Foundation Medicine ($FMI) will develop a companion diagnostic test for use with a Clovis Oncology ($CLVS) drug now in mid-stage clinical trials to treat patients with ovarian cancer.
The deal builds on an ongoing collaboration between Foundation Medicine, a Cambridge, MA, diagnostics darling, and Clovis, a Boulder, CO-based drug developer. It also follows Foundation's announcement in late March of plans to raise as much as $150 million in a secondary offering to fuel domestic and international expansion as well as new product development.
Foundation, as part of the deal, will work with Clovis to develop a coordinated strategy for a new companion diagnostic that would obtain premarket approval. Physicians would use it to spot patients most likely to respond to Clovis' drug rucaparib, a PARP inhibitor currently in Phase II and III clinical trials to treat ovarian cancer patients. The idea is to pursue concurrent development of both the diagnostic test and the drug, so Foundation submits for PMA approval around the same time Clovis files its new drug application for rucaparib. Work is already well underway, the companies said, with Foundation's broader diagnostic platform in use in Clovis' ARIEL2 clinical trial of the drug. A final companion diagnostic will be based on that technology, the companies said.
"This collaboration markets a paradigm shift in the development of companion diagnostics," Foundation Medicine President and CEO Dr. Michael Pellini said in a statement. "The use of Foundation Medicine's platform is an important step in the evolution of cancer from a static, single-gene companion diagnostic approach toward a universal companion diagnostic standards."
Pellini added that the deal "complements Foundation Medicine's plans to develop an FDA-approved companion diagnostic and supports our overall strategy to work with the FDA to establish the appropriate regulatory framework for novel, genomic profiling platforms."
Foundation Medicine's core technology is known as FoundationOne, a sequencing-based diagnostic test designed to run through 236 cancer-related genes to match patients with the best possible treatment. In December, the company launched FoundationOne Heme, a test for various blood-based cancers that uses the same core technology. Foundation Medicine, a 2012 FierceBiotech Fierce 15 company, recently announced plans for a secondary offering of up to $150 million, after raising a net of $111 million in an IPO last fall.
The company, which launched in 2009, is also working with collaborators including Johnson & Johnson ($JNJ), Novartis ($NVS), and Sanofi ($SNY), among others.
- read the release
Special Report: FierceBiotech's 2012 Fierce 15 - Foundation Medicine