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After Licensing microRNA IP, IntegraGen Aims to Launch Cancer Diagnostic in '14

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French molecular diagnostics firm IntegraGen this week announced that it has acquired the exclusive rights to intellectual property around the use of a specific microRNA — hsa-miR-31-3p — to predict progression-free survival in metastatic colorectal cancer patients treated with epidermal growth factor receptor inhibitors.

With the IP in hand, the company is now on the lookout for a partner that can help it bring to market a test based on the miRNA's expression in the US, potentially before the end of next year, Larry Yost, vice president of IntegraGen's US operations, told Gene Silencing News.

Meanwhile, the company is exploring other cancers treated with anti-EGFR drugs for which miR-31-3p may be a useful biomarker as it works with various academic collaborators on miRNA-focused projects, he added.

IntegraGen was founded in 2000 to develop genetic-based tests for determining people's risk of developing metabolic diseases such as obesity and diabetes. And while it still holds IP in those areas, the firm encountered difficulties identifying commercial opportunities, according to Yost.

"For example, if you identify somebody who is at risk of being obese, what do you do with that information," he said. "You need to diet and exercise, but where is the clinical utility?"

After considering the opportunities for molecular diagnostics in different indications, the company began focusing on autism — a disorder for which it has already brought a test to market — and oncology.

As part of its work in cancer, IntegraGen began working with the French League Against Cancer to develop a gene-expression panel that can be used to predict liver cancer patient prognosis. The success of that alliance led the company to formally establish a unit to offer similar services to customers.

IntegraGen began providing genomic services to Descartes University Medical School researcher Pierre Laurent-Puig to support his research into miRNA expression and cancer, and ultimately acquired the rights to his research on miR-31-3p.

In addition to Descartes University, the French Institute of Health and Medical Research, the French National Center for Scientific Research, and the Public Support Hospitals of Paris also licensed their rights to the IP to IntegraGen.

Earlier this year, Laurent-Puig and collaborators presented data at the European Society for Medical Oncology's annual meeting on the use of miR-31-3p to predict metastatic colorectal cancer, or mCRC, patient response to anti-EGFR therapy.

Mutations in the KRAS gene are known to trigger resistance to EGFR inhibitors, according to a poster from the meeting. As part of an effort to find biomarkers that could predict responses to these drugs in wild-type KRAS mCRC patients, the researchers extracted and analyzed RNA from fresh frozen tumor samples from 43 patients randomly chosen from two separate training sets.

In those studies, miR-31-3p displayed a significant association with progression-free survival, prompting additional investigation.

Laurent-Puig and his colleagues then expanded their study to include an additional 89 KRAS wild-type CRC patients, and found that mCRC patients with poor prognosis overexpressed miR-31-3p and showed no response to anti-EGFR therapy, according to the ESMO poster.

Despite these promising results, Yost said that IntegraGen is planning to conduct additional validation studies in larger numbers of mCRC patients, hopefully replicating the data already generated.

When it comes to bringing a diagnostic to market and securing reimbursement from insurers, "it's important to have a larger patient experience," he noted. "While the data we have right now look really good, we would like to solidify that a little bit."

Additional positive data is also expected to help IntegraGen find the partner it needs to commercialize its test in the US, he said. Earlier this year, the company inked a deal with Lab21, which is providing support on securing regulatory approval in Europe. Since then, the molecular diagnostics operations of Lab21 were acquired by Trinity Biotech, which is now working with IntegraGen.

In the US, however, IntegraGen is looking for a partner with a CLIA-certified laboratory, as well as experience in oncology and an established sales team, to bring the test to market. The company hopes to do so in the second half of 2014.

Although miRNAs are not its core focus, IntegraGen is advancing other projects based on the small, non-coding RNAs, Yost said.

The company provides miRNA profiling services to a number of academic groups, which could eventually lead to deals similar to the one with Laurent-Puig that resulted in the miR-31-3p license, he noted.

"We are also looking at the miR-31-3p in other cancers where there is the use of anti-EGFR therapies," he added, although this work is still preliminary.

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