Inostics Acquires Exclusive License for Detection of Oncogene PIK3CA Mutations

Inostics GmbH (Hamburg, Germany), a subsidiary of Indivumed GmbH (Hamburg, Germany; and Kensington, MD, USA), has obtained a worldwide exclusive license for the detection of PIK3CA mutations from Johns Hopkins University (Baltimore, MD, USA). The company intends to develop DNA-based blood tests for individualizing cancer therapy.

The license grants Inostics the exclusive right to use digital PCR techniques and other technologies such as sequencing to determine PIK3CA mutations. The company's BEAMing technology, a sensitive, digital technology, allows for the selective detection and quantification of mutant DNA. Inostics will be the sole provider to offer tests for the detection of PIK3CA mutations in tissues, plasma, and serum.

BEAMing Technology (beads, emulsions, amplification, and magnetics) is the core of Inostics' technology platform for the rapid and highly sensitive detection and quantification of low abundant mutant tumor DNA molecules in biologic samples. The technology performs amplification of individual DNA fragments covalently linked to magnetic beads. Because the beads are suspended in water-based nanoparticles immersed in oil droplets, the amplification needs only minute amounts of reagents and it can be carried out in a highly paralleled fashion. For example, more than one mutated DNA fragment can be identified among 10,000 nonmutated (normal) fragments. The sensitivity is significantly higher compared to conventional PCR techniques and it enables not only detection but also quantification of tumor-related DNA molecules in samples.

Mutations in the PIK3CA gene could play an important role in tumor cell proliferation as well as in invasion and metastasis. Therefore, 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 including breast and colon cancer. 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 the tests for detection of PIK3CA mutations.

Such a test may be used for companion diagnostics, i.e. to stratify patients once a PIK3CA inhibitor is approved. It may also have a predictive value for patients' response to drugs not specifically targeting PIK3CA. Hartmut Juhl, CEO and cofounder of Indivumed and Inostics, believes that 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."

Inostics GmbH is a molecular diagnostics company providing molecular tools to support individualized cancer patient management and drug development for the benefit of cancer patients. The core competency of Inostics is centered on the detection of genetic changes, such as somatic mutations, in blood or tissue samples from patients.

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Johns Hopkins University