Foundation Medicine, Inc. and Clovis Oncology, Inc. (Nasdaq:CLVS) announced today that they have entered into a diagnostic collaboration. The goal of the collaboration is to develop an in-vitro diagnostic (IVD) to identify biomarkers to select cancer patients most likely to respond to Clovis’ product candidate rucaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor currently in Phase I/II clinical development.
“We are pleased to collaborate with Foundation Medicine,” said Patrick J. Mahaffy, president and CEO of Clovis Oncology. “This continues our commitment to developing targeted therapies with companion diagnostics to identify the patients most likely to benefit from our therapeutics. Foundation Medicine’s leadership in next generation sequencing and genomic analysis make them an ideal partner to work with us on our rucaparib program.”
Foundation Medicine and Clovis Oncology will analyze the genomic alterations found in tissue samples from patients to evaluate the feasibility of developing an IVD method to identify patients who have tumors more likely to respond to rucaparib.
In particular, the goal of the collaboration is to identify the additional genetic mutations beyond those in germ-line and somatic BRCA that are associated with defective DNA repair and may define appropriate tumor targets for rucaparib. In high-grade serous ovarian cancer, for example, this study has the potential to increase the percentage of ovarian cancer patients potentially eligible for rucaparib therapy from the 15 percent typically found to have germ-line mutations of BRCA to an estimated 40 to 50 percent who have DNA repair deficiencies caused by somatic mutations in a variety of genes.
“Foundation Medicine’s core capability is the translation of genomic insights into clinically actionable information,” said Michael J. Pellini, M.D., president and CEO of Foundation Medicine. “But even the most in-depth genomic profile for a patient is only as actionable as the available and relevant targeted therapies. Therefore, we are working to help expand the universe of targeted therapeutic options. Clovis Oncology, a recognized leader in patient-specific oncology drug development, is an ideal partner in this mission.”