REDWOOD CITY, Calif.—Genomic Health Inc. and OncoMedPharmaceuticals Inc. have formed a strategic alliance that will usenext-generation sequencing (NGS) to identify biomarkers that can be applied tothe clinical development of OncoMed's novel antibody cancer therapeutics.
"Working with like-minded, innovative cancer companies, wecan utilize our proven next-generation sequencing-based diagnostic research anddevelopment infrastructure to help optimize patient selection to accelerateclinical development of targeted cancer treatments," says Dr. Steven Shak,Genomic Health's chief medical officer. "This collaboration supports ourlong-term vision and belief that molecular diagnostics are inherent forbringing quality, personalized care to all cancer patients from diagnosisthrough survivorship."
Under the terms of the agreement, OncoMed will provideGenomic Health with breast, prostate, colon and lung tumor samples. A subset ofthese tumors will include OncoMed's extensive bank of proprietary xenograftmodels derived from freshly resected human cancers. Genomic Health will applyits NGS capabilities, including proprietary sample preparation, high-throughputsequencing and bioinformatics, to discover biomarkers that can help identifysubsets of patients that will more likely respond to cancer therapeuticstargeting the Notch, Wnt and other pathways critical to cancer stem cells.
Shak points out that the company has made major strides inthe utilization of NGS technology to assay the entire genome simultaneously todiscover regions where expression is associated with clinical outcomes andtreatment response. In 2011, the company announced its decision to acceleratethe program into clinical development studies examining both RNA-Seq geneexpression and mutation analysis. This decision followed the successfulcompletion of the clinical outcomes study for biomarker discovery using NGS forwhole transcriptome profiling of fixed tumor specimens.
"Our priority is not only to develop therapeutic antibodiesbut to target their clinical use in the subsets of patients most likely tobenefit through focused clinical plans, which include patient selectionstrategies at early stages of testing," says Paul J. Hastings, president andCEO of OncoMed. "We believe the collaboration with Genomic Health willaccelerate our already existing efforts of developing predictive biomarkersalongside the development of our anti-cancer stem cell therapeutics."
Genomic Health's lead product, the Oncotype DX breast cancertest, has been shown to predict the likelihood of chemotherapy benefit as wellas recurrence in invasive breast cancer and to predict the likelihood ofrecurrence in ductal carcinoma in situ.A genomic test, such as Oncotype DX, looks at groups of genes and how activethey are. This activity can influence how a cancer is likely to grow andrespond to treatment.
Unlike a breast cancer genetic test, the Oncotype DXbreast cancer test does not provide information about a person's inheritedgenetic make-up. Instead, it looks at genes in a patient's breast tumor tounderstand how these genes interact and influence the tumor's behavior. Basedon the multi-gene analyses of the tumor sample, Oncotype DX assigns the breastcancer a Recurrence Score. This score is a number between 0 and 100 thatcorresponds to a specific likelihood of experiencing breast cancer recurrencewithin 10 years of initial diagnosis. The lower your score, the less likely thecancer is to recur, in which case chemotherapy treatment is likely to be oflittle if any benefit. The higher the score, the more likely the cancer is torecur, in which case chemotherapy may be beneficial in reducing this risk ofrecurrence.
In addition to this widely adopted test, Genomic Healthprovides the Oncotype DX colon cancer test, the first multigene expression testdeveloped for the assessment of risk of recurrence in patients with stage IIdisease. As of March 31, more than 10,000 physicians in more than 65 countrieshad ordered upwards of 275,000 Oncotype DX tests.
Privately held OncoMed Pharmaceuticals is a clinical-stagecompany that discovers and develops novel therapeutics targeting cancer stemcells, the cells believed to be capable of driving tumor growth, recurrence andmetastasis. The company has established a library of antibodies to cancer stemcell proteins for the treatment of solid tumors such as pancreatic, breast, colorectaland lung cancers.