Royal Oak, Mich.-based liquid biopsy startup Oncocell MDx Inc. reeled in $22.2 million in a series B financing led by Savitr Capital, with participation from existing investors. The company, which has raised a total of $30 million to date, plans to use the proceeds to support ongoing development of its pan-disease immunogenomics platform and commercialization of its novel noninvasive blood-based tests.

Founded in 2012 as a spinout of Harvard Medical School with technologies created there by Oncocell founder Amin Kassis, the company hopes to launch its first product in 2020 – a blood test to detect and grade aggressive prostate cancer. The offering will initially launch as a lab-developed test for research-use only, performed at Oncocell's CLIA-certified, CAP-accredited lab in Royal Oak, with the possibility of adding other facilities across the country "to optimize turnaround for physicians," Mark McDonough, Oncocell's president and CEO, told BioWorld.

Broad potential

Oncocell has already run discovery studies on the prostate test and is now in the process of validation and verification studies, McDonough said, adding that the company's leadership is experienced in navigating the FDA pathway but has not set a timetable for regulatory submission.

McDonough said that what sets Oncocell apart from other liquid biopsy companies is the platform's potential in both pan-disease and individual assays and how it approaches disease. "Oncocell's platform assesses the incremental effort expended by the immune system to contain the disease, measured by specific gene expression signatures, to identify and characterize it, at the time the tumor evades the defense system," he explained. "Leveraging the internal amplification structure inherent in the immune system allows earlier signal detection than other techniques such as looking for circulating free DNA from apoptotic circulating tumor cells, which are more likely to be present in more advanced disease."

The platform uses an algorithm to examine changes in gene expression of two cell types associated with prostate cancer, phagocytic CD14 and nonphagocytic CD2 cells, and filter out unwanted noise and better home in on the disease target. "The initial prostate cancer test addresses a significant need to improve patient selection for active surveillance and to provide a noninvasive method for annual monitoring," McDonough said. "The company's goal is to help reduce overtreatment of indolent disease through risk stratification and also help identify patients who may need treatment right away."

Oncocell described a feasibility study to assess the blood-based immunogenomics RNA expression assay's usefulness in prognosis of prostate cancer at the American Association for Cancer Research meeting in Atlanta earlier this year. The company plans to submit several papers on the prostate test to academic journals over the next six months, beginning with one submitted this month. The papers will address topics such as how purified CD2 and CD14 immune cells respond to different disease stimuli and how prostate cancer signatures can be discovered and validated using artificial intelligence and machine learning.

Other tests in the pipeline

McDonough said the company will be exploring additional financing in the coming months to bring the prostate test to market, advance R&D and subsidize clinical trials necessary to secure reimbursement and regulatory approval.

In addition to the prostate cancer test, Oncocell has some initial data in cancers of the colon, lung, head and neck. The company is also looking beyond cancer, to applications in cardiovascular, infectious and neurodegenerative disease, as well as immune- and kidney-related diseases.

Oncocell is one in a growing field of companies eyeing the liquid biopsy market, which Zion Market Research predicts will hit $12 billion by 2025. Last week, Laboratory for Advanced Medicine Inc. won an FDA breakthrough device designation for its Ivygene DX liver cancer test, which analyzes the DNA methylation pattern of cell-free DNA to detect the presence of hepatocellular cancer as early as stage 1. Meanwhile, Stockholm-based Elypta AB is planning a multicenter study to evaluate the ability of its liquid biopsy platform to detect early recurrence of renal cell carcinoma following surgery. Other contenders include Pcl Inc., of Seoul, South Korea, and U.K.-based Angle plc.

McDonough, who joined Oncocell in April from Phosphorus Diagnostics LLC, a genomic health company, has been busy building an executive team to take Oncocell forward. This summer, he named Christopher Thibodeau and Kirk Wojno to serve as chief operating officer (COO) and chief medical officer, respectively. Thibodeau was most recently COO of MDxhealth Inc. Wojno was previously head of urologic pathology at the University of Michigan.

He welcomes the growing competition. "Oncocell believes we are at the very early days of a huge swing toward liquid biopsy and noninvasive blood testing – it's an estimated $30-plus billion market," McDonough said. "There is room for multiple players."

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