Despite the marked anti-tumor responses to Xalkori observed with ALK-driven tumors, most patients eventually experience disease progression as a consequence of resistance to the ALK inhibitor. In response to the issue of Xalkori resistance, a number of pharmaceutical and biotech companies currently have 2ndgeneration ALK small-molecule inhibitors in development. However, there are currently no diagnostic standards available for resistance testing. A robust companion diagnostic fulfilling this unmet clinical need will possess three main capabilities: 1) utility for clinical trial enrollment, 2) de novo mutation screening capability, and 3) reliable and efficient resistance mutation profiling over the entire disease course. During our Phase I development, the feasibility of Insight ALK Resistance was demonstrated as a panel of assays that will collectively identify all ALK inhibitor-resistance mutations reported in ALK-positive cancer patients resistant to Xalkori. The analytical design was proven in patient FFPE cancer specimens, indicating that the sensitivity was sufficient to provide a robust assay to profile heterogeneous tumor cell populations. Insight ALK Resistance is now ready to enter larger, pre-clinical trials to determine if the sensitivity and specificity can be recapitulated in clinically relevant FFPE specimens, and thus readied to proceed into final development for full FDA approval.

Agency
National Institute of Health (NIH)
Type
Small Business Innovation Research – Phase II (N44)
Project #
261201300087C-0-0-1
Application #
8742508
Study Section
Project Start
2013-09-20
Project End
2015-09-19
Budget Start
Budget End
Support Year
Fiscal Year
2013
Total Cost
$1,499,990
Indirect Cost
Name
Insight Genetics, Inc.
Department
Type
DUNS #
190114962
City
Nashville
State
TN
Country
United States
Zip Code
37203