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BioMarker Strategies Seeks Pharma Customers for Tumor Cell Analysis Platform; Eyes Future Dx Development

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NEW YORK (GenomeWeb) – BioMarker Strategies, a company that has spent the last several years advancing a platform that allows various analyses to be performed on live tumor cells, is using a new grant announced last month to develop a test on its platform to guide therapy selection for patients with non-small cell lung cancer.

However, because it anticipates that commercialization of a diagnostic test is still several years off, the company is currently coalescing its business in the shorter term around providing research services to pharmaceutical companies, Jerry Parrott, the company’s president and CEO told GenomeWeb.

"Even if everything goes great with diagnostics development, realistically, we won't see revenues till the next three-to-five-year planning period. So our business [plan] is to provide services … for companies working to develop therapies for solid tumor cancers," Parrott said.

"You can have a really promising candidate and it doesn't wind up working the way you want, raising the question of whether there is something at the pathway level that is contributing to acquired resistance or maybe [a drug] is hitting a different pathway than you intended … those are the kinds of things we can help a company understand, so I think we can have a big role in that area and we are looking for our first customers," he added.

BioMarker's core technology SnapPath is a system that allows automated and standardized analysis of live tumor cells. The platform isolates and purifies these cells using microfluidics and bead-based immunoassays. Users can then apply up to four different therapies against these cells and formalize the resulting pathway-based biomarker signatures to help guide either the development or the use of targeted cancer treatments in clinical practice.

The company published a proof of concept for this in PLoS One in 2012, in which researchers from the company and collaborating academic institutions showed that they could reproducibly determine information on the ex vivo effect of BRAF inhibitors on the MAPK pathway in live human melanoma samples using the platform.

Specifically, the group was able to create profiles that correlated with anticipated MAPK activity based on the known BRAF mutation status, as well as actual observed clinical responses to BRAF inhibitor therapy.

On the diagnostics side, Parrott explained that the system can then be used to develop algorithm-based "PathMap" tests that use patterns of phosphoprotein-based biomarkers created when cells are subjected to different drugs to predict a patient's likelihood of response to that therapy.

Although the company is hoping now to develop partnerships with drug developers to create revenue in the short term, In the longer term, Parrott said that BioMarker is pursuing a number of different PathMap diagnostics with added value over genomic testing or other molecular analyses performed on dead cells.

The company's plan will be to try to advance the resulting tests commercially with partners that it either makes through pharma service contracts or through other avenues, he explained.

According to Parrott, the limitations of genomic analysis alone in predicting response to targeted therapy are well-known, and acknowledged by the genomics community.

"The emerging reality is that you need more than one diagnostic even if you have a very promising or effective new drug because there are situations where you have a patient who has a mutation that makes them eligible and despite the fact that they look [genomically] like they would benefit they don't," Parrott said.

Under its newest research funding — a phase I/II fast track Small Business Innovation Research grant from the National Cancer Institute announced last month — BioMarker is now working on a pathway-based assay, called PathMap NSCLC, that it says will help physicians predict patients' responses to different therapies, including potential drug resistance, and to combinations of different therapies.

The company is currently underway on the six-month, $300,000 Phase I section of the grant. If it meets the appropriate predetermined milestones, the firm will then receive $2 million for Phase II of the project.

BioMarker is calling this planned result a "companion diagnostic," although it does not fit the definition that many entities such as the US Food and Drug Administration use — namely a test designed and approved alongside a specific drug, whose labelling requires use of the test to determine which patients are eligible to receive it.

Instead, PathMap NSCLC would be a test that can inform on multiple different therapies and combinations thereof, Parrott said. He did not provide details on what drugs are being incorporated into the NSCLC test.

BioMarker has also been working on a melanoma diagnostic, for which it received a $1.5 million Phase II SBIR award in 2013.

Overall, Parrott said that the company is hoping to raise money to support development of the SnapPath platform and proof of concept for PathMap tests in a variety of solid tumors including head and neck, colorectal, pancreatic, and breast cancer.