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SAN JOSE, Calif.—Revisiting old data with new tools can often shed light on facts that had previously been inaccessible, or further confirm previous conclusions, and such is the case for ITUS Corporation and Serametrix. The former announced this week that the companies had completed a study in prostate cancer that re-analyzed data from a collaboration between Serametrix and Memorial Sloan Kettering Cancer Center using ITUS' Cchek technology.
Dr. Amit Kumar, ITUS chairman and CEO, stated, "This is the first time Cchek has been used on samples provided by a third party in a blinded manner, and the results were exceptional. Additionally, this is the largest study of a single type of cancer that we have completed to date. The samples were collected at MSK from patients with biopsy-verified metastatic prostate cancer. These, together with samples from healthy donors, were analyzed by Serametrix to identify a unique sub-type of MDSCs using proprietary technology. A subset of the data was then sent to ITUS for training of our Neural Network, followed by analysis of the remaining samples in a blinded manner."
The company's Cchek platform consists of a series of non-invasive blood tests for early detection of solid tumor-based cancers based on the body's immunological response to the presence of malignancies. According to ITUS, the platform offers new options in the markets of screening, confirmatory testing (especially given Cchek's low rate of false positives), treatment monitoring and recurrence monitoring, though the initial focus will be on its confirmatory abilities. A day before the announcement with Serametrix, ITUS shared news that the U.S. Patent and Trademark Office had issued its second patent to protect the cancer detection technology that forms the backbone of Cchek.
As ITUS explains on its website, “Myloid cells are a certain type of immune cell which emanate from stem cells in the bone marrow and travel to the site of the tumor. Cancer cells impede the normal development of these myeloid cells and subvert their usual function. Once corrupted by the cancer, these cells engage in immune-suppressive activities and become known as Myeloid Derived Suppressor Cells (MDSCs).”
“MDSCs are the subject of ongoing cutting-edge research and have been targeted by the newest immunotherapy drugs,” the company adds. “ITUS has identified certain sub-classes of MDSCs as being diagnostic in nature and has developed proprietary protocols for detecting the cells in the blood of cancer patients.”
Serametrix echoes the importance of this cell subtype, reporting on its website that “MDSCs inhibit T-cell proliferation and permit continued tumor growth. Their abundance is associated with poor prognoses, and elevated levels of MDSCs can render cancer patients less able to derive clinical benefit from immunotherapies. In one study of 26 patients receiving immunotherapy, it was found that patients with relatively low levels of MDSCs at baseline were more likely to respond well to immunotherapy. Furthermore, it was observed that non-responders not only had elevated MDSC at baseline but more frequently had an upward trend during immunotherapy treatment.” Serametrix offers MDSC testing in cancer patients, a test that is part of its icScore, an immune monitoring tool developed to give patients answers as to what immunotherapy options they might respond to. The test received CLIA approval in September 2016. Serametrix licensed the assay, which was developed at the Ludwig Center at MSK, in 2013.
In Serametrix's previous work with MSKCC, it analyzed samples from metastatic prostate cancer patients and normal healthy patients using the MSKCC proprietary assay and algorithm to measure the presence of MDSCs. In this most recent work, Serametrix and ITUS performed a blinded re-analysis of the data using Cchek and saw 92-percent sensitivity and 92-percent specificity when analyzing 121 prostate cancer samples and 125 healthy donor samples. Following the initial analysis, the platform was trained on the samples of 85 prostate cancer samples and 88 healthy donor samples. ITUS received an additional 73 blinded samples, and the retrained Cchek platform was able to identify 33 of 36 prostate cancer samples and 34 of 37 healthy donor samples.
"The results that Serametrix and ITUS were able to obtain are compelling, as it suggests real potential to distinguish tumor-bearing individuals from healthy donors,” commented Dr. Karen Autio, Medical Oncologist and member of the Genitourinary Service and the Melanoma and Immunotherapy Service at MSK. “We also look forward to further studies that will evaluate the prospects for this technology in predicting which patients are most likely to benefit from immuno-oncology therapies, as well as shed light on why prostate cancer has historically been more challenging to treat with immunotherapy in contrast to tumors such as melanoma."
In the future, ITUS will be investigating—together with Serametrix—if Cchek has any utility in determining which patients might and might not respond to immunotherapies. Henry Hepburne-Scott, vice president of Business Development at Serametrix, added in a press release that “Validating the discriminating ability of Cchek using patient samples with localized prostate cancer as compared to normal volunteers will be an important next step.”