Complete::IO™ – CGI’s New Panel to Advance Immuno-Oncology and Precision Therapy
As you may have seen, Cancer Genetics, Inc. (CGI; Nasdaq: CGIX) issued a press release earlier this week announcing our Complete::IO™ flow cytometry panel. This unique and comprehensive panel enables informed therapeutic decisions and assessment of potential toxicities for novel immuno-oncology (IO) therapies across both blood cancers and solid tumors.
Immune-modulating agents, both non-specific (bacillus Calmette-Guerin (BCG) and levamisole) and specific (various monoclonal antibodies, cytokines, and vaccines), have been around for decades, but have offered only limited use and provided limited success. Contrast these drugs with the exponential gains in IO therapies in recent years through the development of immune checkpoint inhibitors and other paradigm changing drugs like nivolumab (Opdivo®) and pembrolizumab (Keytruda®).
Newly understood IO pathways, along with more targeted IO drugs, have demonstrated significant advances against a wider range of cancers and have gained significant attention from the oncology community. Already approved by the U.S. Food and Drug Administration (FDA) for a few cancers, including melanoma, non-small cell lung cancer (NSCLC), and bladder cancer, immune checkpoint inhibitors also appear to have significant antitumor activity in multiple other tumor types, as well. The demand for biomarkers for identification of a suitable patient population for this type of therapy is now an urgent need in our industry. While specific biomarker assays have been developed for these checkpoint inhibitors based on their respective epitopes, such as PD-L1 and PD-1, the available studies suggested the clinical utility of these biomarker assays is for response stratification and not patient selection. Further improvement in assay development is needed to identify ideal patient populations for such therapies. In addition, novel complex clinical trial protocols and medical use guidelines based on individual’s specific genomic profiles, are lacking biomarkers to evaluate the longitudinal multivariate effects of cancer treatments such as chemotherapy, checkpoint inhibitors, vaccines, etc.
Flow cytometry has long been a mainstay of the diagnostic regime for hematological cancers, such as leukemias and lymphomas. Now with the rise of immunotherapies, CGI is leveraging this well-established technology in innovative ways to add further value to patient treatment decisions and clinical trial enrichment / stratification in IO trials. Traditional methods such as immunohistochemistry (IHC) are insufficient to fully inform therapy dose and scheduling. And, as IO drugs become more commonplace both as mono- and combination therapies, improved and more comprehensive technology is required to monitor and stratify patient populations during clinical trials. Complete::IOTM was precisely designed to meet this need!
Complete::IO™ is a 10-color flow cytometry panel that allows the identification of rare and challenging subsets of immune cells. It can determine precise details of anti-tumor immunity for each cancer patient as it detects multiple markers on an individual cell, which is limited when utilizing other technology platforms, including next-generation sequencing (NGS) and IHC. It is ideal for immune endpoint and immune monitoring of patients allowing informed therapeutic decisions and assessment of potential toxicities of IO therapies in both hematological malignancies and solid tumors.
We have built this assay on our previous experience in custom design and development of high-performance biomarker panels for various cancer indications. This has provided us the insight to be able to optimize reagent combinations in order to minimize cost and unwanted technical bias. The panel analyzes dynamic changes across comprehensive immune cell populations.
Besides the commonly studied subsets, Complete::IO™ is able to provide highly accurate immunophenotyping of central memory, effector, effector memory, naïve CD4+ and CD8+ T cells, T-regs, B-regs, NK, and plasmacytoid dendritic cells. Complete::IO™ allows the query of both circulating cell populations and tumor microenvironment, as it can be performed on fresh tumor biopsies. The workflow has been specifically designed to maximize information yield from smaller samples. We have implemented streamlined specimen setup and reporting for turnaround times as short as 24 hours.
At CGI we are constantly innovating around new and existing technologies to further biomarker driven clinical trials and personalized medicine. Complete::IO™ is just the latest addition to our burgeoning IO portfolio.
We believe Complete::IO™ will become a key tool for cancer centers and hospitals nationally in selecting patients, monitoring response, and predicting toxicities in IO therapies. Our biopharmaceutical partners are already implementing this flow panel for heme and solid tumor clinical trials in such indications as glioblastoma. We expect Complete::IO™ to be utilized to improve the great potential of IO drugs and become a key tool in addressing the inherent complications of assessing response and dose scheduling in immunotherapy treatments.
To learn more about this novel profiling tool or to schedule a conversation with our medical directors and assay development scientists who developed and validated this panel, please send me a note. I’d be happy to schedule time to help evaluate and discuss how this panel and others on the CGI menu could be used to meet your clinical trial and drug development needs.
Anna Israyelyan, MD, PhD
Manager, BioPharma Solutions
Tel: 323.224.3900 x175