NEW YORK – Chinese oncology genomics firm Burning Rock Biotech shared new details this week on a previously announced assay it is developing for cancer monitoring and minimal residual disease detection, as well as its final validation and upcoming launch plans for a multi-cancer early detection test.
During a call discussing the firm's Q2 financial results, CEO Yusheng Han said that the firm has named its MRD product BR Prophet, and is currently validating it in lung cancer, with studies in other cancer types to follow.
Meanwhile, data supporting the firm's epigenetic early detection technology, BR Predict, continues to grow, most notably with a publication this June in Nature Biotechnology. Han said that on the back of this, as well as recent conference presentations, Burning Rock has already entered the contracting stage with six hospitals, and has tested more than 2,000 samples as part of its early-access program.
Shannon Chuai, Burning Rock's chief operating officer, said that these 2,000 EAP samples are providing an important platform for assessment of the test's performance in its intended use population. But the company also intends to conduct a formal prospective study to fully define sensitivity and specificity and assess clinical utility of the test.
"The EAP actually gave us a clearer estimate on the performance among the intent-to-use population, which is helping us with the design of the prospective interventional study down the road as well as our ongoing communications with regulatory [agencies]," Chuai said.
"One thing that's quite promising," she added, "is that the specificity we demonstrated in the case-control Thunder study is now holding very well in the real world, so this gives us a lot of confidence going forward."
Unlike some other companies in the cancer screening or early detection space, Burning Rock is taking an iterative approach, launching a narrower product first as it works to validate larger and larger assay panels for future commercialization.
The firm has reported various data at scientific meetings on the six-cancer version of its Predict test, most notably from its primary validation study, called Thunder, and Chuai said the company now intends to make that assay commercially available in early 2022.
In the new publication in Nature Biotechnology this June, company researchers and clinical collaborators reported technical performance data for the company's core machine learning, DNA methylation-based approach. Investigators wrote that Burning Rock's technology could detect tumor-derived signals at dilution factors as low as 1 in 10,000.
In 308 patients with surgically resectable lung cancer and 261 age- and sex-matched non-cancer controls, the assay detected between 52 percent 81 percent of the cancers, depending on stage, with a specificity of 96 percent.
Chuai stressed that considering the lengthy scientific publication process, this data reflects an older version of the Predict assay and model than what is now on track for the market next year. Nevertheless, she said, the data helps "endorse the novelty and utility" of the firm's technology.
Moving forward, Burning Rock has a developed two expanded follow-on products: a nine-cancer and a 22-cancer detection panel. To validate these, the company has two multisite prospective case-control studies ongoing, called Predict and Prescient. Each will recruit more than 10,000 participants.
"Predict is expected to have the first readout by the end of 2022 and Prescient will have data readouts [in] 2024," Chuai said.
Han added that the company is confident in its ability to command the emerging multi-cancer early detection market in China, despite competitors pursuing similar epigenetic technologies.
"In terms of multi-cancer early detection, if you look at the data, [we believe we have] the best data in China," he said. "And if you look at the trials … the only two trials for multi-cancer early detection that have passed the [human genome regulation requirements] … all come from Burning Rock, so from my point of view, we don't have serious competitors in [this] market."
Burning Rock has released relatively less information thus-far on its plans for MRD, or minimal residual disease testing, despite its pledge that an MRD test will join it's six-cancer Predict assay on the market next year. But on the call this week, Chuai filled in the blanks, describing the product as a tumor-informed blood-based assay, which has been dubbed BR Prophet.
Interestingly, although the company has an established epigenetic technology developed for its early detection products, it did not choose to apply that strategy to MRD, as some companies, like Guardant Health have done. Instead, the firm is mirroring companies like Natera, Inivata, and ArcherDx, which develop patient-specific mutation panels based on tumor tissue sequencing data.
Chuai said that the target limit of detection for the Prophet test is 0.004 percent, and Burning Rock expects to report clinical validation data supporting its use in lung cancer in the first half of 2022. In parallel, the company is also initiating studies in other tumor types, including colon and esophageal cancer.
According to Chuai, the market for residual disease detection in early-stage solid tumors is burgeoning in China. For example, she said, blood-based MRD testing was endorsed earlier this year by a Chinese lung cancer commission to help predict risk for relapse for early-stage non-small cell lung cancer patients. "This same consensus also made clear that methods used for MRD testing should be able to reach an LOD as low as 0.02 percent, which is five times higher than what we are aiming for," she said.
"Most NGS panel solutions for liquid biopsy therapy selection … have a LOD only around 0.1 percent to 0.5 percent, including ours," Chuai added. "This is not enough in MRD detection, so you can imagine that this will be a new line of work in terms of technology [development] for us."