NEW YORK – Immunogenomics startup Immunis.AI, once called OncoCell MDx, is eyeing the commercial launch of its prostate cancer surveillance laboratory-developed test, which leverages its immune-based liquip biopsy platform, by early 2021, the company said.
The Royal Oak, Michigan-based firm also aims to finalize an independent validation study for the prostate cancer signature assay within the next two months.
Immunis.AI Chief Medical Officer Kirk Wojno explained that the liquid biopsy platform, dubbed "Intelligentia," applies RNAseq and machine learning to develop disease-specific algorithms to identify disease-initiated epigenetic changes using about 8 ml of a patient's blood sample.
Spun out of Harvard University, Immunis.AI is developing subtraction-normalized expression of phagocytes (SNEP) technology that quantifies the RNA expression data from both non-phagocytic CD2+ and phagocytic CD14+ cells.
"When a living cell reacts to something, it ramps up RNA expression of various genes to manage the problem," Wojno explained. "We believe that the cellular immune response, by reacting to early phases of abnormality in the body, gives us the best signal, rather than looking at information dying cells have spilled out as waste product."
"On the phagocytosis part, we're getting data together and having it packaged in an [upcoming] publication and showing that phagocytosis picks up disease signals," added Immunis.AI President and CEO Mark McDonough. He noted that Immunis.AI aims to individualize the technology by reducing background cellular noise while amplifying the signal in CD14+ phagocytes using proprietary methods, and highlighted that the Intelligentia prostate cancer risk score assay has an AUC of .831.
While Immunis.AI's eventual goal is to ensure that its Intelligentia assays are platform-agnostic, Wojno noted that the team initially performed its research and discovery work using whole-genome RNA sequencing technology. However, Immunis.AI aims to establish a clinical relationship with NanoString Technologies and has used the firm's nCounter Flex Analysis system since last fall.
"One of the reasons we were attracted to NanoString was the cost benefit, clinical benefit, but also because of the tool's throughput advantages," McDonough said.
In addition to the prostate cancer active surveillance assay, Immunis.AI is looking into developing pre-biopsy and immune cell-based pan-disease diagnostic tests. Wojno noted that the firm "looked across the spectrum of diseases [where] we thought we could make the biggest health impact," which drove it toward neurological diseases.
The team will initially analyze biomarkers for Alzheimer's disease, coronary artery disease, rheumatoid arthritis, diabetes, and lung cancer. McDonough noted that the group is also considering additional cancers in the pan-disease panel, including breast, colorectal, head and neck, liver, lung, and pancreatic cancer.
"While we look at immune cells, we think that since we do have IP protection on all analytes, we could eventually look at DNA, proteins, and other analytes," he said. "We've since become interested in cystic fibrosis and kidney disease … as we think the proof-of-concept method can be transposed to other cancers and diseases."
According to McDonough, Immunis.AI currently holds 45 issued and more than 110 pending US and international patents related to its Intelligentia technology. The patents include individualized and personalized subtraction kits, as well as methods for disease detection and prognosis.
Immunis.AI is currently partnering with large undisclosed urology groups across the US to accrue prostate cancer blood samples as part of its Safe Active-surveillance For Everyone Longitudinal Yearly (SAFELY) validation study, which the firm anticipates completing within the next couple of months.
"This is the endgame for our first project," Wojno said. "We have data that details high specificity to detect multiple diseases in one blood draw."
Following the completion and subsequent publication of the SAFELY study, Immunis.AI anticipates launching the assay as an LDT for research use only performed at its CLIA-certified, CAP-accredited lab in Royal Oak by the end of 2020 or early 2021.
"When we first launch the test and work with academic centers, it will be an LDT predicated on validation we are doing in the current trial," McDonough said. "However, we will need additional data to get revenue and [convince] payors that our test is valid."
Immunis.AI then expects to offer the prostate cancer pre-biopsy test in 2022, potentially followed by the pan-disease panel in 2024. In contrast to pursuing the LDT path, as with the prostate cancer risk score and pre-biopsy tests, McDonough noted the firm will seek premarket approval from the US Food and Drug Administration for the pan-disease panel.
Despite pushing further into the liquid biopsy space with the anticipated assay launch, Immunis.AI has yet to determine a price for the envisioned prostate cancer risk score test. However, Wojno noted that Immunis.AI will continue to refine the amount of blood needed to run the different immune response assays, as well as expand its bioinformatics side and build out its relationship with commercial partnerships.