US-based OncoMed Pharmaceuticals has enrolled first biomarker-selected patient in its Phase Ia solid tumour clinical trial of an anti-Notch1 antibody (OMP-52M51) to treat solid tumours.
Advancement to the predictive biomarker expansion stage triggered a $5m milestone from the company’s partner GlaxoSmithKline (GSK).
The expansion stage of the anti-Notch1 Phase Ia solid tumour trial is enrolling patients whose tumours show over expression of the activated form of Notch1.
The company said that patients tumours are pre-screened using its immunohistochemistry (IHC) test to determine eligibility.
They will receive anti-Notch1 at the recommended Phase II dose of 1.5mg/kg every three weeks.
The expansion stage of the solid tumour Phase Ia trial is expected to enrol at least ten biomarker-selected patients.
OncoMed chief medical officer Jakob Dupont said: "The expansion stage aims to further characterise 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 tumours demonstrating high levels of Notch1 activity.
"By utilising 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."
Currently, anti-Notch1 is being evaluated in two Phase Ia clinical trials, one in patients with selected advanced solid tumours and the other in select haematologic malignancies.
The solid tumour types included in the trial are HER2-negative breast, esophageal, colorectal, gastric, pancreatic, small cell lung, adenoid cystic carcinoma and cholangiocarcinoma,
According to the company, all tumour types where over expression of the activated form of Notch1 occurs in at least 10% of patients.
Both the Phase Ia trials are designed to determine a maximum tolerated dose and to assess safety, pharmacokinetics, immunogenicity and preliminary efficacy.
OncoMed chairman and chief executive officer Paul Hastings said: "The initiation of the biomarker-selected expansion stage of the anti-Notch1 Phase Ia clinical trial triggers our latest milestone payment of $5m from our partner, GSK. The expansion cohort also moves this program one step closer to a potential opt-in."
In December 2007, OncoMed and GSK entered into a strategic alliance to develop cancer stem cell antibody therapeutics targeting the Notch signalling pathway.
