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Biodesix Inks Deal to Test Veristrat in Phase III Clinical Trial for Kadmon Lung Cancer Drug

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By Adam Bonislawski

Biodesix said this week that it is collaborating with pharma firm Kadmon on a 620-patient Phase III clinical trial of that company's reversible tyrosine kinase inhibitor KD019.

The collaboration will explore the usefulness of Biodesix's proteomics-based Veristrat test for identifying non-small cell lung cancer patients likely to respond to the drug.

The agreement is part of the company's larger strategy of partnering with pharma and biotech firms on clinical trials to increase Veristrat's adoption and bolster clinical data on the test, Paul Beresford, vice president of business development and strategic marketing at Biodesix, told ProteoMonitor. He added that the company has signed 14 deals with pharma and biotech firms to collaborate using the test.

Veristrat is a serum proteomic test that Biodesix has positioned primarily for use in identifying non-small cell lung cancer patients who are good candidates for treatment with EGFR inhibitors. As Beresford noted, however, the company is also exploring its utility with other types of drugs and in other indications.

"We've seen the test work for different EGFR inhibitors, including small molecules like [Genentech's] Tarceva and gefitinib [marketed by AstraZeneca as Iressa] as well as antibodies like [Bristol-Myers Squibb and Merck's] Erbitux," he said. "And then we've also seen interesting applicability across other [agents]."

He cited in particular results the company recently presented from a collaboration with GlaxoSmithKline evaluating the test to identify breast cancer patients likely to benefit from treatment with either Novartis' aromatase inhibitor Femara or Femara plus the GSK tyrosine kinase inhibitor Tykerb (PM 12/16/2011).

In that study, Biodesix used Veristrat to examine pretreatment serum samples from 1,041 patients enrolled in the Phase III trial EGF30008, which compared Femara plus placebo to Femara plus Tykerb in first-line, hormone receptor-positive, advanced breast cancer patients. Patients in the Femara/placebo arm who tested Veristrat “Good” had a median progression-free survival of 10.8 months compared to 2.8 months for patients who tested Veristrat “Poor.”

In the Femara/Tykerb arm, patients who tested Veristrat “Good” showed PFS of 11.4 months and patients who tested Veristrat “Poor” showed PFS of 11 months.

In addition to its breast cancer work with GSK, Biodesix has ongoing collaborations in other disease areas including colorectal cancer and renal cell carcinoma, Beresford said. All told, it has collected data on Veristrat from more than 2,500 patients across 25 clinical trials.

Advanced NSCLC remains the company's current primary focus, though, Beresford noted. "Essentially, the clinical positioning is to use [Veristrat] in advanced non-small cell lung cancer patients when doctors are trying to decide between single agent chemotherapy or Tarceva," he said. "That's where we have the most clinical data. That's our strongest area and where we've been commercializing the test, where we have a sales force in the field."

The company recently completed enrollment for its PROSE prospective trial, which will evaluate Veristrat in investigations of 275 NSCLC patients, comparing treatment with Tarceva versus standard of care. It aims to present the results of the study at a meeting in either the latter half of this year or early 2013, Beresford said.

Although Veristrat is the only proteomic companion diagnostic for NSCLC currently on the market, several firms, including Lab21 and Abbott, offer gene-based companion diagnostics for drugs that target molecules beyond EGFR. Last summer, the US Food and Drug Administration cleared Abbott's companion diagnostic for Pfizer's NSCLC drug Xalkori, an ALK inhibitor. That test identifies patients likely to respond to the drug based on rearrangements of the EML4-ALK gene. Last month, Lab21 began offering a similar test for identifying EML4-ALK translocations in NSCLC patients.

Neither test targets EGFR. However, Lab21 also offers EGFR mutation analysis that can be used to guide NSCLC therapy.

In addition, a number of firms offer tests for mutations in the KRAS gene that have been associated with a lack of response to gefitinib and erlotinib. Qiagen is currently seeking US Food and Drug Administration approval for a companion KRAS test for these drugs.

Biodesix offers Veristrat, which it launched in 2009, as a laboratory-developed test out of its CLIA lab. The test is currently covered by two private payors and the company is pursuing Medicare and Medicaid reimbursement.

"Reimbursement is a very large focus for the company, and our hope is to really drive toward getting [Medicare] reimbursement in the next 12 to 18 months," Beresford said.

Biodesix closed a $20 million Series D financing round in June and plans to raise another round this year to continue its Veristrat commercialization efforts.

The company also has several early-stage projects in its pipeline that it halted several years ago to focus on Veristrat, Beresford noted.

"This year we've kind of gone back to those early-stage projects and dusted them off to look at whether we'll moved forward with them," he said.

Among these projects, Beresford said, is a screening test for patients at high risk for developing lung cancer that could be used to determine whether nodules detected via imaging techniques like CT scans are likely malignant or benign. Such tests have been an area of focus for proteomics firms of late, with companies including Integrated Diagnostics and Somalogic pursuing diagnostics for this purpose (PM 2/24/2012).

Given the amount of investment needed to bring screening tests to market, however, Biodesix is reluctant to pursue that route on its own, Beresford said.

"It takes such a long time to get commercial adoption of screening tests, so it's something that we would consider, but [we would] probably do it in partnership with a larger company or an entity like [the National Cancer Institute]," he said.

Like Veristrat, Biodesix's other work is based on a MALDI mass spec platform, specifically Bruker's autoflex instruments. While MALDI-MS is currently undergoing something of a revival as a clinical proteomics platform (PM 1/20/2012), Beresford said that MALDI's reputation had presented a certain challenge for the company in terms of promoting its clinical platform.

"We're pretty much out on a limb here," he said. "There aren't a lot of people using MALDI as a key clinical tool. It's been a bit of a headwind to convince people that we have real clinical data and ultimately that this platform has legs."

Although MALDI has a reputation for high variability, Biodesix's assays have coefficients of variation in the 2 percent to 3 percent range, Beresford noted. In addition, he said, the platform allows for very simple sample prep and high throughput.

"We do a very simple [sample prep] process called 'dilute and shoot' that leads to this reproducibility," Beresford said. "We simply dilute the sample in water, mix it with matrix, and spot it on a plate. So there's not a lot of sample manipulation."

The high throughput of the approach is another advantage, he added. "You go straight to the serum sample and establish clinical utility very quickly. So you fail quick and you fail early if you don't land on anything."

The company's " pitch" to potential pharma partners is that "we'll work with you in a collaborative mode; we'll get this done very quickly; and while we can't guarantee we're going to find something clinically significant, why wouldn't you look?" he said. "Within a couple of weeks you'll know if Veristrat works in this particular setting."

Beresford noted that the company plans in the near future to purchase a new MALDI instrument to keep up with rising test volumes. The new machine will also be a Bruker, he said, although he said that the company was following developments by other firms in the MALDI space.


Have topics you'd like to see covered in ProteoMonitor? Contact the editor at abonislawski [at] genomeweb [.] com.

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