On Jan. 7, the companies announced a collaboration todevelop an in-vitro polymerase chainreaction (PCR)-based CDx test, with the goal of enabling the identification oflymphoma patients with non-wild type EZH2, including the Y641 mutation. The CDxwill be used to detect the EZH2 mutation in subjects to determine enrollmenteligibility for dosing with a compound that Epizyme and Eisai are developing.
"Roche is a company that possessed world-class cutting-edgetechnology and know-how, and has a proven history of companion diagnosticapprovals," says Lynn W. Kenney, senior director of corporate communicationsfor Eisai, of the company's decision to bring Roche into the fold.
Epizyme and Eisai announced their collaboration in March2011. That agreement gave Epizyme $6 million up front, with the potential toearn more than $200 million in additional research, development and salesmilestones, and up to double-digit royalties. Eisai agreed to fund 100 percentof the R&D costs through human proof-of-concept, at which point Epizyme hasthe right to opt into a profit-sharing and co-commercialization arrangement forthe United States.
In a September 2012 NatureChemical Biology paper, "A selective inhibitor of EZH2 blocks H3K27methylation and kills mutant lymphoma cells," Epizyme reported that lymphomaswith genetic alterations of EZH2 require EZH2 enzymatic activity forproliferation, and suggested that EZH2 is a driving oncogene in these cancersand therefore an important therapeutic target.
Ultimately, if the compound is successful in clinicalstudies and receives regulatory approval, the parties hope to make a companiondiagnostic available to help physicians identify patient candidates with theEZH2-related mutation who may be likely to benefit from the approved drug.
"Our collaboration with Epizyme and Eisai highlights Roche'sposition as the partner of choice for the development and commercialization ofcompanion diagnostics for personalized healthcare," said Paul Brown, head ofRoche Molecular Diagnostics, in a statement. "We are excited to be developing adiagnostic test that will support Epizyme and Eisai in the development of anEZH2 inhibitor as a new therapeutic for patients with genetically definedlymphomas."
The companies declined to comment on the commercialpotential of the test.