first-line stage IV pancreatic cancer patients.