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Oncocyte Details New Expansions Plans With Growing Portfolio of Acquired Tests

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NEW YORK – Diagnostics firm Oncocyte is anticipating a significant expansion of its clinical and research-use testing footprint this year following yet another acquisition — the company's third in less than two years.

The firm said in February that it had agreed to acquire German diagnostics firm Chronix Biomedical with the deal superseding a previously announced collaboration between the companies.

The merger, which is expected to close by the end of April, brings Chronix's cancer immunotherapy monitoring test, TheraSure-CNI Monitor into Oncocyte's portfolio, which currently includes the company's first clinically available test, DetermaRx, and the DetermaIO assay, which is slated for a shift from research use to the clinic by the end of this year.

During a call with investors this week discussing the firm's 2020 fourth quarter financial results Oncocyte President and CEO Ron Andrews said that the Chronix CNI test — which will be rebranded DetermaCNI — is now also slated for launch by the end of this year, initially for research and pharma use only.

Although the discovery and development of immunotherapy biomarkers is advancing rapidly across the diagnostics industry, Andrews said Oncocyte believes that DetermaIO, which the firm picked up in its acquisition of Insight Genetics last year, could provide the company with a leadership position in what he estimated is an approximately $3 billion market.

The tissue-based test analyzes gene expression samples from biopsies or surgical resection, applying an algorithm to weigh signals related to immune cell activity and tumor immunogenicity in order to identify cancer patients likely to respond to immune checkpoint inhibitors.

The primary goal is to capture patients who may respond to treatment but are missed by existing biomarkers like PD-L1 or tumor mutational burden, but the company has also collected early data that suggests the assay could also potentially inform the use of combined treatment with immune checkpoint inhibitors and targeted therapy or chemotherapy.

During the company's earnings call this week Andrews said that Oncocyte will present at scientific meetings and publish new data in the peer-reviewed literature this year from investigations of DetermaIO across a range of tumor types, including lung, breast, and bladder cancer.

He added that the firm has also successfully completed its study with the cancer research center Fondazione Michelangelo in Milan in which researchers evaluated DetermaIO as a predictor of response to the neoadjuvant checkpoint inhibitor atezoliuzumab (Roche/Genentech's Tecentriq) in triple-negative breast cancer.

The company plans to share new data at the upcoming virtual annual meeting of the American Association for Cancer Research focused on bladder cancer, which Andrews said is also from a retrospective analysis of an atezolizumab clinical study.

The Michelangelo study was investigator-sponsored and, as such, does not represent an official companion diagnostic collaboration with Genentech. Nevertheless, Andrews suggested that successful results could be a first step to expanding the drug's indications.

Onococyte is also planning to make available a second treatment predictive test to run alongside DetermaIO when it launches later this year. Marketed as DetermaTx, the firm has said in investor presentations that this assay will be for guiding the use of molecularly targeted therapies using an externally developed, FDA-approved kit that Oncocyte will validate in its CLIA lab.

During the call this week, Andrews said that discussions are still ongoing as to what off-the-shelf sequencing panel this will be.

Next in line, now that the company has initiated its deal with Chronix, is what Oncocyte hopes will be its entrée into the emerging blood-based therapy monitoring and disease recurrence detection market. The planned DetermaCNI assay measures changes in copy number variation present in a cancer patients' cell-free DNA, something Chronix has previously shown can indicate response or lack thereof to cancer immunotherapy.

Unlike some technologies being advanced for monitoring and residual disease detection, the CNI test does not require upfront tumor tissue sequencing.

"Our plan is to … launch this as a pharma service in Q2, from our new molecular center [initially] for the European market. Then after tech transfer to our US facilities, we plan to launch the test for pharma use in domestic immune therapy clinical trials in Q4 of 2021," Andrews said this week.

Clinical translation of the assay will hinge on collecting persuasive validation data — either for specific drug- or cancer-type applications, or potentially across the immunotherapy landscape. In investor presentations, Oncocyte has described the existing evidence base for the Chronix CNI assay as including studies of several cancer types. However, these have included only about 365 patients thus far in total.

The company's main publication on immunotherapy was in 2017 in Clinical Cancer Research, where investigators calculated an overall prediction accuracy of 83 percent and a positive predictive value 92 percent for their CNI algorithm when analyzed before the second cycle of therapy. When scores were extended to before the third cycle as well, the test reached 100 percent positive prediction, anticipating treatment failure for all 13 patients in the cohort whose tumors progressed.

Other studies in recent years by Chronix investigators have focused on analyzing the prognostic potential of the CNI algorithm for pancreatic and head and neck cancers.

The firm will also likely face competition, considering that a number of different platforms are being advanced to detect cancer signals in blood, either via specific mutations, copy number analysis, or epigenetic signals like methylation and DNA fragmentation.

Companies including Inivata, Lexent Bio (now a part of Foundation Medicine), and Guardant Health have also collected their own data supporting potential in immunotherapy or other drug response monitoring.

If clinically implemented, Oncocyte's CNI test would, based on the firm's existing immunotherapy data, need to be performed multiple times. During the call this week, Andrews said that the company has done market research on what the "pricing tolerance" would be in this situation for payors to cover such a technology.

"If you look at other models of this … we’re thinking that the total process has to stay within $3,000 and $4,000 across two to three cycles, [so] we’re thinking about $1,000 per cycle for us … to try to deliver it for around $3,000 with three results."

Finally, Andrews also provided some new detail on plans for a test Oncocyte has dubbed DetermaMx — also a blood-based assay but designed for minimal residual disease detection rather than drug response monitoring — which he said the firm plans to offer as a disseminated kit product, which would require going through FDA review for clinical use.

The company expects to launch DetermaMx, which builds on PCR IP acquired from Chronix, for research use by the end of 2022.

"We believe Mx … is best suited for democratization and … [that a] kitted product that can go into an installed base of a digital PCR or a PCR platform will allow us to create an ability to … bring it closer to the patient," Andrews said.

"We have opportunities with certain partners that we have worked with through our years that have IP around ways to make PCR more sensitive and to allow us to use surrogate markers in blood that would identify a recurring tumor … and we suspect that by this time next year, we’ll be able to talk a lot more about the data … [but] we have to be a little bit guarded because obviously, some of this will require patenting," he added.

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