OncoMed IND gains FDA approval to initiate Phase I clinical trials
REDWOOD CITY, Calif.—OncoMed Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted their Investigational New Drug filing for OMP18R5, a monoclonal antibody that binds selected receptors in the Wnt signaling pathway. The company, which develops novel therapeutics that target cancer stem cells or tumor-initiating cells, will be moving the candidate into Phase I clinical testing.
"The acceptance from the FDA to begin clinical testing for OMP-18R5 represents an important milestone for OncoMed," says Paul Hastings, President and CEO of 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."
OMP-18R5 is the first antibody that specifically blocks selectors in the Wnt pathway to enter human studies. The Wnt pathway controls several biological processes by promoting cell-to-cell communication. Previous studies have indicated that cancers in the skin, breast, liver and colon are associated with abnormal signaling activity within the Wnt pathway. OncoMed's study will be a single-agent study focused on evaluating the safety of escalating doses of the compound in patients with advanced solid tumors, as well as the pharmacokinetics, biomarkers and efficacy of the drug. Preclinical trials show that OMP-18R5 decreases the frequency of tumor-initiating cells in a variety of different tumor types.
Cancer stem cells, also known as "tumor-initiating cells," are a small subset of cells found in tumors with the capacity to self-renew and differentiate, which can lead to tumor initiation as well as driving growth, recurrence and metastasis of tumors. OncoMed's scientific founders discovered these cells in breast cancer, and they have also been identified in other types of solid tumor cancers, such as cancer of the head and neck, prostate, pancreas, lung and glioblastoma. The cells seem to be preferentially resistant to standard chemotherapy and radiotherapy.
OMP-18R5 is part of OncoMed's collaboration with Bayer HealthCare Pharmaceuticals, and the advancement to clinical trials triggers a $20 million milestone payment from Bayer. The two companies entered into a strategic alliance June 2010 to develop cancer stem cell antibody and protein therapeutics that target the Wnt signaling pathway, an alliance valued at up to $387.5 million per program. Per the arrangement, Bayer has the option of licensing OncoMed's Wnt pathway biologics at any point through the completion of Phase I studies. The two companies are also working together towards the discovering of small molecule Wnt signaling inhibitors.
"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," says Hastings.