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OncoCyte Highlights New Data for DetermaRx, IO Tests; Discusses Breast Cancer CDx Possibilities

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NEW YORK – Despite the COVID-19 pandemic, Oncocyte has been making progress in its efforts to ramp up clinical testing and pursue new research opportunities, company executives said this week.

Specifically, the company has been engaged in health economic research to support commercialization of its DetermaRx assay, and has generated new data on the predictive nature of its more recently acquired research-use DetermIO test.

Initially called the Razor Genomic test when Oncocyte acquired Razor last year, DetermaRx is Oncocyte's first commercialassay. It relies on gene expression analysis of tumor tissue to differentiate patients at high risk for lung cancer recurrence who may benefit from adjuvant chemotherapy post-surgery, from those at a lower risk who might avoid it.

Oncocyte received a final local coverage determination from Medicare contractor Palmetto for the Rx assay last quarter, making it the first product to begin generating clinical testing revenue for the company.

In a call discussing the company's first quarter financial results this week, CEO Ron Andrews said a planned live presentation on a health economic study of DetermaRx at this year's American Thoracic Society annual meeting was cancelled due to the ongoing pandemic but the study abstract was published as part of a virtual release for the event last month.

According to Andrews, the study analyzed long-term data from a cohort of 195 patients, showing that one in three untreated patients identified as high risk through testing using the company's assay experienced a recurrence of cancer, and 70 percent had this recurrence within two years of surgery. In contrast, 96 percent of patients identified as low risk did not recur.

Andrews argued that the data not only reiterate the test's ability to detect high-risk disease that requires further treatment, but also illustrate potential value for DetermaRx both in helping to funnel patients who need it to treatment and in reducing unnecessary surveillance of low-risk individuals.

"These low-risk patients were followed closely by frequent radiologic scans, which are associated with patient stress and can be inefficient, costly uses of health care resources. Our data show that limiting the follow-up of those low-risk patients to annual surveillance scans would have reduced overall scan frequency by 50 percent while having very little impact on the detection of cancer recurrence," he said.

Oncocyte Senior Vice President of Commercial Padma Sundar reiterated this takeaway and argued the study "will be very useful not just for patients but also for commercial payers as we approach them to cover this test."

In its own clinical operations since launching the test, Andrews said the firm has, to date, identified 17 high-risk patients "who changed their treatment course with the addition of chemotherapy."

DetermaIO

DetermaIO, meanwhile, is a test that Oncocyte brought on through its acquisition of Insight Genetics this January. Formerly called the Immune Modulation, or IM Score, it is also a gene expression test, performed on tissue samples, generating molecular signals from the immune microenvironment to identify individuals that are more or less likely to respond to checkpoint immune therapies.

Oncocyte believes DetermaIO could be a better predictor of immunotherapy response than PD-L1 biomarker assays and tumor mutational burden, or TMB.

The company has previously highlighted data developed and presented by Insight showing that the test has shown a strong association with immunotherapy response in lung cancer patients, but Andrews said this week that the company now expects to share new data on the test's potential utility in breast cancer, in an abstract being released as part of the virtual annual meeting of the American Society of Clinical Oncology.

According to Andrews, the data, generated in collaboration with MD Anderson, demonstrate the performance of the test in predicting response in triple-negative breast cancer (TNBC), which is considered the most deadly and hardest to treat subtype of these tumors.

Moving forward, Oncocyte has said it aims to extend the data for DetermaIO into larger, more diverse populations across multiple solid tumors.

Speaking last month, Andrews had said discussions with partners for additional drug studies using DetermaIO were somewhat stymied by the COVID-19 pandemic. But this week he said that the company has rebounded from that, with new discussions emerging around potential pharma partnerships.

TNBCtype

Andrews also mentioned a separate breast cancer assay that Insight developed before being acquired by Oncocyte, called TNBCtype. Oncocyte has not commented much on this product previously but discussed it in more depth during the call this week.

TNBCtype, launched as an LDT by Insight in 2018, is a 101-gene next-generation RNA sequencing assay that uses a proprietary algorithm to classify patients into five subtypes associated with responses to different types of therapeutics, including immunotherapy, targeted therapies, and cytotoxic chemotherapy.

One way the company sees this product contributing to its business is in pharma research services, a segment it created and is participating in for the first time with the Insight Genetics acquisition.

"While there have been great strides in improving outcomes for patients with breast cancer … [TNBC continues to have] lower five-year survival rates and less-effective treatment options. Because of this, there's a significant amount of pharma focus, with over 100 ongoing clinical trials and additional discovery-phase programs," Andrews said.

Along these lines, researchers published a study late last month in PLoS ONE on the usefulness of the assay in identifying cell lines that can aid in efforts to develop new treatments for TNBC.

In the study, researchers established tumor xenografts from 17 TNBC cell lines and analyzed them using the initial TNBCtype assay, as well as a new revised 101-gene algorithm called TNBCtype-IM. According to the company six of the cell lines maintained consistent subtype classification between in vitro and in vivo tumor xenograft analyses using the updated algorithm, "suggesting they may be the optimal cell lines for use in subtype-specific TNBC drug development and translational research."

The company is not just focused on early-stage studies though, and Andrews suggested on the call that Oncocyte believes the assay also has potential as a companion diagnostic.

"We believe [this] may be an important classifier to help patients with TNBC select therapy and also more broadly as the potential companion diagnostic beyond immune therapy to appropriately target proprietary therapeutics in development for TNBC at various biopharmaceutical companies," he said during the call.

"We believe that TNBCtype may eventually provide an important role in identifying the best clinical treatment plan for these patients across multiple therapeutic platforms," he added.

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