Cancer Genetics, Inc., a leader in enabling precision medicine for oncology through molecular markers and diagnostics, has announced the expansion of its immuno-oncology (IO) panel, Complete::IO™, to include five new IO markers. This brings the total number of markers it simultaneously detects to 27, making Complete::IO™ the most comprehensive flow-cytometry-based biomarker panel in the industry, with a 24-hour turn around time.
Since its launch in April 2017, Complete::IO has quickly gained commercial traction and has already been included in notable immunotherapy trials including studies of CAR-T therapies and checkpoint inhibitors. Complete::IO™ is a multi-marker panel enabling comprehensive characterization of the immune repertoire of cancer patients, including circulating immune cell populations and the tumor microenvironment. It plays a unique role in identifying ideal patient populations for specific IO therapies and addresses the unmet need to monitor and stratify patient populations during clinical trials. The panel also assures that patients are monitored for safety and toxicity throughout the trial. The increased number of markers allows for the identification of rare and challenging subsets of immune cells.
Simultaneously Assesses 27 Unique Immune Markers
Besides the commonly studied subsets, central memory, effector, effector memory cells, naïve CD4+ and CD8+ T cells, T-regs, B-regs, NK, and plasmacytoid dendritic cells, Complete::IO™ is now able to power highly accurate immunophenotyping and the measurement of the frequency of myeloid-derived suppressor cells (MDSCs), as well as those that express PD-1, PD-L1, or PD-L2.
The presence and frequency of MDSCs, which inhibit anti-tumor immune response, in the blood of cancer patients, might represent a novel and accessible biomarker to monitor clinical outcome and response to therapy. In addition, targeting MDSCs to increase the efficacy of immunotherapeutics appears to be a clinically promising strategy, and is being actively evaluated in clinical trials. According to industry reports, there are over 2,500 active clinical trials globally related to IO therapies.
“Complete::IO™ analyzes dynamic changes across immune cell populations, and with this latest expansion, includes additional biomarkers that have emerged as important to immuno-oncology,” said Rita Shaknovich, Chief Medical Officer of CGI. “Complete::IO has the unique ability to determine precise details of anti-tumor immunity for each patient. Complete::IO™ effectively enables informed therapeutic decisions and assessment of potential toxicities of IO therapies in both hematological malignancies and solid tumors.”
Determines Optimal IO Therapies and Tracks Response and Resistance Mechanisms
The addition of PD-1, PD-L1 and PD-L2 to the panel is in concert with recent studies associating the expression of these markers by tumor cells and/or immune cells in the tumor microenvironment with clinical efficacy of IO therapies. Flow cytometry as compared to other methods has the advantage of simultaneously measuring the expression of PD-1 and its ligands PD-L1 and PD-L2 in malignant cells and various types of immune cells. This provides a more comprehensive understanding of PD-1/ligand interactions between tumor cells and the immune environment.
“Cancer therapy has been revolutionized by the development of IO therapies, including checkpoint inhibitors and others. However, response rates are variable and the development of more robust assays is imperative. To our knowledge, Complete::IO™ is one of the most comprehensive solutions for drug companies and physicians seeking to optimize their novel treatment options, including mono- and combination therapies” said Panna Sharma, CEO and President of CGI. “The pharmaceutical industry has already recognized the merits of applying this solution to biomarker studies as part of the clinical development of novel cancer therapies, both as a valuable tool for patient selection and for monitoring. We expect it to become an integral component of additional IO studies to help patients gain maximum benefit from immunotherapy options in the treatment of cancer. The expansion of our Complete::IO™ panel is key to our continued strategy to move beyond genomics to integrate information about immune marker status, the tumor microenvironment and cell surface biomarker expression in order to predict patient responses.”
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