On August 20, 2020 Cofactor Genomics, the company bridging the precision medicine gap, reported that the United States Patent and Trademark Office (USPTO) has granted Patent No. 10636512 protecting the Company’s predictive immune modeling technology (Press release, Cofactor Genomics, AUG 20, 2020, View Source [SID1234563896]). The patent covers translation of RNA present in tumors into immune composition and its use in predicting response to immunotherapy in cancer patients.
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At a time when many companies are using the same short list of technologies to address problems hindering precision medicine, Cofactor has carved out an important niche, using ribonucleic acid (RNA) signals to measure immune-related gene expression signals from formalin-fixed and paraffin embedded (FFPE) solid tumor tissue. Analysis of these signals using the company’s proprietary deconvolution approach and database of immune Health Expression Models (iHEMs) delivers absolute, quantitative immune cell measurements previously unachievable using other commercial and academic approaches. Importantly, the patent covers taking these measurements further into diagnostic development, by integrating the signals into a multidimensional biomarker that predicts response to therapy and represents a unique evolution away from historic panel-based assays.
Specifically, the patent covers applications of predictive immune modeling in immunotherapy, where the indications approved for treatment today represent 50 percent of yearly diagnosed cancer cases and continue to expand. Unfortunately, response rates of drugs, such as immune checkpoint inhibitors, continue to hover at 20 percent, demonstrating the urgent need for predictive diagnostics that accurately identify responders and bridge this precision medicine gap. Cofactor’s technology utilizes the immune response at the site of the tumor for response prediction, improving a physicians’ ability to select the optimal treatment path.
"Potentially life-saving immunotherapies for cancer are introduced every year, but the challenge of identifying which patients can benefit from them clinically is a multi-billion dollar problem that results in lives lost," noted Armen Vidian, partner at DCVC (Data Collective) and an investor and Board Director for Cofactor. "These technologies, immune Health Expression Models and the resulting Predictive Immune Models, represent a science-based approach that defines a new category of diagnostics desperately needed in order to maximize patient benefit affordably."
"There is no precision medicine without precision diagnostics," stated Jarret Glasscock, Cofactor Genomics’ CEO. "Cofactor’s recently patented technology is the cornerstone to our new class of diagnostics. Reaching this milestone involved an inspiring effort from so many individuals and teams at Cofactor, and we will continue our commitment to bringing forth revolutionary technologies to meaningfully benefit patients."
Analytical validation of Cofactor’s immune Health Expression Models (iHEMs) and their application in immune cell quantification was recently published in the Journal of Molecular Diagnostics. Preliminary results from a patient cohort that will be included in Cofactor’s clinical validation of their laboratory-developed test (LDT) were presented at the 2020 ASTRO/ASCO/SITC Multidisciplinary Head and Neck Meeting and demonstrated significant improvements over the on-label PD-L1 test. The company also offers the technology as a research-use-only GMP-manufactured reagent kit, which may be deployed in partner laboratories and CROs, outside of Cofactor’s CAP/CLIA accredited laboratory.