OvaGene Oncology negotiated license agreements with two Norwegian research organizations for biomarker-related IP that it aims to develop into clinical laboratory tests for identifying high-risk endometrial cancer patients and predicting chemoradiation resistance in cervical cancer. The firm says that it is working to validate the tests and will offer them through its newly established OvaGene CLIA lab during the next 12–18 months.
The IP licensed from the University of Bergen Technology Transfer Office is a set of markers that OvaGene believes can indicate which early-stage endometrial cancer patients may require chemotherapy in addition to surgery. The biomarkers licensed from the Oslo-based technology transfer organization Medinnova will allow cervical cancer patients to be tested for chemoradiation resistance before treatments are started, OvaGene states.
Endometrial cancer patients are currently assessed using pathological features. These, however, do not always accurately identify women who may need additional adjuvant therapy, OvaGene points out. “Hopefully these molecular markers will allow us to better define who should be offered additional therapy,” remarks OvaGene CMO, Neil Finkler, M.D. Dr. Finkler suggests the licensed panel of markers may also provide new insights into the role of PI3K inhibitor drugs.
OvaGene believes the cervical cancer assay will help clinicians decide whether a patient will respond to platinum-based treatments used as standard in combination with radiation therapy against stage IB2 to IV disease. “Knowing which cervical cancer patients will not respond to this standard treatment before starting therapy would allow the clinician the opportunity to offer alternative drug therapy up front rather than at time of recurrence,” states Bill Ricketts, Ph.D., CSO.
OvaGene specializes in the development and commercialization of personalized DNA-based diagnostics for gynecologic cancers. The newly licensed IP is integral to the firm’s drive to develop proprietary molecular diagnostic and prognostic assays for gynecologic cancers and therapy selection. Two proprietary tests, OvaGene and EndoGene, are already in development in house.
OvaGene is designed to evaluate the expression of 44 specific genes in pathways related to drug response and clinical outcome in ovarian cancer. The firm says that the test will initially be offered using the current supporting medical literature for each gene. It has in addition developed a phased clinical plan to further validate the genes for use in ovarian cancer treatment and determine its predictive value, clinical utility, and cost effectiveness.
EndoGene evaluates expression biomarkers in endometrial cancer specimens. The assay will initially consist of 27 genes supported by references correlating the genes with disease outcome. OvaGene aims to carry out further studies to validate the correlation of both disease outcome-related genes and drug response-related genes for detecting early-stage, high-risk endometrial cancers.
Toward the end of June OvaGene opened its new clinical and research laboratory in Irvine, CA. The facility will serve as the firm’s central headquarters for operations, research, and molecular clinical lab testing. At the time OvaGene confirmed it was pursuing CLIA and CAP clearance.