OncoMed ($OMED) is moving on from tandem setbacks in its cancer pipeline now that the FDA has removed its final clinical hold on one of the company's oncology candidates, clearing it to resume enrollment in a Phase I study.
In June, the company voluntarily halted dosing in three studies of ipafricept (Fzd8-Fc) when 5% of patients reported mild to moderate bone-related adverse events, and the FDA followed on with a requisite partial clinical hold that month. Now, after amending the studies' design, reducing dosage, altering safety monitoring and changing the patient enrollment criteria, the biotech has convinced the FDA to let it get back in business.
"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," Chief Medical Officer Jakob Dupont said in a statement.
The news comes a week after the agency gave OncoMed permission to resume Phase I work on vantictumab, an oncology candidate voluntarily halted at the same time as ipafricept over similar concerns.
OncoMed is working with Bayer on the two candidates, part of a 2010 deal in which the drug giant handed over $40 million up front for the right to opt in on up to 5 candidates that inhibit cancer stem cells' Wnt signaling pathway, agreeing to pay as much as $387.5 million for each. Vantictumab and ipafricept are the two most advanced candidates under the agreement.
The biotech's lead prospect is demcizumab, partnered with Celgene ($CELG) in a 2013 deal worth up to $3.3 billion that covers 5 more preclinical assets using the same cancer stem cell technology.
- read the statement
FDA lifts a hold on one of OncoMed's cancer drug programs
OncoMed hits the brakes on cancer studies after troubling safety signs
Celgene commits $3.3B in whopper cancer stem cell deal with OncoMed