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Trials & Filings

OncoMed Hits Dose Escalation Milestone

Triggers $15 mil. payment from Bayer

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

OncoMed Pharmaceuticals has earned a $15 million milestone payment from Bayer Pharma AG related to achieving a dose escalation milestone in the Phase Ia clinical trial of OMP-54F28 (Fzd8-Fc). OMP-54F28 is an antagonist of the Wnt pathway, a key cancer stem cell pathway.

The Phase Ia trial of OMP-54F28 is an open-label dose escalation study in patients with advanced solid tumors. It is designed to assess OMP-54F28 for safety, immunogenicity, pharmacokinetics, biomarkers, and initial signals of efficacy. In the ongoing study, OMP-54F28 has been well tolerated at doses up to 15 mg/kg every three weeks, which is above the target efficacious dose based on OncoMed’s preclinical studies in minimally passaged human tumor xenograft models.

OMP-54F28 is one of five anti-CSC product candidates currently being advanced through clinical studies by OncoMed and the company’s second distinct Wnt-pathway modulating therapeutic to enter the clinic as part of the collaboration between OncoMed and Bayer. OncoMed’s first Wnt pathway anti-cancer stem cell compound, vantictumab (OMP-18R5, Anti-FZD7), is being advanced into three Phase Ib combination clinical studies. The first of these trials was recently initiated in patients with advanced breast cancer to evaluate the combination of vantictumab with paclitaxel. Bayer retains an option to exclusively license OMP-54F28 and/or vantictumab at any point through completion of certain Phase I trials.

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