On July 25, 2022 Theralink Technologies, Inc. (OTC: THER) ("Theralink" or the "Company"), a precision oncology company with a novel phosphoprotein-based assay for breast cancer, reported that it has acquired licenses for two new U.S. patents relating to methods for treating breast cancer: US 10,823,738 and US 10,690,672, expanding the Company’s patent portfolio to nine (Press release, Theralink Technologies, JUL 25, 2022, View Source [SID1234616916]).
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Theralink has licensed the patents from George Mason University, strengthening and extending the current Theralink IP family that covers specific "predictive" biomarkers. Predictive biomarkers are used to identify patients with cancer that require specific, personalized therapeutics. In essence, they define what are called "companion diagnostics" wherein the biomarker is used to identify classes of patients that will best respond to a specific drug. Theralink has issued IP on specific predictive biomarkers that cover a range of therapeutic classes.
Emanuel Petricoin, Ph.D., Chair of Theralink’s Science Advisory Board, stated, "These new patents are a significant addition to Theralink’s biomarker collection, greatly enhancing our existing CLIA Theralink Assay portfolio. Together, these two new patents immediately synergize with the commercially available CLIA Theralink Assay for Breast Cancer since the specifically claimed biomarkers, protected by the new issued patents, are part of the 32-biomarker panel that is commercially available today."
Mick Ruxin, M.D., President & CEO of Theralink, added, "These two important patents, along with the existing seven patents in our portfolio, create a substantial IP moat surrounding our patented Reverse Phase Protein Array Technology and provide Theralink with the exclusive commercial license to bring our predictive assay to all cancer patients within the category of intended use. Significantly, physicians can now order the Theralink Assay for Breast Cancer and use it to expand the use of PARP inhibitors and HER2-EGFR inhibitors to breast cancer patients, by identifying patients who will respond to these powerful therapeutics currently missed by existing genomics-based approaches."
New Patent Details:
Issued patent 10,823,738: A Method for Treating Breast Cancer, relates to the use of specific predictive biomarkers that can be used to identify which patients with HER2 negative disease, including the hard-to-treat "triple negative" breast cancer, will respond to the powerful new class of therapeutics called PARP inhibitors. HER2 negative breast cancer represents 80% of all breast cancers, so this subtype is by far the most prevalent type. While PARP inhibitors represent a tremendously exciting new class of therapies in cancer and are known to be effective in HER2- breast cancer, nearly 40% of these HER2 negative patients do not respond, and this patent covers specific biomarkers that predict which patients will and will not respond to PARP inhibitors, effectively, a predictive marker for PARP inhibitors. Moreover, the patent covers the use of specific biomarkers for any type of PARP inhibitor-based therapy.
Issued patent 10,690,672: A Method for Treating Breast Cancer, covers the use of specific predictive biomarkers that can be used to identify which breast cancer patients will respond to therapies that target the HER2 and EGFR proteins in ALL types of breast cancer. While anti-HER2 therapeutics and HER2-EGFR dual therapeutics together represent the largest class of breast cancer therapeutics on the market, amounting to billions of dollars a year in revenue for the pharmaceutical industry, identification of patients who will respond relies on the use of measuring HER2 first, which means that currently only 20% of all breast cancers are treated with this class of therapies. Theralink’s new powerful IP centers on novel biomarkers that can be used for 100% of breast cancers and may identify many patients who will respond to anti-HER2-EGFR agents missed entirely by current HER2 measurement techniques.