Biotech firm Amarantus Biosciences said this week it has licensed Power3 Medical Products' NuroPro protein biomarker platform to support its research into therapeutics and diagnostics for Parkinson's disease.
For Power3 the deal marks a resumption of activity of sorts, as the proteomics outfit emerges from a two year breach-of-contract suit with Transgenomic that the parties settled earlier this month (GWDN 1/9/2012).
Power3 now aims to use its 2D gel-based proteomics platform for contract research work while also internally developing the NuroPro test – a panel of 57 proteins in serum linked to neurodegenerative disorders including Parkinson's, Alzheimer's, and amyotrophic lateral sclerosis – and its SeraPro breast cancer diagnostic, interim CEO Helen Park told ProteoMonitor.
The company had largely halted its protein biomarker development efforts during the Transgenomic lawsuit, Park said, noting that it "couldn't move forward until we settled [the suit], and that went on for two years."
Transgenomic sued Power3 in February 2010 after Power3 terminated an agreement that gave Transgenomic marketing rights to the NuroPro test (PM 2/26/2010).
In the suit, Transgenomic said Power3 had made "false representations" about its tests while negotiating the deal. Specifically, it asserted that Power3 presented data claiming that the NuroPro test had specificity and sensitivity of 100 percent for Alzheimer's disease as well as sensitivity of 94.9 percent and specificity of 95.5 percent for Parkinson's disease. Transgenomic was unable to validate these results in later tests.
Transgenomic also asserted that Power3 had committed libel and slander by issuing a press release accusing Transgenomic of breach of contract. This action, the company charged, inflicted more than $520,000 in damages and caused a 9 percent drop in its stock price and a loss of more than $2 million in market capitalization.
This month the two companies reached a settlement through a mediated agreement in the US District Court for the District of Nebraska that called for Power 3 to retain all commercial rights covered by the deal and to give Transgenomic an equity payment of undisclosed value.
Amarantus has now licensed the NuroPro test and plans to use it internally to select clinical trial cohorts for its Parkinson's therapeutic program, which is focused on the molecule mesensephalic-astrocyte-derived neurotrophic factor, or MANF, Gerald Commissiong, the company's president and CEO, told ProteoMonitor.
Amarantus also hopes to develop NuroPro into a commercial test that could be used to diagnose Parkinson's as well as track response to treatment, Commissiong said. The company would initially target such a product to pharma firms looking to reposition existing drugs as Parkinson's therapeutics.
Such a test "would be attractive for phase IV clinical studies for drugs already on the market and seeking a modified label," he said. "One of the big problems that has been seen in [such studies] is that it's impossible without a biomarker to really objectively come up with a trial design that definitely says that a specific drug has the disease-modifying profile."
"So from a commercial standpoint we think if this proves out we'll be able to start selling kits – first to big pharma [firms] who are running these phase IV studies" and then more broadly as a clinical diagnostic for the disease, Commissiong said.
Assuming the proteins in the NuroPro panel do prove suitable for such purposes, Amarantus would likely convert the test to an ELISA format, he added. It would offer it first as a laboratory-based test and then, using data generated by these customers, submit it to the US Food and Drug Administration.
Commissiong said he was aware of the Trangenomic suit and the controversy that had surrounded Power3's data on NuroPro's performance, but, he said, Amarantus had done "very in-depth due diligence" on the test. He added that the structure of the deal limited the firm's risk.
Under the agreement, Amarantus has an exclusive license to develop and sell products using Power3's Parkinson's disease intellectual property. The company paid Power3 a $25,000 exclusivity fee in common stock on Nov. 11, 2011, and will issue it another $475,000 worth of common stock. It also has the option to purchase all of Power3's Parkinson's IP for $500,000 in common stock and a right of first refusal to buy the rest of the NuroPro platform for other neurodegenerative diseases including Alzheimer's and ALS.
"We feel that [the agreement] is somewhat risk-neutral on both sides," Commissiong said. Power3 is "looking for a way to partner this technology off, which is why we did a stock deal. To the extent that their technology performs, then the value of our stock increases and they will have upside on their balance sheet – that's how they get their win. If their technology doesn't perform, then the stock is returned to Amarantus."
The NuroPro test consists of 57 serum proteins, but the Amarantus agreement will focus on the development of a subset of 21 linked specifically to Parkinson's. The company plans to start a clinical validation study on the markers in the first half of this year, partnering with Power3 on the trial.
That work will help Power3 establish its CRO business, which, Park said, the company intends to use to support in-house protein biomarker research, including continued work on NuroPro and SeraPro.
CRO work will provide "continuing income" for the company as well as "a way of meeting new partners who may want to develop protein biomarker assays," she said, adding that the company planned to raise new funds to support this work.
Concurrent with the Power3 agreement, Amarantus announced it had raised $100,000 from a private investor. In April 2010 it received a $370,716 grant from the Michael J. Fox Foundation for Parkinson’s Research.
The Power3 deal is Amarantus' second biomarker deal in recent months. In November, it signed an agreement with Banyan Biomarkers to use that company's protein biomarker-based test for traumatic brain injury to evaluate MANF's potential as a TBI treatment. It also said it plans to use Banyan's neurotoxicity biomarker panel to test the safety of the drug.
Have topics you'd like to see covered in ProteoMonitor? Contact the editor at abonislawski [at] genomeweb [.] com.