Inostics secured an exclusive, worldwide license from Johns Hopkins University to help the company develop DNA-based blood tests for mutations in the PIK3CA (phosphatidylinostitol 3-kinase catalytic subunit) cancer gene.
The Hamburg-based company says that it aims to use its BEAMing mutation detection platform to offer tests for detecting PIK3CA mutations in tissues as well as in plasma and serum. BEAMing is a sensitive digital technology that Inostics claims allows the detection and quantification of mutant DNA with an unpreceded sensitivity and selectivity.
Inostics suggests about a dozen or so pharma and biotech companies are already developing drugs that inhibit PIK3CA, which is one of the five most frequently mutated cancer genes. The company believes PIK3CA mutations may serve as predictive biomarkers for compounds targeting this pathway, and relevant mutation tests will have potential as companion diagnostics alongside PIK3CA inhibitor drugs. The company also believes that such tests could help with cancer screening and early detection.
The initial aim will be the development of tests for personalized cancer treatment. “We expect the first PIK3CA-based test to be launched within the next three years,” comments Hartmut Juhl, M.D., Ph.D., CEO and co-founder of Inostics and its parent company, Indivumed.
“A PIK3CA test will be an important tool to select patients for clinical trials of PIK3CA inhibitors, as mainly patients with a PIK3CA mutation are expected to benefit from such a treatment,” adds Frank Diehl, Ph.D., Inostics’ co-founder and CSO. “But it may also have a predictive value for patients’ response to drugs not specifically targeting PIK3CA, similar to the K-RAS testing that identified responders of EGFR-targeting compounds such as cetuximab.”