Genomic Health and OncoMed established a strategic partnership focused on the use of next-generation sequencing (NGS) to identify biomarkers that will aid clinical development of the latter’s antibody cancer therapeutics. OncoMed will provide Genomic Health with breast, prostate, colon, and lung tumor samples including xenograft models derived from freshly resected human cancers.
Genomic Health will then use its NGS platform and technologies to find biomarkers that can help identify patients most likely to respond to cancer therapeutics targeting pathways such as Notch andWnt that are critical to cancer stem cells.
OncoMed says the collaboration will accelerate its drive to develop predictive biomarkers enabling the stratification of patients from the early clinical stages of development. “This collaboration supports our long-term vision and belief that molecular diagnostics are inherent for bringing quality, personalized care to all cancer patients from diagnosis through survivorship,” says Steven Shak, M.D., Genomic Health’s CMO. “We can utilize our proven NGS-based diagnostic research and development infrastructure to help optimize patient selection to accelerate clinical development of targeted cancer treatments.”
OncoMed is exploiting its expertise in the field of cancer stem cells to develop antibody-based drugs that target biological pathways critical to the survival of these tumor-initiating cells. The OncoMed pipeline includes antibody candidates targeting the Notch and Wnt pathways, and a dual DLL4/VEGF-targeting antibody. OMP-21M18, a mAb that targets the Notch activating delta-like ligand 4 (DLL4), is a lead candidate.
The firm says DLL4 blockade results in broad-spectrum antitumor activity including angiogenesis disruption and cancer stem cell growth inhibition. Phase I studies evaluating the antibody in combination with standard chemotherapy are ongoing in patients with advanced non-small-cell lung cancer and pancreatic cancer. A Phase I monotherapy trial with DLL4 in heavily pretreated solid tumor patients demonstrated evidence of single agent activity.
Phase I studies with the anti-Notch2/3 candidate OMP-59R5 and the frizzled receptor Wnt pathway inhibitor OMP-18R5, were initiated in 2011. IND filings for a Notch1 antibody candidate and a second Wnt pathway inhibitor are projected in 2012. OncoMed is developing the Wnt pathway inhibitor programs as part of a strategic collaboration with Bayer HealthCare signed in 2010. Also in 2010 the firm was awarded $1.2 million under the U.S. government’s Qualifying Therapeutic Discovery Project program to support the development of five distinct therapeutic programs.
Genomic Health is a molecular diagnostics company focused on the development and commercialization of tumor profiling molecular diagnostics that can predict individual patient responses to specific anticancer therapies and indicate the likelihood of disease recurrence. The firm’s flagship Oncotype DX breast and colon cancer assays are commercially available to help individualize cancer treatment options and predict recurrence. Genomic Health’s pipeline includes diagnostic assays for tumor types including prostate, non-small-cell lung, kidney, and melanoma.