OncoMed IND gains FDA approval to initiate Phase I clinical trials

OncoMed Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has accepted their Investigational New Drug filing for OMP18R5, a monoclonal antibody that binds selected receptors in the Wnt signaling pathway.

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REDWOOD CITY, Calif.—OncoMed Pharmaceuticals, Inc. has announcedthat the U.S. Food and Drug Administration (FDA) has accepted their InvestigationalNew Drug filing for OMP18R5, a monoclonal antibody that binds selectedreceptors in the Wnt signaling pathway. The company, which develops noveltherapeutics that target cancer stem cells or tumor-initiating cells, will bemoving the candidate into Phase I clinical testing.
"The acceptance from the FDA to begin clinical testing forOMP-18R5 represents an important milestone for OncoMed," says Paul Hastings,President and CEO of OncoMed. "OMP-18R5 is our first Wnt pathway programcleared to begin clinical trials, and we now have three novel agents in theclinic in multiple clinical trials."
OMP-18R5 is the first antibody that specifically blocksselectors in the Wnt pathway to enter human studies. The Wnt pathway controlsseveral biological processes by promoting cell-to-cell communication. Previousstudies have indicated that cancers in the skin, breast, liver and colon areassociated with abnormal signaling activity within the Wnt pathway. OncoMed'sstudy will be a single-agent study focused on evaluating the safety ofescalating doses of the compound in patients with advanced solid tumors, aswell as the pharmacokinetics, biomarkers and efficacy of the drug. Preclinicaltrials show that OMP-18R5 decreases the frequency of tumor-initiating cells ina 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 anddifferentiate, which can lead to tumor initiation as well as driving growth,recurrence and metastasis of tumors. OncoMed's scientific founders discoveredthese cells in breast cancer, and they have also been identified in other typesof solid tumor cancers, such as cancer of the head and neck, prostate,pancreas, lung and glioblastoma. The cells seem to be preferentially resistantto standard chemotherapy and radiotherapy.
OMP-18R5 is part of OncoMed's collaboration with BayerHealthCare Pharmaceuticals, and the advancement to clinical trials triggers a$20 million milestone payment from Bayer. The two companies entered into astrategic alliance June 2010 to develop cancer stem cell antibody and proteintherapeutics that target the Wnt signaling pathway, an alliance valued at up to$387.5 million per program. Per the arrangement, Bayer has the option oflicensing OncoMed's Wnt pathway biologics at any point through the completionof Phase I studies. The two companies are also working together towards thediscovering of small molecule Wnt signaling inhibitors.
"We are excited to continue building and advancing our richpipeline of first-in-class anti-cancer stem cell therapeutics with thepotential to dramatically transform cancer treatment by directly targetingtumor-initiating cells," says Hastings.

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