NEW YORK (GenomeWeb) – With the launch last year of its PCR-based GeneStrat liquid biopsy test for non-small cell lung cancer and the release of a next-generation sequencing test planned for later this year, Biodesix continues to expand its offerings with the aim of addressing additional points in the NSCLC care pathway.
According Paul Beresford, the company's chief business officer, the move into genetic testing has also helped drive sales of Biodesix's flagship product, Veristrat, a proteomic test for assessing a patient's prognosis and predicting response to drug treatment.
Proteomic-based tests remain for many clinicians a somewhat exotic option. On other hand, doctors are often more familiar and comfortable with genetic tests, and so Biodesix's GeneStrat, which uses BioRad's droplet digital PCR to identify clinically actionable mutations in EGFR, KRAS, ALK, and BRAF in free tumor nucleic acid, has to an extent helped the company get its foot in the door with oncologists, Beresford said.
"When folks are familiar with gene-based testing, it is an entrée [for Biodesix] to those practices that have traditionally not been all that interested in Veristrat," he said. "Them getting familiar with the company and understanding that we have a number of tools to help them make [treatment] decisions then gives us an opportunity to introduce Veristrat."
Beresford said that roughly 65 percent of GeneStrat orders are accompanied by a Veristrat order, noting that Biodesix has seen an increase in Veristrat sales since launching Genestrat in May of 2015. He did not provide the number of GeneStrat tests the company has sold, but said that it had "exceeded expectations," adding that "we have hit our forecast [for GeneStrat sales] every month."
"Enabling oncologists to make treatment decisions sooner is key and GeneStrat with reflex to VeriStrat provides clinically useful information on the driver mutations and proteomic prognostic status," he said
Earlier this month, Biodesix added a test for EML4-ALK fusions to the GeneStrat panel.
Between GeneStrat and Veristrat, the company has two products useful in diagnosis and prognosis, which "accelerates the ability of the [clinician] to get patients into the standard care and treatment paradigms," Beresford said. With the launch of an NGS-based test in the second or third quarter of this year, Biodesix aims to add a product targeting patients who have moved beyond standard of care.
Developed through a partnership with UK-based genomics firm Inivata, the NGS-panel will look at 35 genes with the goal of identifying potential therapies for patients who have progressed beyond standard treatment regimes, Beresford said.
He noted that while NGS-based tests are in many cases being promoted for use in front-line settings, Biodesix believes they could prove more useful in later-stage disease.
"We feel that probably about 1 percent to 2 percent of that [NGS] information is relevant for the patient going into standard of care," he said. "If [for instance] you are looking at 100, 200 somatic mutations, most of that information will really sit on the shelf until the late stage when the patient is looking for various options in that triage setting once they have gone through standard of care."
And, by that time, the tumor's genetic profile has likely changed in response to treatment and progression of disease, Beresford noted, potentially limiting the relevance of the data collected prior to the beginning of treatment.
With those considerations in mind, Biodesix plans to offer its NGS-panel "in that triage setting where a lot of these mutations can be queried to decide what are the options for this patient's treatment," he said. "Looking, for instance, at clinical trials or at therapies that are approved [for diseases other than NSCLC], but that may be an option based on [a patient's] mutations."
In addition to fleshing out its genomic offerings, the company continues its work promoting and gathering evidence in support of Veristrat. In a recent paper in the Journal of Thoracic Oncology, researchers used the test to enrich for patients with advanced NSCLC with borderline performance status (performance status 2, or PS2), selecting those who returned a Veristrat test result of "good" for randomized treatment with either Genentech's EGFR-inhibitor Tarceva (erlotinib) alone or erlotinib with chemotherapy.
The results of this study did not entirely bolster the case for Veristrat, however, as it found that this population of Veristrat "good" patients responded better when treated with both erlotinib and chemotherapy as opposed to erlotinib alone, and so, as the authors noted, the trial "provided no evidence to suggest that conventional doublet chemotherapy should not remain the standard of care even in highly selected patients with PS2."
Biodesix is also continuing work on Veristrat through its collaboration with drugmaker Aveo, under which it is co-developing and commercializing Veristrat as a companion test to predict best responders to Aveo's ficlatuzumab, a hepatocyte growth factor inhibitor.
Under the terms of the agreement, Biodesix will fund the first $15 million of the drug development effort with the expenses thereafter split evenly between the two firms. The two will split any profits from commercialization of the drug. Additionally, Biodesix is solely responsible for all development of Veristrat, including taking the test through US Food and Drug Administration clearance or approval, and the company will retain all revenues from sales of the test.
The companies are currently in Phase II clinical trials studying the drug-diagnostic combination and are actively recruiting patients at multiple sites internationally, Beresford said. He added that he expects a Phase III trial would begin in 12 to 18 months, and once that trial is completed the company will have the data needed to take a test based on the same platform as Veristrat through the FDA.
Biodesix has also begun work on developing proteomic tests for identifying likely responders to checkpoint inhibitors. In November, it presented data on a new test for determining melanoma patients who are likely good responders to Bristol-Myers Squibb's programmed death 1 (PD-1) checkpoint inhibitor nivolumab (Opdivo).
Since then, the company has begun working with several large pharma firms that have clinical trials ongoing for checkpoint inhibitors in lung cancer, Beresford said.
To support these activities, Biodesix raised $8.6 million in promissory notes convertible to equity securities in October with plans to raise up to $20 million total. In June, the firm raised $11 million in a private follow-on financing, and in January 2015 it closed a $27 million Series E financing round.