Sunnyvale, California-based CellMax Life said today that it has partnered with Taiwan-based Medigen Biotech as part of the firm’s cell therapy clinical trials. Medigen will integrate CellMax’s CMx circulating tumor cell (CTC) platform with its liquid biopsy panel to examine patient treatment selection and response.
As part of the open-label, multicenter, single arm clinical trial, the team plans to enroll patients with stage II and III colorectal cancer that has separately been surgically resected or in addition to being treated with chemotherapy.
The partners will start the Phase I trial later this year with patients who test positive on the CMx test to receive the natural killer cell therapy treatment. The firms have designed the trial to track patients’ cancer status multiple times during treatment, using the CMx blood test to determine treatment response.
CellMax’s blood test isolates and analyzes both CTCs and cell-free DNA from a sample of blood to detect six types of analytes, including four classes of genomic mutations, microsatellite instability, and CTCs.
“Colorectal cancer is the second deadliest cancer in the US with 150,000 new cases and $14 billion spent on treatment annually,” CellMax Cofounder and CEO Atul Sharan said in a statement. “Medigen’s vision to develop innovative cancer therapies especially for the earlier stages of cancer when it is most treatable, is very much aligned to CellMax Life’s mission not reduce mortality from colorectal cancer.”
Financial details of the agreement were not disclosed.
“Because we expect to recruit patients with early-stage cancer, test sensitivity was the key criteria for platform selection,” Medigen Chairman and CEO Stanley Chang said in a statement. “By combining the CMx assay with the CellMax ct-DNA liquid biopsy … we hope to have the most sensitive test for treatment selection and monitoring response.”
Chicago Tribune | June 27, 2018 —
Medical tests save lives. Discovering diseases before they become more serious can mean the difference between life and death. But many Americans say they don’t have time to see a doctor, live too far from a medical facility or are so uncomfortable with examinations that they avoid tests altogether.
These challenges have created a demand for home-based medical tests. The market is exploding as businesses bet that consumers prefer the convenience and privacy of home testing.
Colorectal Cancer Is on the Rise in Young Adults
They’re reluctant to have invasive colonoscopies, but a simple blood test could improve compliance
By Shai Friedland
There has been increasing attention directed towards the rising rate of colorectal cancer in younger age groups. In the United States, there was a 51 percent increase in colorectal cancer incidence in adults younger than 55 years old between 1994 and 2014. Partly in response to this alarming trend, the American Cancer Society (ACS) lowered the recommended age at which to begin screening from 50 to 45. Several screening options exist, although the two prominent ones in the United States are colonoscopy and fecal immunochemical tests (FIT), stool tests that detect small amounts of blood. In practice, FIT is used to select a subset of patients for colonoscopy—those with a higher amount of blood in the stool than the threshold set by the laboratory, as blood in the stool is commonly associated with cancer.
Cancer diagnostics company CellMaxLife launched Zenith, the U.S. trial of its circulating tumor cell blood test to detect colorectal cancer.
Here are four things to know:
1. Patients coming in for routine colorectal cancer screening through colonoscopy or stool tests will be offered CellMaxLife’s blood test, and the results will be compared to the colonoscopy and stool test results.
2. CellMaxLife is partnering with medical centers such as Stanford (Calif.) Medicine, the U.S. Department of Veterans Affairs Palo Alto (Calif.) Health Care System, Baltimore-based Johns Hopkins and the University of Southern California in Los Angeles for the study.
3. A previous trial in Asia found that the test can detect colorectal cancer at an early stage with between 84 and 88 percent accuracy, according to results presented at the 2018 ASCO Gastrointestinal Cancer Symposium in January.
4. CellMaxLife will pursue reimbursement for the test by submitting it through the Parallel Review Program for FDA approval and CMS coverage determination. The test requires one tube of blood and is at a price point of less than $200.
ASCO Reading Room A new blood test appears to detect expression of the programmed death-ligand 1 (PD-L1) protein in circulating tumor cells (CTCs) with high sensitivity, enabling repeat testing to monitor a patient’s response to immunotherapy throughout the course of treatment.
The test is able to capture CTCs for PD-L1 testing in blood in about 90% of patients, the researchers said. About half of the CTC-tested patients were PD-L1 positive, which is consistent with previously reported PD-L1-positivity rates in clinical trials.
Under the agreement, CellMax will combine its technology for CTC isolation with IncellDx’s proprietary BioINK microfluidic reagents. Tests will be processed at CellMax’s CLIA lab in Sunnyvale, California and will be jointly marketed in the US by its sales force.
Additional terms of the agreement were not disclosed.
