Ipafricept is a first-in-class fusion protein that inhibits a key signaling pathway in cancer, the Wnt pathway.
The FDA removed the partial clinical hold, after the company submitted a substantial clinical safety and efficacy data package for ipafricept along with revised study protocols to its Division of Oncology Products.
Modified dosing regimens, risk mitigation measures, such as increased monitoring and bone protection strategies, and modified enrollment criteria are the amendments for the Phase Ib combination trials.
OncoMed chief medical officer Dr Jakob Dupont said: "With important input from our clinical investigators and academic bone experts, the OncoMed team has developed modified study parameters intended to avoid potential risks while allowing us to evaluate the therapeutic impact of ipafricept for patients with pancreatic, hepatocellular and ovarian cancers in combination with standard therapy."
Patient enrollment and dosing is expected to resume within the next few weeks as the trial sites’ institutional review boards (IRBs) receive and approve the revised trial protocols.
Currently, ipafricept is being evaluated tudied in combination with standard-of-care in three Phase Ib trials.
OncoMed chairman and chief executive officer Paul Hastings said the company expects that enrollment in its first-in-class Wnt pathway programs, ipafricept and vantictumab, to be back underway soon.
"The Wnt pathway represents a highly promising target for disrupting cancer stem cell activity and inducing tumor differentiation," Hastings said.