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With New Funds, Mitra Biotech Focused on CANscript Clinical Utility Studies, Securing Reimbursement


NEW YORK (GenomeWeb) – Mitra Biotech will use the cash infusion from a recently completed financing round to conduct clinical studies necessary for securing reimbursement for its CANscript platform in the US.

This week, Mitra RxDx (which does business in the US as Mitra Biotech), announced it had raised $40 million in another financing round, bringing the total amount it had raised since its founding in 2010 to $76 million.

The funds will be put toward building the evidence base for CANscript. Toward this end, the company has two clinical utility studies underway and one large clinical validity study slated for publication later this year.

The CANscript platform creates an ex vivo tumor ecosystem that closely resembles how a cancer patient's tumor looks and acts inside the body. The platform can model how different treatments impact factors indicative of tumor response, such as cell proliferation and death. The findings are then evaluated by a machine learning algorithm to calculate a score that corresponds to how likely a patient is to respond to a specific drug or regimen.

Just over a year ago, the company announced it would make its CANscript platform available to oncologists in the US through an early-access program. At the time, the company had indicated that the early-access program would help generate the clinical utility evidence necessary to drive broader adoption of the platform.

Before launching the program, Mitra had also garnered CLIA certification for its Woburn, Massachusetts-based lab. Since then, the company has also garnered CAP accreditation for the Woburn facility, and built a new lab in Bengaluru, India.

Kirk Mundy, senior director of worldwide clinical marketing at Mitra, said that these lab facilities are supporting the privately held company's expanding biopharmaceutical and oncologist customer base. He estimated that Mitra has done 50 projects with more than 15 of the 20 top drugmakers, which are using CANscript to identify targets and gain preclinical insights into their pipeline or products.

While Mitra's biopharmaceutical business has been in operation longer than its clinical testing business, "the clinical testing business is definitely gaining traction," Mundy said, as the company continues to build the evidence underlying CANscript.

In 2015, the company published a clinical validation study in Nature Communications, where researchers used CANscript on samples from patients with head and neck squamous cell cancer and colorectal cancer. Although at this validation stage, CANscript wasn't used to inform treatment strategies for patients in the clinic, it demonstrated 91.7 percent specificity and 100 percent sensitivity in predicting how these patients actually responded to the treatment they received.

Mitra has continued to develop and validate CANscript in other solid tumors and hematologic malignancies, and a clinical validity study involving 1,000 patients is slated for publication later this year. Two other clinical utility studies are also underway, one in India involving more than 30 sites, and another in the US at more than 20 sites.

The company is doing these studies to help facilitate payor reimbursement, which in turn will drive adoption among oncologists who want to use CANscript to personalize treatments for their patients. "Payors want to know if doctors are going to use this," Mundy said. "Because if doctors aren't going to use the results and it doesn't change anybody's behavior, then what's the point?"

He added that the clinical utility studies will also evaluate how patient outcomes are impacted when doctors use CANscript results to inform treatment strategies. "A lot of these are advanced metastatic patients faced with few options and even when there are options they only benefit a minority of patients," Mundy said.

As Mitra is trying to build the evidence to support reimbursement for CANscript, next-generation sequencing-based tumor profiling got a major boost earlier this year after the Centers for Medicare and Medicaid Services issued a national coverage determination after reviewing Foundation Medicine's FoundationOne CDx in parallel with the US Food and Drug Administration. The final NCD provides coverage for FDA-approved NGS cancer tests, for FDA-approved CDx indications to patients with relapsed, refractory, or stage III cancers in addition to stage IV cancers, and allows for repeat testing when a patient has a new primary diagnosis.

While the NCD promises to drive adoption of NGS in precision oncology, some oncologists have been vocal about the fact that NGS tumor profiling ends up helping a minority of their patients. An oft-cited study, published in 2015 by Funda Meric-Bernstam and colleagues from MD Anderson Cancer Center, reported that out of 2,000 patients who received genomic testing at the facility, 39 percent had an actionable mutation, but only 116 patients received a genotype-matched drug, and even fewer got on a genotype-guided clinical trial.

Even when NGS identifies an actionable biomarker and drug, oncologists often find that their patients have difficulty getting the drug, or don't meet eligibility criteria to get on the trial, or are too sick and die before they can get access to genomically matched therapy. Moreover, the only randomized controlled study investigating the benefits of NGS-guided cancer treatment, SHIVA, has raised more questions about the extent to which genomically informed precision oncology approaches are improving patient outcomes. 

Mitra is hoping to show through its clinical utility studies that CANscript can do better in terms of getting patients quickly on cancer treatments that will improve their outcomes. Parker Cassidy, Mitra's chief commercial officer, has previously said that CANscript can deliver actionable results for almost 75 percent of patient samples that the company receives.

The ongoing clinical utility study in the US, entitled CANscript Clinical Outcomes in a Real-World Setting-2 (ANCERS-2), will involve 800 patients with advanced solid cancers whose doctors order CANscript and inform therapy based on the results. The patients will then be followed to evaluate how they responded to treatment. After stopping treatment, patients will continue to be followed for up to two years to gauge survival. The clinical utility study in India (ANCERS) is similarly designed.

Mitra is also conducting economic modeling to demonstrate that CANScript can save the healthcare system money by helping patients avoid ineffective or more toxic treatments.

"Payors love paying for what works but they'll want to know what's the impact on their system or on their group of patients," Mundy said.

The company's strategy is to first secure coverage and payment from private payors and then tackle Medicare. The Protecting Access to Medicare Act, signed into law in 2014, established a market-based pricing system for lab tests where Medicare payment for a test is calculated based on the weighted median of private payor rates."Given PAMA, it's wise to establish your commercial payment track record first, before you go for Medicare," Mundy said.