CellMax CEO Atul Sharan said in a statement that IncellDx’s reagent platform will bring “tremendous added value” to its tests. The first project will be to commercialize a blood-based PD-L1 assay based on analysis of both RNA and protein in captured CTCs, to be used in immunotherapy selection and monitoring.
The first generation of tests developed to measure PD-L1 required a biopsy sample of a patient’s tumor. Because blood-based testing is less invasive, easier, and can be performed repeatedly, it offers potential advantages over available assays.
CellMax and IncellDx intend to present performance data for their CTC-based PD-L1 test in non-small cell lung cancer at the annual meeting of the American Association for Cancer Research later this month.
According to the companies, the CellMax technology has been able to capture CTCs for PD-L1 testing in about 90 percent of patients across all stages of NSCLC, with about 50 percent testing PD-L1 positive.
SUNNYVALE, CALIF. (PRWEB) MARCH 28, 2018
CellMax Life, a leading cancer diagnostics company enabling early cancer detection with affordable non-invasive blood tests, announced today the U.S. launch of a blood test to detect the expression of PD-L1 – a key protein involved in suppressing the immune system – in circulating tumor cells (CTCs). Since immunotherapies work only on a minority of patients, identifying cancer patients expressing the PD-L1 protein in CTCs can help determine if they will benefit from the treatment, sparing significant costs and potential side effects.
A study on early and late stage lung cancer patients was recently completed, and the data will be shared at the upcoming American Association for Cancer Research (AACR) conference in Chicago on April 14 through 18. The test was able to capture CTCs for PD-L1 testing in blood in about 90 percent of tested patients. Conversely, tissue can be insufficient or unavailable for testing in 25 to 50 percent of advanced lung cancer patients. About 50 percent of the CTC tested patients were PD-L1 positive; this is consistent with previously reported PD-L1 positivity rates in clinical studies.
Dr. David Gandara, oncologist and director of the Thoracic Oncology Program at University of California, Davis, said: “PD-L1 testing by immunohistochemistry is a standard of care as a predictive biomarker for checkpoint immunotherapy. Blood-based testing offers three potential advantages. First, about 25 percent of patients have inadequate tumor tissue upfront to test for both molecular biomarkers and PD-L1. Second, PD-L1 is a dynamic biomarker, which can change over time, so using tumor from a prior biopsy may be misleading. PD-L1 can also be unevenly distributed in tissue, leading to a false negative and denying patients the opportunity to receive immunotherapy. Lastly, looking to the future, blood-based testing provides a means for repeat testing and timely monitoring, which would not be possible otherwise. A PD-L1 blood test can overcome current issues and would be an attractive alternative to tissue testing.”
“For the 1.7 million people diagnosed with cancer annually in the United States, and the 14.8 million people living with cancer there is no affordable, non-invasive and effective way to monitor patients for treatment response or cancer recurrence,” said Atul Sharan, CEO of CellMax Life. “With the invasiveness of tissue testing and high costs and limitations of existing DNA-based liquid biopsies, conducting repeat testing has been impractical, and often, impossible. CellMax CTC blood tests offer a solution to this major unmet need. We are also seeing a lot of interest from biopharmaceutical companies who want to partner with us to de-risk their clinical trials by using CTCs to monitor patients and identify non-responders to their drug early.”
CellMax Life also analyzes circulating tumor DNA (ctDNA) in the blood sample. The combination of DNA and CTC analysis makes the CellMax liquid biopsy the first and only blood test that includes all mutation classes recommended in the guidelines of the National Comprehensive Cancer Network (NCCN) for immunotherapy and targeted therapy selection in patients with advanced solid tumors.
About CellMax Life
CellMax Life is a leading cancer diagnostics company whose mission is to transform how cancer is diagnosed and managed with globally affordable non-invasive tests for early cancer detection and management. CellMax Life’s unique expertise in circulating tumor cells (CTC) and next generation sequencing (NGS) of DNA, as well as circulating tumor DNA (ctDNA) has enabled it to offer highly effective precision medicine solutions for healthy people, as well as patients diagnosed with cancer.
CellMax Life’s tests include CellMax-DNA Hereditary Cancer Risk Test, CellMax-CRC Colorectal Cancer Screening Test, CellMax-Prostate Cancer Test, CellMax-LBx Liquid Biopsy for immunotherapy and targeted therapy selection and CellMax-PanCa Monitoring Test. All clinical testing is performed at CLIA and CAP accredited laboratories in Sunnyvale, California and Taipei, Taiwan.
For additional information, please visit http://www.cellmaxlife.com.