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Provista Licenses Markers from Biodesign Institute to Support Breast, Ovarian Cancer Dx Efforts

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Provista Diagnostics said last week that it has signed a licensing agreement for protein biomarkers developed by researchers at Arizona State University's Biodesign Institute.

The agreement covers biomarkers for the early detection of breast and ovarian cancer and human papillomavirus identified in the labs of Biodesign Institute researchers Joshua LaBaer and Karen Anderson. Both researchers are members of Provista's scientific advisory board.

According to President and CEO David Reese, the company plans to evaluate the markers for use in biomarker panels it currently has under development internally. In particular, he said, the company hopes the licensed markers will aid its work on a test for the early detection of breast cancer. The agreement includes 28 auto-antibody markers to the disease identified by LaBaer's lab.

Beyond the actual assets Provista has obtained by the license, the agreement also represents a vote of confidence of sorts for the company, Reese suggested, noting that given LaBaer and Anderson's stature as researchers, "they could have gone to anybody to develop these markers."

Provista's "thoughtful" approach to biomarker development made the company an attractive firm for licensing his lab's markers, LaBaer told ProteoMonitor.

"It was very attractive to me that they are being very cautious about how they are doing their [clinical] studies and so on," he said. "I really liked the approach that [Reese] is taking."

Provista's history hasn't always been one of focused, deliberate efforts. The company launched in 2004 as Provista Life Sciences, positioning itself as a mezzanine developer of molecular diagnostics that aimed to acquire early-stage biomarker tests, advance them to the clinical stage, and then sell them.

It developed in this manner a diagnostics pipeline covering a number of disease areas including Alzheimer's, Parkinson's, ovarian cancer, and lung cancer. It also developed a breast cancer test called the BT Test, selling it in Ireland and the UK through International Health Technology.

Reese, who has a PhD in biomedical sciences from Vanderbilt University and prior to joining Provista worked at the hedge funds Brencourt Advisors and Yorkville Advisors, became involved with the company as an investor in 2011.

In August 2011, he joined Provista as CEO, whereupon he moved to divide the company in two, spinning out its central nervous system assets into a new company, Memory DX, and establishing its current focus on women's cancers.

In May 2012, the company opened a CLIA-certified, GLP-capable laboratory in Scottsdale, Ariz., out of which it launched a contract research business in October of that year. In January 2013, Provista launched a 350-patient prospective trial for its breast cancer early detection test, now called DtectDx Breast (PM 1/25/2013). The company is now in the process of enrolling patients for a second prospective trial for the test, this one consisting of 350 subjects across eight different clinical sites.

It plans to launch additional clinical trials in different patient populations for the test over the next several quarters, Reese told ProteoMonitor, noting that such trials are important due to the heterogeneity of the disease.

"We are increasingly learning that if, say, a patient is a BRCA carrier, detecting a tumor in that patient may be different from detecting one in [a patient] who is not a BRCA carrier," he noted. He said that the company would potentially test the breast cancer markers licensed from LaBaer's lab in samples from all of the aforementioned trials.

These markers, 28 auto-antibodies, originate from research using LaBaer's nucleic acid programmable protein array platform, which uses proteins synthesized in situ directly from printed cDNA vectors at the time of the assay to create large arrays.

In a 2010 study in the Journal of Proteome Research, LaBaer and his colleagues identified the 28 markers from a panel of 5,000 antigens, testing them in a blinded study using 50 cases and 39 benign controls (PM 12/24/2010). In that study, each of the biomarkers demonstrated specificity ranging between 75 percent and 100 percent with sensitivities in the 10 percent to 40 percent range.

These 28 markers, LaBaer said, now require validation in additional cohorts and in outside facilities, and the Provista deal "is a great opportunity to do that."

The company's CLIA lab "is really well set up to take assays that other people have built in more research-like labs like mine and make them more bullet-proof and then do more carefully developed clinical trials," he said.

"We don't want these to be markers that just die on the vine," LaBaer said, adding that the markers are also undergoing validation in an ongoing trial run through the National Cancer Institute's Early Detection Research Network.

"If you think about the power of adding [the two panels] together, you could think about a next-generation version [of the DtectDx Breast test] that works in populations that our current panel is not as robust in," Reese said. "The other thing it does in the breast arena is that, some of our markers are hormone sensitive so we need a different algorithm for women under 50 as opposed to over 50. The hope is that by combining our panel with their panel we can develop a panel where there is one algorithm regardless of age or menopausal status."

Reese said Provista aims to complete clinical trials for DtectDx Breast over the next 12 to 18 months and launch an initial version of the test out of its CLIA lab. The company plans ultimately to apply for US Food and Drug Administration 510(k) clearance for the test, he added.

The license agreement also provides Provista rights to protein biomarkers for ovarian cancer and HPV, though Reese noted that these efforts are earlier stage than the company's breast cancer work.

Provista raised $7.5 million in 2012 and an additional $6 million this April. Reese noted that the company's services business helps it control its cash burn and, as such, it had no immediate plans to raise new funds to support its breast cancer work.

However, he said, "depending on the robustness of the data coming from this second prospective trial, you could imagine a national launch [for the DtectDx Breast test]. And clearly the capital we have in the bank would not be sufficient to conduct a high quality national launch."

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