OncoMed Pharmaceuticals, Inc., a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today announced that patient dosing has begun in a Phase I clinical trial of OMP-54F28 in patients with advanced solid tumor cancers. OMP-54F28 is OncoMed's fourth drug to enter clinical development. OMP-54F28 is a proprietary fusion protein based on a truncated form of the Frizzled8 receptor, or Fzd8, and is the company's second Wnt pathway modulator to enter the clinic as part of the collaboration between OncoMed and Bayer HealthCare Pharmaceuticals. OncoMed's first Wnt pathway targeting drug in the clinic is OMP-18R5, a monoclonal antibody targeting the Frizzled receptors. OMP-18R5 continues to advance in the clinic.
“In less than two years, we have successfully created a strong body of preclinical data for two distinct approaches and thereby expanded our clinical pipeline of potential first-in-class anti-cancer stem cell therapeutics.”
The Phase I clinical trial of OMP-54F28 is an open-label dose escalation study in patients with advanced solid tumors for which there is no remaining standard curative therapy. These patients are assessed for safety, immunogenicity, pharmacokinetics, biomarkers, and initial signals of efficacy.
The trial is being conducted at Pinnacle Oncology Hematology in Scottsdale, Arizona, the University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, and the University of Colorado Cancer Center under the direction of Principal Investigators Dr. Michael S. Gordon, Dr. David Smith and Dr. Antonio Jimeno, respectively. According to Dr. Gordon, who treated the first patient with OMP-54F28, "It is exciting to bring novel agents such as OMP-54F28 that target key cancer pathways such as Wnt into the clinic. We believe that this investigational therapy has great potential based on its preclinical evidence of anti-tumor activity."
OncoMed believes that OMP-54F28 is a potent antagonist of the Wnt pathway, a key cancer stem cell pathway. OMP-54F28 has shown evidence of anti-tumor activity and reduction of CSC frequency in multiple preclinical models either as a single agent or when combined with chemotherapy. OncoMed has worked collaboratively with Bayer's US affiliate Bayer HealthCare, LLC to manufacture the clinical supply of OMP-54F28 for this program. Bayer Pharma AG retains an option to exclusively license OMP-54F28 at any point through completion of certain Phase I trials.
"The advancement of a second clinical molecule targeting the Wnt pathway is an important milestone for us and our collaboration with Bayer," said Paul Hastings, President and Chief Executive Officer of OncoMed Pharmaceuticals. "In less than two years, we have successfully created a strong body of preclinical data for two distinct approaches and thereby expanded our clinical pipeline of potential first-in-class anti-cancer stem cell therapeutics."
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