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Caprion Leading $21M Clinical Biomarker and Personalized Medicine Development Project

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Caprion Proteome is leading a four-year, C$21 million (US$20.5 million) public-private partnership focused on development and implementation of clinical biomarkers and personalized medicine strategies for oncology.

Funded by $10 million from the Quebec government and $11 million from private sector participants including Caprion, Pfizer, Sanofi, Oncozyme Pharma, and TELUS Health, the initiative, named the Personalized Medicine Partnership for Cancer, will use proteomic and genomic approaches to develop, deploy, and test biomarkers and therapies for lung, colon, and breast cancer.

Other partners include the Quebec Clinical Research Organization in Cancer, a network of clinicians, academics, and other members of the medical community working in clinical and translational cancer research.

Caprion, which is headquartered in Montreal and has a facility in Menlo Park, Calif., will coordinate the project's private sector partners and a network of around 16 Quebec hospitals whose patient populations will be used for the project's clinical studies, CEO Martin LeBlanc told ProteoMonitor.

"We are offering the [private sector] partners the ability to tap into this clinical network in Quebec to recruit patients, collect samples, and use all of the pathology services provided through this network," he said. "We are basically coordinating the overall effort … acting as a sort of gatekeeper, the representative of the pharma [firms] to this [hospital] network."

A major focus of the partnership is on pharmacoeconomic testing of certain companion diagnostic biomarker panels, LeBlanc said, noting that Caprion would work with the project's pharma partners to run "real world pharmacoeconomic studies that track patient outcomes and [perform] actual economic evaluations of the biomarkers and the drugs to demonstrate the pharmacoeconomic benefits of these [tests]."

Such trials could help accelerate the efforts of pharma firms to obtain regulatory approval and reimbursement within Quebec for these diagnostics, he said.

In addition, Caprion plans to use the initiative to move its own proteomic tests into the clinic, LeBlanc said, adding that the company would be using some of the funding to establish a CLIA lab to develop and run multiple-reaction monitoring mass spec-based proteomic diagnostics.

In a July interview with ProteoMonitor, LeBlanc said he felt MRM-MS was "ready for prime time" as a clinical tool (PM 7/27/2012), a sentiment recently echoed by other proteomics researchers (PM 2/15/2013).

"We believe that with the recent [improvements] in instrumentation, the sensitivity and reproducibility [of the technique] is there," he said. "If you have a good operation that has all the QA/QC, we believe the results rival an immunoassay."

The company does its MRM work on AB Sciex 5500 and 6500 QTRAP instruments as well as on an Agilent 6490 machine. It uses a Thermo Fisher Scientific Q Exactive for most of its discovery work, LeBlanc said.

Within the PMPC project, Caprion's efforts will focus on validation of a lung cancer test it is developing in collaboration with Integrated Diagnostics.

"What we're doing is leveraging the access [provided by the PMPC] to a broader sample population to conduct further prospective validation of the test using MRM-MS and ultimately generate real-world data in the Quebec healthcare system to help justify commercialization and reimbursement in Quebec," LeBlanc said.

InDi plans to launch the US version of the diagnostic this year (PM 1/13/2012). According to LeBlanc, Caprion aims to complete its CLIA lab either by late this year or early 2014, and launch a Canadian version of the lung cancer test in 2014.

The PMPC initiative, LeBlanc said, is key to this effort and the pharmacoeconomic studies in that it provides both funding and a single-payer healthcare system where Caprion and its partners can more easily coordinate and run clinical trials.

"This [work] is mostly going to [use] prospective [sample] collection and will leverage the healthcare system of Quebec," which offers a population of roughly 7 million patients, he said. "So it's a very powerful clinical network in terms of access to patients."

Beyond this patient access, the system will allow the researchers to "harmonize procedures for patient selection, for post-approval data collection on outcomes, and for [obtaining] single ethical approval across all these hospitals," LeBlanc said.

"We're trying to … make the system behave like one single system so we can actually execute on clinical trials in personalized medicine and oncology much faster," he said, adding that the group had already made significant progress in this area.

Separate from the PMPC project and lung cancer work, Caprion is developing proteomic diagnostics for tuberculosis, brucellosis, and diabetes, the latter of which it also plans to bring to market in 2014 as an MRM-MS-based laboratory-developed test. The test is intended to predict the onset of diabetes as well as measure disease progression and monitor response to treatment.

The regulatory status of LDTs in the US remains somewhat uncertain with the US Food and Drug Administration maintaining – despite its hands-off approach to date – that such tests fall under its authority (PGx Reporter 2/13/2013). This is less a concern in Canada, however, LeBlanc said, noting that "there is no talk in Canada of further regulating [LDTs]."

He added that despite FDA's statements, he is "not sure even how early it will be that the US will go down the route of regulating" such tests. "I know there is talk of it, but there has not been any sort of what I would call proactive moves made as of yet. But I think were that to happen, Canada would probably be a little further behind the US in taking such steps."

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