Pharmaceutical Business review

OncoMed starts Phase Ia trial of OMP-52M51 to treat solid tumors

The company said that advancement to the predictive biomarker expansion stage triggered a $5m milestone from its partner GlaxoSmithKline (GSK).

The expansion stage of the anti-Notch1 Phase Ia solid tumor trial is enrolling patients whose tumors show over expression of the activated form of Notch1.

In order to determine eligibility, patients’ tumors are pre-screened using the company’s immunohistochemistry (IHC) test.

The patients will receive anti-Notch1 at the recommended Phase II dose of 1.5mg/kg every three weeks.

At least ten biomarker-selected patients are expected to be enrolled in the expansion stage of the solid tumor Phase Ia trial.

OncoMed chief medical officer Jakob Dupont said: "The expansion stage aims to further characterize the safety profile of Anti-Notch1 at the Phase II single-agent dose while also exploring the activity of the drug candidate in patients with tumors demonstrating high levels of Notch1 activity.

"By utilizing a biomarker-selection strategy, we hope to identify those patients most likely to benefit from the treatment. We anticipate presenting data from this biomarker expansion cohort in 2015."

At present, anti-Notch1 is being evaluated in two Phase Ia clinical trials, one in patients with selected advanced solid tumors and the other in select hematologic malignancies.

Both the Phase Ia trials are designed to determine a maximum tolerated dose and to evaluate safety, pharmacokinetics, immunogenicity and preliminary efficacy.