By Tony Fong
NEW YORK (GenomeWeb News) – As Biodesix continues clinical validation and commercialization of its test to predict patient response to therapies for non-small cell lung cancer, it is looking to forge pharmaceutical partnerships to increase adoption of the test.
The company is in the midst of conducting a trial in Italy to determine whether the test can determine which NSCLC patients may respond best to treatment with EGFR inhibitors such as erlotinib versus other therapies such as docetaxel. It hopes to release data from the trial at the annual meeting of the American Society of Clinical Oncology in 2012.
While that is happening, the Broomfield, Colo.-based firm is increasing efforts targeting drug firms as part of its strategy to build up commercialization of the proteomic test, Biodesix's vice president of business development and strategic marketing, Paul Beresford, told GenomeWeb Daily News during the JP Morgan Healthcare Conference last week.
"We're really trying to develop new business models where we focus not only on the diagnostic, but also potentially collaborating … with pharma companies to work around clinical trials," Beresford said. "So we've been really focused on companies that have distressed assets that have a tough time getting to market."
Biodesix has also looked to companies "that have been having challenges in very crowded market areas and want to differentiate their drug based on a diagnostic test," and has been in discussions with drug firms that have been pairing EGFR inhibitors with angiogenesis inhibitors.
In November, the company presented results from a Phase II trial of first line erlotinib combined with sorafenib in patients with advanced non-small cell lung cancer, conducted to assess VeriStrat's ability to predict patient outcome with a combination regimen of the two drugs.
VeriStrat analysis classified 33 of 49 patients as likely to have "good" outcomes and 15 patients likely to have "poor" outcomes, and the company concluded that VeriStrat "good" patients had "significant improvement in overall survival compared to VeriStrat 'poor' patients."
The median overall survival rate for VeriStrat "good" patients was 13.7 months, compared to 5.6 months to VeriStrat "poor" patients, the company said, adding that researchers concluded that the proteomic test, VeriStrat, may identify a subset of patients that derive significant clinical benefit from first- line treatment of advanced NSCLC with dual targeted therapies
Lastly, Biodesix is eyeing "new classifier developments outside of VeriStrat" or drugs that "don't fall into the mechanism of action that VeriStrat has," he said, though the focus remains on oncology.
During the past two years, the company has had 16 meetings with various drug firms and is in the process of signing approximately 20 deals around VeriStrat. At the end of 2010, Biodesix signed five such deals, Beresford said, though it has not disclosed the identity of its pharma partners.
In total VeriStrat is being developed as a companion diagnostic for about six small- and large-molecule compounds, Beresford said.
Last fall, the Broomfield, Colo.-based company announced that it had raised $7.1 million in a Series C round to further develop VeriStrat, bringing the total amount raised during the past four years to more than $30 million.
VeriStrat is based on Biodesix's ProTS platform, which combines MALDI mass spectrometry with a set of algorithms. While the focus has thus far been on non-small cell lung cancer, Biodesix is developing the serum-based test for other indications. According to Beresford, VeriStrat is applicable across all epithelial tumors, and the firm is researching its effectiveness in the areas of head-and-neck cancer and colorectal cancer. So far, its studies indicate that the test is able to predict response to EGFR inhibitors for these other cancers as well as it does for NSCLC.
While its research into colorectal cancer indicates that the results achieved with VeriStrat are comparable to KRAS mutation tests, Biodesix does not plan to actively pursue that path because there is already a well-established market for KRAS testing in colorectal cancer. "It would be a tough head-to-head competition," Beresford said.
In addition, Biodesix has begun trials for VeriStrat's ability to predict response to therapies involving breast cancer, pancreatic cancer, and liver cancer. "And we expect we'll see similar data across those trials, as well," he added.
Within the next two years, the firm plans to begin moving its ProTS platform beyond the cancer space to other diseases
In addition to developing the test itself, during the past year, VeriStrat has been developing technology to simplify the testing process and getting samples to its CLIA-accredited lab. Serum samples for VeriStrat were originally shipped on dry ice. That mechanism has been converted to a serum card in which a blood draw is spun out and the serum is spotted on the card, and then shipped to Biodesix's CLIA-accredited lab.
"That has been a big help from just a logistics standpoint and not having to ship dry ice to the clinical oncology sites," Beresford said.
Around the middle of this year, the company expects to launch the next iteration, a blood card in which a pinprick of blood is dropped on the card, the red blood cells are "held back in the matrix," and serum is extracted from the leading edge of the diffused sample.
"So it's going to be even more [likely that] you don't need to do a centrifugation of the sample before actually sending it in to Biodesix," Beresford said.
VeriStrat is approved for use as a laboratory-developed test in all 50 states in the US and Biodesix plans to pursue clearance from the US Food and Drug Administration for the test. However, it won't do so until the agency provides greater clarity on its plans to regulate LDTs, he noted.
For now, while Biodesix will accept samples from Europe, Biodesix does not plan to make VeriStrat widely available there in order to concentrate on the US market.
Beresford declined to disclose revenue figures for VeriStrat, but said that in the last quarter of 2010, the company's laboratory received a record number of tests. Biodesix is still in the early adoption stage of the test, he said, and the biggest challenge has been getting clinicians to use it.
On that front, the company is conducting trials "looking at how we're changing the medical practice of doctors based on our test," Beresford said. Biodesix is also working with the National Comprehensive Cancer Network in order to get the test included in NCCN's guidelines. If the company gets to break-even, it plans to hire additional sales staff to market the test to the oncology community, as well.
The company also is in the midst of applying to the Centers for Medicare and Medicaid Services for reimbursement for VeriStrat. "This year is really the year of appeals with Medicare," Beresford said, adding that the test is being reimbursed at about 20 percent to 30 percent from private payors.