On November 3, 2023 Theralink Technologies, Inc. (OTC: THER) ("Theralink"), a precision oncology company with its exclusive commercial RPPA (reverse phase protein array) technology that can help predict which FDA-approved drug is effective in each cancer, reported that their long-standing, strategic partnership with the Inova Schar Cancer Institute (Inova) is beginning to deliver promising results by way of assessing the feasibility and impact of the actionable information provided by the Theralink assay into Inova’s Molecular Tumor Board (MTB)-based treatment decisioning making for cancer patients (Press release, Theralink Technologies, NOV 4, 2023, View Source [SID1234636909]).
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The partnership involves the integration of the Theralink assay, protected by ten patents, into Inova’s molecular tumor board’s operational workflow. Over the past year, Inova has undertaken a feasibility study to develop and implement the procedures and infrastructure necessary for proteomic analysis within the context of the Inova Schar Molecular Tumor Board. The Theralink assay provides a direct means of determining the actionability of genomic derangements identified, as well as directly measuring the activation/elevation of protein drug targets otherwise missed by genomic analysis alone. Thus, the incorporation of key phosphoprotein and protein data generated by Theralink’s RPPA technology into the Inova MTB could synergize with current genomics analysis to produce more accurate treatment selection and patient-tailored therapy regimes.
Interim results of this pan-tumor study were presented at the 2023 ASCO (Free ASCO Whitepaper) Conference in Chicago. Specifically, the analysis examined the feasibility of incorporating laser capture microdissection (LCM) enrichment of tumor specimens and reverse phase protein array (RPPA) analysis with next generation sequencing (NGS) into a molecular tumor board for improving selection of targeted cancer therapy. Integrated review of the RPPA and NGS data by the MTB supported a clinical recommendation change for over half of the patients overall. Further, the proteomics data from the Theralink assay provided additional treatment considerations for 59% of the patients, the outcomes for whom continue to be monitored. Moreover, the collaboration with Inova and their MTB resulted in a recent finding1 wherein the Theralink proteomics data revealed a specific mechanism of resistance and likely lack of benefit to a targeted therapy being considered by the MTB for a patient with a rare form of inflammatory myofibroblastic cancer.
Lastly, Inova and Theralink presented the results of another important study at ASCO (Free ASCO Whitepaper) 2023 that focused on Theralink’s unique ability to quantitatively measure HER2 abundance and activation and found that nearly 50% of pancreatic tumor actually express moderate amounts of HER2 protein, which could be missed by existing commercial HER2 assays. While HER2 expression is not routinely evaluated in clinical practice for pancreatic cancer these results may have clinical implications, especially as new classes of HER2 antibody drug conjugates are considered for patients with HER2 non amplified tumors across organ sites.
"Theralink is extremely encouraged by the work done to date at Inova Schar Cancer Institute- the interim results and clinical intelligence speak for themselves. We look forward to completing this study with Inova for our mutual goal of improving outcomes for all cancer patients", said Faith Zaslavsky, President and Chief Executive Officer of Theralink.
Dr. Timothy Cannon, who is the Sheridan Director of the Inova Molecular Tumor Board and Co-Director of the Gastrointestinal Cancer Program at Inova said, "We have tested over 100 patients with Theralink’s RPPA technology as part of this study. We are hopeful final study analysis and results will continue to underscore the importance of real-time clinical integration of functional protein drug target activation data provided by the Theralink assay with NGS in the Inova MTB for cancer patients."
Theralink and Inova will update findings and results post study completion. Published results are anticipated in early 2024.