Subsidiary of Indivumed aims to develop DNA-based blood tests for individualizing cancer therapy
Hamburg and Washington (DC), November 13, 2009 – Inostics GmbH, a molecular diagnostics company providing molecular tools and services to support individualized cancer patient management and drug development, today 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 highly-sensitive, 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.”
According to Hartmut Juhl, CEO and co-founder of Indivumed as well as Inostics, a PIK3CA test might also become an important element in future tests for screening and early cancer detection. “However, at present we focus on the development of tests for a personalized cancer treatment,” he said. “Inostics will contribute DNA markers, while Indivumed will develop protein markers. We assume that intelligent combination of both approaches will significantly improve patient care in the future. We expect a first PIK3CA-based test to be launched within the next 3 years.”
About BEAMing Technology
Inostics´ proprietary BEAMing Technology (beads, emulsions, amplification and magnetics) is the core of the company‘s technology platform for the rapid and highly sensitive detection and quantification of low abundant mutant tumor DNA molecules in biological samples. The technology performs amplification of individual DNA fragments covalently linked to magnetic beads. As the beads are suspended in water-based nanoparticles immersed in oil droplets, the amplification needs only minute amounts of reagents and can be carried out in a highly paralleled fashion.
As an example, it is possible to identify more than one mutated DNA fragment among 10,000 non-mutated (normal) fragments. The sensitivity is significantly higher compared to conventional PCR techniques and enables not only detection but also quantification of tumor related DNA molecules in blood samples such as plasma or serum.
In September 2008 INDIVUMED founded the subsidiary INOSTICS GmbH together with researchers from Johns Hopkins University Washington, USA. Inostics is also located in Hamburg, Germany. For more details please visit www.inostics.com.
