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Theralink announces groundbreaking RPPA study by partner GMU - reveals novel therapy options for hard-to-treat breast cancer patients that could lead to significant improvements in response rates

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Theralink Technologies (THER) announces groundbreaking findings from the ISPY-2 trial, revealing new therapeutic options for challenging breast cancers using RPPA technology. The study identified HARPS, a protein biomarker, for more effective stratification of Triple Negative Breast Cancer patients, potentially leading to ~80% response rates compared to the current 30-40%.
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Golden, Colorado & Nashville, Tennessee, Dec. 18, 2023 (GLOBE NEWSWIRE) -- Theralink Technologies (OTC: THER), a precision oncology company with an exclusively licensed commercial RPPA (reverse phase protein array) technology platform, is excited to announce groundbreaking work by George Mason University and the University of California, San Francisco, recently published in Cell Reports Medicine (https://linkinghub.elsevier.com/retrieve/pii/S2666379123005062). This incredible effort coming from the ISPY-2 trial assessed the tumors from over 700 breast cancer patients via RPPA and uncovered new therapeutic options for some of the most challenging breast cancers that are missed entirely by current diagnostic approaches.

One of the many significant findings of the study is a clinically powerful RPPA-identified protein biomarkers, referred to as HARPS (HER2 Activation Response Predictive Signature). The investigators found that HARPS can be used to stratify patients with Triple Negative Breast Cancer (TNBC), the most difficult to treat breast cancer, in order to administer more appropriate treatments and will likely lead to significantly improved responses to therapy. “We were very excited to discover that the RPPA-based HARPS signature could be used for more effective stratification of TNBC into existing therapies that would potentially result in ~80% response rates. This is compared to the current 30-40% response rates and this signature is entirely based on the RPPA proteomic signatures.” explained Emanuel F Petricoin, Co-Director of Mason’s Center for Applied Proteomics and Molecular Medicine and senior author of the study.

This study highlights the critical need for the availability of the RPPA technology in the clinic, as the currently available methods have various limitations that rely on making predictions about proteins. In contrast, RPPA is a powerful and highly sensitive technology that directly measures a protein. This study highlights the critical need to understand proteins in cancer management, as nearly all FDA-approved targeted therapeutics for breast cancer are designed to target proteins. Patients were treated with targeted therapeutics based on these RPPA HARP signature findings, and the response rate to treatment was an astonishing 80% - an unheard-of number for TNBC patients. Breakthroughs like this will save lives and dramatically reduce the cost of unnecessary and ineffective treatments. From Faith Zaslavsky, President and CEO of Theralink Technologies, “We are extremely proud of the work being done by Dr. Petricoin and his team at George Mason University and are proud to be able to commercialize these efforts. Breakthroughs like this will save lives and dramatically reduce the cost of unnecessary and ineffective treatments.”

In addition to the RPPA discovery of the HARP signature, the investigators analyzed other RPPA-based protein biomarkers that indicate cancer resistance to therapy and revealed many previously unrecognized but druggable protein targets. As the current treatments for patients with TNBC and other breast cancer subtypes are often unsuccessful due to the lack of identifiable targets, the sooner physicians have access to RPPA to measure critical protein biomarkers, the sooner these patients can benefit from effective treatments.

The same RPPA technology reported in this study is commercially available through Theralink’s Assay for Breast Cancer, with 40% of assays ordered through the lab currently are for these challenging to manage patients with TNBC. With TNBC comprising up to 20% of all breast cancers, the utilization of this assay indicates a current and growing need to use RPPA technology to determine treatment for this population of patients. “This is why it is so exciting for me to see the RPPA technology that we invented and refined in my research laboratory be commercialized and used at the bedside by Theralink for patient benefit. Through ongoing clinical implementation and evaluation of the RPPA platform and underlying protein drug target biomarkers we can continue to rigorously and extensively validate these findings” said Petricoin, a Distinguished University Professor in the Mason Science School of Systems Biology.

