TAMPA, Fla.—CvergenX Inc., a Moffitt Cancer Center diagnosticsstartup company, and the National Cancer Institute (NCI) are collaborating ondeveloping a new test to determine which cancer patients will benefit fromradiation therapy—and which will not. If successful, this joint endeavor wouldresult in an accurate test that ultimately not only saves money on unnecessaryprocedures, but also saves lives.
To pave the way, CvergenX signed a partnership deal with theNCI's Clinical Assay Development Program (CADP) to harness a molecularsignature index technology called InterveneXRT, the company announced April 8.CvergenX created the gene-based diagnostic technology, which Moffitt owns andlicensed to CvergenX, in June 2010.
"Developing a radiosensitive predictive assay has been agoal of radiation biology for decades," Dr. Javier F. Torres-Roca, a member ofthe Chemical Biology and Molecular Medicine Program at Moffitt, and co-founderand chief scientific officer of CvergenX, stated in a news release. "Thiseffort supports the emphasis on personalized medicine, where the goal is to usemolecular signatures to guide therapeutic decisions."
Approximately 60 percent of all cancer patients receiveradiotherapy during their treatment, but until now, no molecular diagnostic orbiomarker for radiosensitivity has been developed to predict its benefit,Torres-Roca says. Through a series of clinical trials, Torres-Roca hasvalidated the molecular signature efficacy of InterveneXRT for patients withrectal, esophageal, head and neck and breast cancers. The NCI partnership will helpdevelop an assay that is ready for approval by the U.S. Food and DrugAdministration (FDA) for commercialization.
The radiosensitive molecular signature was originally developed based on geneexpression for 10 specific genes and a linear regression algorithm. It wasdeveloped in 48 cancer cell lines using a systems biology strategy focused onidentifying biomarkers for cellular radiosensitivity. The initial effortfocused on rectal cancer, where preoperative radiotherapy is part of thestandard of care for patients in stage 2 or 3 of the disease. However,approximately 40 percent of patients do not experience a clinical response topreoperative treatment. To date, the technology has been developed andcorrelated with retrospective clinical outcomes over more than seven years ofresearch and with the help of more than $2 million in funding, primarily fromthe NCI.
"CvergenX is one step closer to launching a game-changingprediction test for radiation therapy as a result of their exciting partnershipwith the NCI," says Jarett Rieger, director of the Office of TechnologyManagement and Commercialization.
The radiosensitive molecular signature was originally developed based on geneexpression for 10 specific genes and a linear regression algorithm. It wasdeveloped in 48 cancer cell lines using a systems biology strategy focused onidentifying biomarkers for cellular radiosensitivity. The initial effortfocused on rectal cancer, where preoperative radiotherapy is part of thestandard of care for patients in stage 2 or 3 of the disease. However,approximately 40 percent of patients do not experience a clinical response topreoperative treatment. To date, the technology has been developed andcorrelated with retrospective clinical outcomes over more than seven years ofresearch and with the help of more than $2 million in funding, primarily fromthe NCI.
Mary Del Brady, CvergenX's chairman and CEO, says theindividualization of radiation therapy is an important component ofpersonalized cancer treatment.
"We are the first commercial enterprise to develop acompanion diagnostic to radiation therapy, joining a growing group ofpersonalized medicine companies that are applying genomics-based analysis toclinical practice," Brady says. "Our goal is to have a validated test withproven clinical utility in the marketplace within the next three years. Thetest will provide more information, and far greater accuracy than oncologistsever had, enabling them to adjust their clinical management for better outcomesfor their patients."
Radiation therapy "has been shown to impact survival inmultiple cancers including breast, lung, prostate, head and neck and others,"she notes. "Therefore, it is possible that the more efficient utilization ofradiation therapy that will result from the clinical application of this testcould result in improved clinical outcomes at the survival level."
There are 1.5 million newly diagnosed cancer patients in theUnited States every year, "with more than 60 percent receiving radiation therapy,"Brady says.
"Worldwide, the market is huge, with more than 1.38 millioncases of breast cancer alone. While we do not assume that every patient willrequire the test, there is certainly a very large market both domestically andinternationally across most cancers," she concludes.
