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Roche's Co-Exclusive License for PI3K Marker Will Aid in Personalization of Genentech Drugs

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In obtaining a license for the PI3K biomarker, Roche plans to investigate at least two investigational oncology drugs with a pharmacogenomic strategy.

Roche announced this week that it has acquired a co-exclusive license for the biomarker from Qiagen. Johns Hopkins University, which owns the patent for the PI3K marker, granted an exclusive license to Qiagen's DxS subsidiary in February.

Roche said the license would allow it to develop real-time and endpoint PCR assays to detect mutations in the PI3K oncogene, which would aid its subsidiary Genentech in the development of several investigational drug candidates.

Phosphatidylinositol-3-kinases are enzymes involved in cell functions related to cancer. The pathway includes the PIK3A oncogene and the PTEN tumor suppressor.

According to a Genentech spokesperson, the company currently has in its pipeline the PI3K inhibitor GDC-0941 and the PI3K/mTOR inhibitor GDC-0980.

GDC-0941, discovered by the Roche-acquired firm Piramed, is in four Phase Ib clinical trials in HER2-positive metastatic breast cancer and metastatic non-small cell lung cancer. Genentech also expects to launch a Phase II study with GDC-0941 as a treatment for estrogen receptor positive metastatic breast cancer in the first quarter of 2011.

Roche's PIK3 test may also be applied in the clinical program for GDC-0980, which was discovered jointly by Genentech and Piramed under a collaboration agreement. This drug is currently in Phase I studies in the treatment for several solid tumors. Genentech also expects to advance this agent into Phase II trials in ER-positive metastatic breast cancer patients in the first quarter of 2011.

"There is abundant clinical evidence that the PI3K biomarker will play a significant role in the future of oncology treatment," Paul Brown, CEO of Roche Molecular Diagnostics, said in a statement. "Diagnostic assays that detect mutations in PI3K will be an essential component of cancer drug development and personalized healthcare."

Although Roche is planning to use its PCR-based tests to detect mutations in the PI3K oncogene and individualize treatment with PIK3 inhibitors, it's unclear if the company's license for the biomarker is restricted to use in clinical trials, or if it extends to the development of commercial tests.

Qiagen subsidiary DxS may also develop PI3K assays under the terms of its licensing agreement with Hopkins.

Qiagen and Roche are already distribution partners for DxS' Therascreen-branded test kits that detect EGFR and KRAS mutations in cancer patients. The two firms recently signed an out-of-court agreement settling a dispute over distribution rights for DxS' suite of tests (PGx Reporter 06/02/10).

The PCR assay being developed by Roche will run on its Cobas 4800 System, which the company said it will make available to internal and external pharmaceutical partners for use in clinical drug trials.

"By applying our vast, global experience in both cancer drug development and molecular diagnostics, we believe we can quickly generate new assays that will provide value to both drug developers and oncology medical professionals,” Brown said in a statement.

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