One of the hottest topics in drug development these days is developing a companion diagnostic for an experimental drug. While that's no easy task, the upstart Clovis Oncology announced that it has teamed with Roche to do just that for one of its preclinical covalent drug programs.
The goal of this new pact is to develop a diagnostic test for EGFR mutations found in non-small cell lung cancer, including the EGFR T790M mutation. Roche officials touted the pact as a clear indication of its market-leading rep in the field of companion diagnostics. Clovis CEO Patrick Mahaffy underscored the biotech's commitment to identifying genetically defined patient groups which will respond to new drugs.
"By incorporating a companion diagnostic during clinical and commercial development of CO-1686, we reinforce our commitment to focus development programs on specific subsets of cancer populations that are most likely to benefit from our targeted therapies," says the CEO, a well known veteran in the cancer field.
Mahaffy and a team of executives came out of Pharmion, which Celgene acquired for close to $3 billion. Armed with some deep-pocket venture backers and a huge $145 million Series A in 2009, the biotech upstart patiently set out to license in new programs and build a "tumor agnostic" cancer drug company.
CO-1686 was licensed in from Avila. The treatment is designed to target and covalently bind to the activating and T790M mutant forms of EGFR. And Clovis points out that "it does so while also sparing wild-type (normal) EGFR and may thus treat refractory NSCLC while minimizing dose-limiting side effects."
- here's the Clovis/Roche release
Special Report: Clovis Oncology - 2009 Fierce 15