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NCI, CvergenX to partner on radiosensitivity assay
TAMPA, Fla.—CvergenX, Inc. has announced an agreement with the National Cancer Institute (NCI) to develop a new assay for radiation therapy. CvergenX is developing a molecular signature index technology into a radiosensitivity test in conjunction with the NCI's Clinical Assay Development Program. The technology, InterveneXRT, was selected by the NCI for further development and validation as part of a commercial collaboration agreement in hopes of getting the assay ready for clinical trials and U.S. Food and Drug Administration approval.
CvergenX acquired the exclusive rights to the InterveneXRT technology platform in a previous licensing agreement with the Moffitt Cancer Center. No financial details were disclosed. Additional research collaborations between the companies have demonstrated the product candidate's efficacy in trials for patients with breast, rectal, esophageal and head and neck cancers.
"We are the first commercial enterprise to develop a companion diagnostic to radiation therapy, joining a growing group of personalized medicine companies that are applying genomics-based analysis to clinical practice," Mary Del Brady, chairman and CEO of CvergenX, said in a press release. "Our goal is to have a validated test with proven clinical utility in the marketplace within the next three years. The test will provide more information, and far greater accuracy, than oncologists have ever had, enabling them to adjust their clinical management for better outcomes for their patients."
The initial development of this molecular signature was based on gene expression for 10 specific genes as well as a linear regression algorithm. It was developed in 48 cancer cell lines using a systems-biology strategy that focused on the identification of biomarkers for cellular radiosensitivity.
"Developing a radiosensitivity predictive assay has been a goal of radiation biology for decades," commented Javier F. Torres-Roca, M.D., a member of the Radiation Oncology, Chemical Biology and Molecular Medicine Programs at Moffitt and co-founder and chief scientific officer of CvergenX. "This effort supports the emphasis on personalized medicine, where the goal is to use molecular signatures to guide therapeutic decisions."
Torres-Roca noted that approximately 60 percent of all cancer patients receive radiotherapy at some point in their treatment, but so far no diagnostics or biomarkers have been developed to help weigh radiosensitivity, the state of the cancer and possible benefits.
Rectal cancer will be the initial focus, as it represents a disease group in which preoperative radiotherapy is considered the standard of care for patients with Stage 2 or 3 cancer and yet roughly 40 percent of patients display no clinical response. The Clinical Assay Development Network, a nationwide network of CLIA-certified laboratories, placed a bid with the NCI for this project and will perform the necessary work. Financing, labor and expertise for the development of the assay will be provided by the NCI.
SOURCE: CvergenX press release