FDA accepts OncoMed's IND filing for OMP-18R5 in Phase 1 clinical trial for advanced solid tumors

OncoMed Pharmaceuticals, Inc., a company developing novel therapeutics that target cancer stem cells or tumor-initiating cells, today announced that the FDA has accepted an IND filing for OMP-18R5, which allows OncoMed to commence Phase 1 clinical testing.  

OMP-18R5 is a monoclonal antibody that binds selected receptors in the Wnt signaling pathway and is the first antibody to specifically block these targets to enter human studies.  The Phase 1 clinical trial of OMP-18R5 is a single-agent study designed to evaluate the safety of escalating doses of OMP-18R5 in patients with advanced solid tumors.  The study will also assess pharmacokinetics, biomarkers and initial evidence of efficacy.  The Phase 1 trial is being conducted at leading U.S. cancer drug development centers.  Preclinical studies have shown that OMP-18R5 decreases the frequency of tumor-initiating cells across a variety of tumor types.  

"The acceptance from the FDA to begin clinical testing for OMP-18R5 represents an important milestone for OncoMed.  OMP-18R5 is our first Wnt pathway program cleared to begin clinical trials, and we now have three novel agents in the clinic in multiple clinical trials," said Paul Hastings, President and Chief Executive Officer of OncoMed Pharmaceuticals.  "We are excited to continue building and advancing our rich pipeline of first-in-class anti-cancer stem cell therapeutics with the potential to dramatically transform cancer treatment by directly targeting tumor-initiating cells."  

OMP-18R5 is part of OncoMed's collaboration with Bayer HealthCare Pharmaceuticals and its advancement to the clinic triggers a $20M milestone payment from Bayer to OncoMed.  In June 2010, OncoMed and Bayer entered into a broad strategic alliance valued at up to $387.5M per program to develop cancer stem cell antibody and protein therapeutics targeting the Wnt signaling pathway.  Bayer has the option to license OncoMed's biologics in the Wnt pathway at any point through the completion of Phase 1 studies.  In addition, Bayer and OncoMed are working together to discover small molecule Wnt signaling inhibitors as part of the collaboration.