NCI, CvergenX to partner on radiosensitivity assay

TAMPA, Fla.—CvergenX, Inc. has announced an agreement withthe National Cancer Institute (NCI) to develop a new assay for radiationtherapy. CvergenX is developing a molecular signature index technology into aradiosensitivity test in conjunction with the NCI's Clinical Assay DevelopmentProgram. The technology, InterveneXRT, was selected by the NCI for furtherdevelopment and validation as part of a commercial collaboration agreement inhopes of getting the assay ready for clinical trials and U.S. Food and DrugAdministration approval.

CvergenX acquired the exclusive rights to the InterveneXRTtechnology platform in a previous licensing agreement with the Moffitt CancerCenter. No financial details were disclosed. Additional research collaborationsbetween the companies have demonstrated the product candidate's efficacy intrials for patients with breast, rectal, esophageal and head and neck cancers.

"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," Mary Del Brady, chairman and CEO of CvergenX, said in apress release. "Our goal is to have a validated test with proven clinicalutility in the marketplace within the next three years. The test will providemore information, and far greater accuracy, than oncologists have ever had,enabling them to adjust their clinical management for better outcomes for theirpatients."

The initial development of this molecular signature wasbased on gene expression for 10 specific genes as well as a linear regressionalgorithm. It was developed in 48 cancer cell lines using a systems-biologystrategy that focused on the identification of biomarkers for cellularradiosensitivity.

"Developing a radiosensitivity predictive assay has been agoal of radiation biology for decades," commented Javier F. Torres-Roca, M.D.,a member of the Radiation Oncology, Chemical Biology and Molecular MedicinePrograms at Moffitt and co-founder and chief scientific officer of CvergenX."This effort supports the emphasis on personalized medicine, where the goal isto use molecular signatures to guide therapeutic decisions."

Torres-Roca noted that approximately 60 percent of all cancerpatients receive radiotherapy at some point in their treatment, but so far nodiagnostics 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 adisease group in which preoperative radiotherapy is considered the standard ofcare for patients with Stage 2 or 3 cancer and yet roughly 40 percent ofpatients display no clinical response. The Clinical Assay Development Network,a nationwide network of CLIA-certified laboratories, placed a bid with the NCIfor this project and will perform the necessary work. Financing, labor andexpertise for the development of the assay will be provided by the NCI.

SOURCE: CvergenX press release