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Transgenomic Hopes to Attract Pharma Partners with Exclusive License to PIK3CA/PTEN PGx Testing

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Originally published May 31.

By Turna Ray

Looking to bolster its pharmacogenomics services to pharmaceutical partners, Transgenomic has secured an exclusive worldwide license to intellectual property held by Montefiore Medical Center for methods to detect mutations in the PIK3CA and PTEN genes.

Transgenomic last week announced it had garnered exclusive rights to a patent, titled "Method of determining the sensitivity of cancer cells to EGFR inhibitors including cetuximab, panitumumab and erlotinib." The patent application (No. 20090258364) was filed by Montefiore Medical Center's Sanjay Goel and John Mariadason, who discovered the association between mutations in the PIK3CA and PTEN genes and a lack of response to EGFR inhibitors, such as Bristol-Myers Squibb/Merck/Lilly/ImClone's Erbitux, Amgen's Vectibix, and Genentech/OSI's Tarceva.

According to the US Patent and Trademark Office's database, the application has not yet been awarded.

The patent application describes a means of "determining if a cancer patient is amenable to treatment with EGFR inhibitors including but not limited to cetuximab, panitumumab or erlotinib." The methods claimed involve "obtaining cells from a [colon] cancer patient's tumor," isolating the DNA from the tumor tissue, and sequencing the isolated DNA for mutations in the PIK3CA and PTEN genes, assessing if the tumor tissue expresses the PTEN protein, and making a determination as to whether the patient's expression or mutation status makes them responsive or resistant to EGFR-inhibitor treatment with these two drugs.

Additional claims in the patent describe assessing any mutation in the PIK2CA/PTEN pathway by the method described above when gauging drug response to any EGFR inhibitor when the patient has not just colon cancer, but also gastric, lung, or breast cancer.

Transgenomic plans to test for these genomic markers linked to drug response with its own mutation detection technologies.

"Testing of these genes is … being offered to support drug development research by pharmaceutical companies that have been expressing great interest in these genes and in Transgenomic's proprietary, ultra-sensitive mutation-detection technologies," the company said.

Transgenomic's diagnostic portfolio includes Ice COLD-PCR and BLOCker sequencing technologies, and CEO Craig Tuttle has previously claimed the drug developers are particularly interested in applying these technologies in their PGx-guided drug development work.

"This exclusive license from Montefiore strengthens our cancer-related diagnostic test portfolio and is integral to the continued development of our leadership position in oncology," Tuttle said in a statement.

Earlier this month, Transgenomic reported a 22 percent drop in revenues for its pharmacogenomics services business in the first quarter of 2011. However, during a call with analysts regarding the company's quarterly earnings, Tuttle was optimistic that the PGx services segment will contribute significantly to Transgenomics' growth in the coming months as a number of newly signed genomic testing arrangements with pharmaceutical companies start to bring in money (PGx Reporter 05/18/2011).

With the new license, Transgenomic will be able to offer PGx services for EGFR inhibitors, a market that's already primed with the adoption of KRAS mutation testing in colorectal cancer. Currently, the labeling for Vectibix and Erbitux both recommend that patients with mutations in the KRAS gene do not receive these drugs. Qiagen's DxS subsidiary is in the process of garnering premarket approval for a companion diagnostic that gauges best responders to Erbitux and Vectibix, and will be marketed alongside these drugs.

The labeling for these drugs does not include any information regarding administration for patients with PIK3CA or PTAN mutations.

Qiagen currently markets a real time-PCR based PIK3CA Mutation Test Kit, and has services for gauging PTEN gene/protein expression, methylation, siRNAs, and mutations through RT-PCR and long-range PCR.

Some other companies that offer testing for these gene markers include Ambry, Arup, and Quest.

It is unclear whether Transgenomic has tracked the market for companies that may be infringing its license, and it is unknown to the degree which the company plans to enforce its exclusive rights.

Transgenomic did not answer questions ahead of press time.


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