A partnership with a firm Foundation

CAMBRIDGE, Mass.—Foundation Medicine Inc. and ClovisOncology Inc. have announced the establishment of a diagnostics collaborationfor the development of an in-vitrodiagnostic to identify biomarkers for the selection of patients most likely torespond to Clovis' drug candidate rucaparib, a poly (ADP-ribose) polymerase(PARP) inhibitor. Financial details of the partnership were not disclosed.

"We are pleased to collaborate with Foundation Medicine,"Patrick J. Mahaffy, president and CEO of Clovis Oncology, said in a pressrelease. "This continues our commitment to developing targeted therapies withcompanion diagnostics to identify the patients most likely to benefit from ourtherapeutics. Foundation Medicine's leadership in next-generation sequencingand genomic analysis make them an ideal partner to work with us on ourrucaparib program."

The PARP inhibitor is currently in Phase I/II clinicaldevelopment, and under the collaboration, the partners will look for geneticmutations outside of the germ-line and somatic BRCA alterations that areassociated with the repair of defective DNA and which will hopefully providenew targets for rucaparib. For example, in high-grade serous ovarian cancer,the investigation could increase the percentage of patients eligible forrucaparib therapy from the 15 percent who typically present with germ-linemutations of BRCA to an estimated 40 to 50 percent who present with DNA repairdeficiencies as a result of somatic mutations in several genes.

Rucaparib is an orally available, small-molecular PARPinhibitor being developed to treat patients with cancers predisposed tosensitivity to PARP inhibitors. The drug candidate has been tested in both oraland intravenous forms, primarily paired with cytotoxic chemotherapy. Initial indicationsfor the drug include breast and ovarian cancers.

"We are absolutely committed to the development ofanti-cancer agents with companion diagnostics so that we can direct their usein patients much more likely to benefit from them based on the biology,"Mahaffy says. "This is emerging as a theme in oncology development. We're theonly company that is wholly focused on it, to our knowledge, but you do see,when they can … a desire and commitment on the part of Big Pharma to considerthis approach as well."

Mahaffy notes that the company has two other clinicalprograms also in development with companion diagnostics, one with Ventana andone with Roche Molecular. Clovis Oncology also has a discovery collaborationongoing, and if it proves successful in identifying an optimal compound,Mahaffy says it will be developed as well with a companion diagnostic partner.For the current collaboration, he notes that Foundation Medicine, given theirposition as a leader in next-generation sequencing and an interest indiagnostics, represents "absolutely the right partner."

"Foundation Medicine's core capability is the translation ofgenomic insights into clinically actionableinformation," Dr. Michael J. Pellini, president and CEO of FoundationMedicine, said in a press release. "But even the most in-depth genomic profilefor a patient is only as actionable as the available and relevant targetedtherapies. Therefore, we are working to help expand the universe of targetedtherapeutic options. Clovis Oncology, a recognized leader in patient-specificoncology drug development, is an ideal partner in this mission."

Mahaffy says he has high hopes for companion diagnostics andtheir ability to improve the treatment of cancer.

"To me, we're sort of in a golden age in biology where if wetake advantage of that, the improvements and outcomes for cancer patientsshould become meaningful over the next many years," says Mahaffy. "And many ofus understand how hard it is to imagine curing cancer, but with these types oftherapies, particularly when they can be sequenced depending on which mutationmay have emerged as most relevant at that time in that patient's cancer, wehope to make many of these forms of cancer much more like chronicallymanageable diseases than as the tragic sentence that they can often representtoday."

"The drive toward more personalized medicine is not limitedto oncology, and I think what's being learned in oncology over time will beapplied to other diseases as well," he concludes.