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Myriad RBM Collaborating with Sanofi on Protein Biomarkers for Diabetes Diagnosis, Drug Response

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Myriad RBM said this week that it has signed a collaboration agreement with pharma firm Sanofi and Canada's Population Health Research Institute to explore protein biomarkers linked to diabetes.

Under the agreement, Myriad RBM will run more than 8,000 serum samples from the Outcome Reduction with Initial Glargine Intervention, or ORIGIN, diabetes study on its DiscoveryMAP 250+ immunoassay panel.

The project will take roughly two years and could net Myriad RBM up to $10 million, the company said. If data from the initial 8,000 samples is promising, the collaboration could be expanded to analyze longitudinal samples collected as part of the ORIGIN study, Myriad RBM CEO Craig Benson told ProteoMonitor.

The collaboration aims to identify biomarkers both for susceptibility to and early detection of diabetes, as well as for identifying likely responders to insulin glargine and monitoring response to the drug.

Launched by Sanofi in 2003, the ORIGIN study followed 12,500 individuals with pre-diabetes or early type 2 diabetes for six years, tracking cardiovascular outcomes in patients treated with insulin glargine – a long-acting insulin marketed by Sanofi as Lantus – versus patients treated with standard of care. The study has been managed by researchers at PHRI, a joint institute of Hamilton Health and Sciences and McMaster University.

While Myriad RBM offers a smaller 50-biomarker discovery panel focused on diabetes and metabolic disorders, it will be using its full DiscoveryMAP 250+ panel for the Sanofi project, Mike Spain, the company's chief medical officer, told ProteoMonitor.

"The markers that diagnose a disease may not necessarily be the same ones that predict response to drug," he said. "Sanofi wanted to cast a wide net, because a lot of this [biology] is not known."

This broad approach is particularly suitable given the wide range of biological systems affected by diabetes, Spain noted.

"Diabetics get neuropathies, retinopathy, [and] cardiovascular and kidney disease," he said. "They have an increased incidence of depression, an increased incidence of Alzheimer's, so there's a plethora of things that will be looked at. Optimally we hope to find [protein marker] patterns that are different for these different systems."

The ORIGIN study collected serum samples at zero, two, and seven years. The current agreement calls for Myriad RBM to run the baseline samples only, with the PHRI researchers then analyzing that data to look for any correlations with diabetes-related outcomes. Depending on their findings, the collaborators could then move to an analysis of the two- and seven-year samples.

The $10 million figure Myriad RBM gave as the potential revenues for the project cover only measurement of the baseline samples, Benson said. Myriad has given a guidance of $25 million to $28 million for 2013 revenues from companion diagnostics, the bulk of which will come from the Myriad RBM subsidiary.

Myriad RBM declined to comment on whether it hoped to develop proprietary diagnostics based on the collaboration or which party would own any intellectual property that emerged from the work.

Diabetes is a primary area of focus for Myriad RBM. When the division was established in 2011 upon Myriad's purchase of Rules-Based Medicine (PM 4/29/2011), Myriad targeted five protein biomarker tests in RBM's pipeline as high priority for commercialization, among them a test for the early detection of kidney damage in diabetics.

Several other proteomics firms have also entered the diabetes space. Caprion Proteomics, which was acquired in July by private equity firm Chicago Growth Partners (PM 7/27/2012), counts its diabetes biomarker panel as one of its lead products under development.

Unlike Myriad RBM, which uses an immunoassay-based platform, Caprion is developing its diabetes panel using multiple-reaction monitoring mass spectrometry and plans to offer it as a laboratory-developed test in a CLIA lab it plans to open sometime in 2013.

The company is developing a test that can be used to predict the onset of diabetes as well as measure disease progression and monitor response to treatment. It hopes to finalize the proteins used in the test by the beginning of next year, after which it will work to optimize clinical mass spec workflows for the selected proteins.

Proteomics firm KineMed also has a diabetes program underway. In February, the company signed a research collaboration agreement with Pfizer to use its Dynamic Proteomics platform to study the impact of drug candidates on various metabolic pathways related to the disease (PM 2/3/2012).

The Dynamic Proteomics platform uses wide-scale isotopic labeling combined with mass spectrometry to track the kinetics of protein activity. In addition to the Pfizer collaboration, KineMed has also used its technology for several other studies into diabetes treatments.

In February, it published a study in Diabetologia investigating the mechanisms of glucose lowering with the diabetes drug colesevelam – marketed as Welchol by Daiichi Sankyo, which funded the project.

In 2008 it published a study in the Journal of Lipid Research funded by Takeda Pharmaceutical North America on the effects of the drugs pioglitazone and rosiglitazone – marketed, respectively, by Takeda as Actos and by GlaxoSmithKline as Avandia – on lipogenesis in type 2 diabetes.

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