Inostics acquires from Johns Hopkins University an exclusive license for detection of PIK3CA

Subsidiary of Indivumed aims to develop DNA-based blood tests for individualizing cancer therapy

16-Nov-2009 - Germany

Inostics GmbH announced it has obtained a world-wide exclusive license for detection of PIK3CA mutations from Johns Hopkins University (Baltimore, MD). The license grants Inostics, a subsidiary of Indivumed, the exclusive right to use digital PCR techniques and other technologies such as sequencing to determine PIK3CA mutations. Based on its proprietary BEAMing technology, a highlysensitive, digital technology, allowing for the detection and quantification of mutant DNA with an unprecedented sensitivity and selectivity, Inostics will be the sole provider to offer tests for the detection of PIK3CA mutations not only in tissues but also in plasma and serum.

A few years ago, Bert Vogelstein, one of the co-founders of Inostics, discovered that
mutations in the PIK3CA gene may play an important role in tumor cell proliferation as well as in invasion and metastasis. Thereby, PIK3CA mutations may also serve as predictive biomarker for compounds targeting the PIK3CA pathway. PIK3CA mutations have already been found in several common cancer types, such as breast and colon cancer. Meanwhile, it has been demonstrated that PIK3CA belongs to the five most frequently mutated cancer genes.

While about a dozen pharma and biotech companies currently are developing drugs to inhibit PIK3CA, Inostics aims to develop plasma and tissue tests for the detection of PIK3CA mutations.

„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,“ said Frank Diehl, CSO and cofounder of Inostics. „In addition, such a test may be used for companion diagnostics, i.e. to stratify patients once a PIK3CA inhibitor is approved, similar to HER2/neu testing in patients receiving anti-cancer antibodies such as trastuzumab. But it may also have a predictive value for patients' response to drugs not specifically targeting PIK3CA, similar to the K-RAS testing that identifies responders of EGFR targeting compounds such as cetuximab.“

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