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Roche, PhoenixMD Collaborating on CDx for Triple-Negative Breast Cancer Drug

NEW YORK (360Dx) – Phoenix Molecular Designs of Vancouver, Canada, said today that it is collaborating with Roche to develop a companion diagnostic for a kinase inhibitor developed for triple-negative breast cancer.

The assay, which primarily uses immunohistochemistry, according to PhoenixMD, identifies activation of the RSK2 kinase in tumors by measuring nuclear RSK2.

PhoenixMD has developed a small molecule inhibitor of RSK2, called PMD-026. Preliminary studies have shown that 80 percent of TNBC cases express activated RSK2 and that RSK2 is activated in 65 percent of tumors from a wide range of tumor types, according to the firm.

Over the next several months, Roche will establish a CAP/CLIA-certified protocol for the assay for clinical tumor analyses, and PhoenixMD will further refine its precision for identifying patients who may benefit from its RSK2 inhibitor in upcoming clinical trials.

PhoenixMD also plans to file an IND for the drug in the near future and to initiate a Phase I/Ib study in women with TNBC.

"By working together, PhoenixMD and Roche are at the forefront of innovation in TNBC, the most deadly breast cancer type with no approved therapies," said PhoenixMD CEO Sandra Dunn in a statement. "Creating our diagnostic assay and identifying disease biomarkers, such as RSK2 for TNBC, will dramatically reduce the development time needed to create targeted drugs and will improve a drug's chance of advancing through clinical trials. The top-line data generated from our CDx is encouraging, and we look forward to applying these learnings to identify TNBC patients that may benefit from PMD-026 in our upcoming Phase I/Ib study."