By Ben Butkus
MicroParticle Proteomics said last week that it has exclusively licensed a blood-based biomarker from the University of Virginia Patent Foundation that could serve as the basis for diagnostic and prognostic tests for cardiovascular disease and ischemic heart failure.
The biomarker was discovered by former UVA researcher and company co-founder Klaus Ley using a proteomics platform that he also developed while at the university and upon which MPP was founded.
MPP, based in La Jolla, Calif., also owns the rights to a patent covering the platform technology, which it obtained directly from Ley after UVAPF assigned it back to him when he left the university in 2007.
With both a methods patent and its first biomarker in hand, MPP is now seeking investors or development partners to help conduct additional clinical studies for MPP-CV2, which the company said could help physicians identify high-risk cardiac patients and tailor their treatments.
The company said that MPP-CV2 can identify post-coronary artery repair patients who are at greatest risk of serious adverse outcomes, such as myocardial infarction, stroke, or death, following a recent intervention.
In an unpublished proof-of-concept study of 77 patients using an ELISA assay format, the marker correctly predicted patients at risk of serious cardiovascular events following coronary angioplasty, according to the company.
MPP also said that in an early clinical trial MPP-CV2 was used to identify patients with ischemic heart failure that were at increased mortality risk.
The company said that there are more than 1.3 million coronary vascular repair procedures performed annually in the US, and up to 20 percent of patients undergoing vessel repair experience serious adverse outcomes in the first year.
In addition, MPP said that more than 5 million patients are diagnosed with heart failure in the US, and that 60 percent of those suffer ischemic heart failure, which is associated with 10 percent to 15 percent mortality in the first year.
"We demonstrated in two small patient trials that we could ID patients that are at risk following coronary artery repair, and the same with patients diagnosed with ischemic heart failure," Jack DeFranco, CEO of MPP, told BTW last week. "The significance of this is that a physician may now be able to ID patients at risk, and adjust their treatments accordingly."
Ley, who is currently head of autoimmune research and inflammation biology at the La Jolla Institute of Allergy and Immunology, developed the underlying proteomics method used to discover the biomarker while he was employed by UVA. The method examines a sub-fraction of plasma using high-performance liquid chromatography followed by tandem mass spectrometry, Ley told BTW last week.
UVA filed a US patent application in 2007 for the method on Ley's behalf, and was awarded US patent No. 7,462,489 in December 2008. The patent also names as a co-inventor David Smalley, a colleague of Ley's at the time.
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However, prior to Ley's departure from UVA in 2007, the university assigned the rights to the patent back to Ley, apparently unable to find a licensee or potential development partner.
"This patent is essentially the platform technology at MPP, and that patent has issued," Ley said. "It was returned to me by UVA Patent Foundation because they didn't see the value in it."
Mikael Herlevsen, the licensing associate for UVAPF that negotiated the MPP deal, told BTW that it is the foundation's policy to assign rights to a patent back to the inventor if it cannot license it or find sufficient outside interest within the year that the provisional patent is pending.
What is unusual is that the faculty inventor take the patent and pursue his own commercialization route, Herlevsen said. "We gauge the strength of the patent by asking industry whether it is valuable to them," Herlevsen said. "We try to make the process as transparent as possible so the inventor receives the feedback from industry."
Ley remained determined to seek development partners for his discovery platform on the West coast, which he found through the San Diego Connect Springboard program, a public-private partnership that pairs promising academic technologies and inventors with entrepreneurs and commercialization resources.
DeFranco was an entrepreneur-in-residence at the time, and struck a partnership with Ley to form MPP as a vehicle for commercializing the biomarker-discovery method.
As part of the company's founding, Ley essentially donated the patent to MPP, and has a vested interest in its development as a shareholder in the company. He is also serving as MPP's chief medical officer and is a member of its scientific advisory board. The co-inventor, Smalley, has also received a "small ownership interest" in MPP, Ley said.
"The assignment of the patent was essentially the founding event for MPP," Ley said.
In the meantime, UVA had filed several additional patent applications based on Ley's work for specific biomarkers that he unearthed using the method.
One of those patent applications, which is still pending, covered the MPP-CV2 biomarker that MPP recently licensed. UVA exclusively licensed another biomarker for a disease called abdominal aortic aneurism to Johnson & Johnson company OrthoDiagnostics prior to MPP's formation.
Herlevsen said that in general, it is a bit easier to license specific disease biomarkers than it is a broad-based discovery platform. "And it's not that the platform doesn't have as much value; it could be that it's just more suited for a startup company," Herlevsen said.
"UVA had several patents that came out of his technology," DeFranco said. "We were interested in this one because we were particularly interested in cardiovascular disease."
Financial terms of MPP's licensing agreement with UVA have not been disclosed. However, DeFranco said that the agreement was "fairly standard," comprising an undisclosed up-front payment, milestones, and royalties.
MPP is currently funded through founder stock and friends and family, DeFranco said, and the company is now seeking additional venture capital as well as a partnership with a biotech or pharmaceutical company that may be interested in conducting the next series of clinical trials for MPP-CV2.
Meanwhile, Ley's lab at LIAA is studying the mechanism of action of various biomarkers discovered using the proteomics method. "When you have a biomarker it can sometimes be very helpful to know why it works," Ley said.
He also predicted that the work will likely yield additional patents in the future, which perhaps could be of interest to MPP. The company does not have a formal research relationship with Ley's lab or LIAA, however.