Cancer Genetics, Inc., (CGI), a biotech firm focused on the emerging fields of personalized medicine and immuno-oncology, reports the launch of its portfolio of comprehensive new tests and technologies to help measure and monitor immuno-oncology markers, and to select patients for targeted therapies. CGI’s portfolio will be available for clinical trials, patient care, and translational research at the company’s facilities in Rutherford, New Jersey, and Los Angeles.
The company’s newly acquired, Los Angeles-based Center of Excellence For Solid Tumor Testing — formerly Response Genetics — will offer the FDA-approved PDL-1 antibody to be used for selecting patients most likely to benefit from key immuno-oncology drugs. CGI says its proprietary tests and state-of-the-art reference laboratory are equipped to provide critical genomic information, helping physicians diagnose and monitor cancer treatment.
CGI’s Select One Clinical Trials program offers a broad range of services for both oncology and non-oncology genetic testing to support Phase 1-3 trials, as well as ancillary services including bioinformatics, biorepository, and logistic support. The Select One program was created to fulfill CGI’s corporate mission to enhance the success of clinical trials by focusing on the increasing needs for new biomarkers.
Immuno-oncology is an emerging approach to cancer treatment that seeks to harness the body’s own immune system to fight tumor cells. CGI notes that several “blockbuster” immuno-oncology therapies have recently entered the market as treatments for non-small cell lung cancer and melanoma, and some of these drugs require the identification of patients with a high likelihood of response.
The company says clinical trials of targeted therapies under development, as well as many existing approved oncology drugs, are undergoing clinical research to identify patient groups that can best benefit from stimulating anti-cancer immune response, with the target objective to achieve a more durable and effective response to the therapy. In a release, CGI cites a market research firm, IMS Health, report saying Wall Street analysts project more than $35 billion in annual worldwide sales of immuno-oncology drugs by 2024, accounting for roughly half of all spending on cancer drugs and potentially impacting the treatment received by up to 60 percent of all cancer patients. It notes that pharmaceutical analysts project that major pharmaceutical companies are expected to spend nearly $1 billion annually on immuno-oncology research, early access, and development programs and clinical trials.
CGI points out that while immuno-oncology drugs by themselves have been shown highly effective in 20–30 percent of patients, combination therapies hold the promise of more significant patient benefits. Immune-oncology biomarkers and tests that can assess the effectiveness of these therapies, it says, will play a key role in developing more effective treatments with fewer side effects.
“In an era of precision and increasingly personalized therapy, the healthcare industry demands cost-effective options that can robustly identify biomarkers to help select cancer patients most likely to benefit from the emerging class of immuno-oncology drugs,” said CGI president and CEO, Panna Sharma. “CGI has prepared an extensive portfolio of technologies ranging from Immunohistochemistry (IHC) and immuno-phenotyping by flow cytometry to RNA-sequencing. These technologies address the tremendous demand we are experiencing by providing both genomic and immune-marker information to clinical trials and patient care.”
CGI’s portfolio includes immunohistochemistry (IHC)-based tests that can detect novel biomarkers like PD-1 and PD-L1, and flow cytometry-based tests and panels that can assess immune response against cancers by evaluating subsets of immunomodulatory and effector cells. Also on offer is a next-generation targeted RNA sequencing test for measuring expression levels of drug targets, tumor infiltrate composition, and total immune cell composition. The company says many of these assays are also available for clinical use and are FDA Clinical Laboratory Improvement Amendments (CLIA)- and New York State-approved.
Programmed cell death protein 1, commonly referred to as PD-1, and its ligands, PD-L1 and PD-L2, have been shown to promote growth of central nervous system tumors such as glioblastoma, as well as some non-CNS solid tumors including lung, gastric, pancreatic, and other cancers.
Encoded by the PDCD1 gene, PD-1 is a cell surface receptor belonging to the immunoglobulin superfamily and is expressed on T-cells and pro-B-cells, and binds two ligands, PD-L1 and PD-L2. PD-1 functions as an immune checkpoint, a molecule in the immune system that plays an important role in downregulating immune system response by preventing T-cell activation, thereby diminishing autoimmunity and promoting self-tolerance. Cancers protect themselves from the immune system by inhibiting T-cell signals, which, in the case of PD-1, activates a dual mechanism that promotes apoptosis (programmed cell death) in antigen specific T-cells in lymph nodes while simultaneously reducing apoptosis in regulatory suppressor T-cells.
Several drugs targeting PD-1/PD-L1 interactions are currently either FDA approved or in clinical trials, and assessment of PD-L1 expression on tumor cells and in tumor microenvironments is currently used as a biomarker for immunotherapies in patients for whom first-line treatment for non-small cell lung cancer (NSCLC), melanoma, colon cancer, bladder cancer, and hematologic malignancies, among others, has been unsuccessful.
CGI offers commercial anti-PD-L1 staining and assessment assays using IHC on formalin-fixed paraffin-embedded (FFPE) tissue for multiple tumor indications, including NSCLC, colon adenocarcinoma, melanoma, and several subtypes of non-Hodgkin lymphoma. The company’s surgical and hemato-pathology team facilitates evaluation of these markers using complex scoring schemes. CGI also has the capability to integrate genomic and other biomarker data with immune-marker status to provide a systems approach to measuring and monitoring patients’ suitability for immuno-oncology treatments.
CGI has locations in the U.S., India and China, and has established clinical research collaborations with major cancer centers such as Memorial Sloan Kettering, The Cleveland Clinic, Mayo Clinic, Keck School of Medicine at USC and the National Cancer Institute.
Cancer Genetics, Inc.