FDA lifts partial clinical hold for OncoMed’s vantictumab trials

US biotech firm OncoMed Pharmaceuticals (Nasdaq: OMED) saw its shares leap 9.9% to $21.58 on Thursday on news that the US Food and Drug Admi9nistration has removed the partial clinical hold on enrollment in the company's vantictumab (anti-Fzd7, OMP-18R5) Phase I clinical trials.

Vantictumab is being studied in combination with standard-of-care 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. Enrollment and dosing of new patients is expected to resume within the next few weeks as the study sites' institutional review boards (IRBs) receive and approve the revised trial protocols.

"We are pleased by the FDA's action to allow the resumption of enrollment in the vantictumab clinical trials," said Jakob Dupont, OncoMed's chief medical officer. "Patient safety is our top priority. 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," Dr Dupont added.