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A partnership with a firm Foundation
CAMBRIDGE, Mass.—Foundation Medicine Inc. and Clovis Oncology Inc. have announced the establishment of a diagnostics collaboration for the development of an in-vitro diagnostic to identify biomarkers for the selection of patients most likely to respond 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 press release. "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."
The PARP inhibitor is currently in Phase I/II clinical development, and under the collaboration, the partners will look for genetic mutations outside of the germ-line and somatic BRCA alterations that are associated with the repair of defective DNA and which will hopefully provide new targets for rucaparib. For example, in high-grade serous ovarian cancer, the investigation could increase the percentage of patients eligible for rucaparib therapy from the 15 percent who typically present with germ-line mutations of BRCA to an estimated 40 to 50 percent who present with DNA repair deficiencies as a result of somatic mutations in several genes.
Rucaparib is an orally available, small-molecular PARP inhibitor being developed to treat patients with cancers predisposed to sensitivity to PARP inhibitors. The drug candidate has been tested in both oral and intravenous forms, primarily paired with cytotoxic chemotherapy. Initial indications for the drug include breast and ovarian cancers.
"We are absolutely committed to the development of anti-cancer agents with companion diagnostics so that we can direct their use in 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 the only 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 consider this approach as well."
Mahaffy notes that the company has two other clinical programs also in development with companion diagnostics, one with Ventana and one with Roche Molecular. Clovis Oncology also has a discovery collaboration ongoing, 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 their position as a leader in next-generation sequencing and an interest in diagnostics, represents "absolutely the right partner."
"Foundation Medicine's core capability is the translation of genomic insights into clinically actionable information," Dr. Michael J. Pellini, president and CEO of Foundation Medicine, said in a press release. "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."
Mahaffy says he has high hopes for companion diagnostics and their ability to improve the treatment of cancer.
"To me, we're sort of in a golden age in biology where if we take advantage of that, the improvements and outcomes for cancer patients should become meaningful over the next many years," says Mahaffy. "And many of us understand how hard it is to imagine curing cancer, but with these types of therapies, particularly when they can be sequenced depending on which mutation may have emerged as most relevant at that time in that patient's cancer, we hope to make many of these forms of cancer much more like chronically manageable diseases than as the tragic sentence that they can often represent today."
"The drive toward more personalized medicine is not limited to oncology, and I think what's being learned in oncology over time will be applied to other diseases as well," he concludes.