About Theralink Technologies, Inc.
Theralink Technologies is a proteomics-based, precision medicine company with a CLIA-certified and CAP-accredited laboratory located in Golden, Colorado. Through its unique and patented phosphoprotein and protein biomarker platform and LDTs, Theralink's technology targets multiple areas of oncology and drug development. In addition to the Company's first assay for advanced breast cancer, Theralink is actively working on a second assay that is planned to be pan-tumor for solid tumors across multiple tumor types such as ovarian, endometrial, pancreatic, liver, head and neck, colorectal, lung, prostate, among others. Theralink provides precision oncology data through its powerful Theralink® Reverse Phase Protein Array assays to assist the biopharmaceutical industry and clinical oncologists in identifying likely responders and non-responders to both FDA-approved and investigational drug treatments. Theralink intends to help improve cancer outcomes for patients, help reveal therapeutic options for oncologists, and support biopharmaceutical drug development by using a beyond-genomics approach to molecular profiling that directly measures drug target levels and activity. For more information, please visit www.theralink.com.

Forward-Looking Statements
Cautionary Note Regarding Forward-Looking Statements

This communication contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical fact, included in this communication that address activities, events or developments that IMAC or Theralink expects, believes or anticipates will or may occur in the future are forward-looking statements. Words such as “estimate,” “project,” “predict,” “believe,” “expect,” “anticipate,” “potential,” “create,” “intend,” “could,” “would,” “may,” “plan,” “will,” “guidance,” “look,” “goal,” “future,” “build,” “focus,” “continue,” “strive,” “allow” or the negative of such terms or other variations thereof and words and terms of similar substance used in connection with any discussion of future plans, actions, or events identify forward-looking statements. However, the absence of these words does not mean that the statements are not forward-looking. These forward-looking statements include, but are not limited to, statements regarding the proposed Merger, the expected closing of the proposed Merger and the timing thereof and as adjusted descriptions of the post-transaction company and its operations, strategies and plans, integration, debt levels and leverage ratio, capital expenditures, cash flows and anticipated uses thereof, synergies, opportunities and anticipated future performance, including maintaining current Theralink management. Information adjusted for the proposed Merger should not be considered a forecast of future results. There are a number of risks and uncertainties that could cause actual results to differ materially from the forward-looking statements included in this communication. These include the risk that cost savings, synergies and growth from the proposed Merger may not be fully realized or may take longer to realize than expected; the possibility that shareholders of IMAC may not approve the issuance of new shares of IMAC common stock in the proposed Merger or that shareholders of IMAC may not approve the proposed Merger; the risk that a condition to closing of the proposed Merger may not be satisfied, that either party may terminate the Merger Agreement or that the closing of the proposed Merger might be delayed or not occur at all; potential adverse reactions or changes to business or employee relationships, including those resulting from the announcement or completion of the proposed Merger; the occurrence of any other event, change or other circumstances that could give rise to the termination of the Merger Agreement relating to the proposed Merger; the risk that changes in IMAC’s capital structure and governance could have adverse effects on the market value of its securities and its ability to access the capital markets; the ability of IMAC to retain its Nasdaq listing; the ability of Theralink to retain customers and retain and hire key personnel and maintain relationships with their suppliers and customers and on Theralink’s operating results and business generally; the risk the proposed Merger could distract management from ongoing business operations or cause IMAC and/or Theralink to incur substantial costs; the risk that Theralink may be unable to reduce expenses; the impact of the COVID-19 pandemic, any related economic downturn; the risk of changes in regulations effecting the healthcare industry; and other important factors that could cause actual results to differ materially from those projected. All such factors are difficult to predict and are beyond IMAC’s or Theralink’s control, including those detailed in IMAC’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K that are available on IMAC’s website at www.ir.imacregeneration.com and on the website of the Securities and Exchange Commission (the “SEC”) at www.sec.gov, and those detailed in Theralink’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K that are available on Theralink’s website at www.theralink.com and on the website of the SEC. All forward-looking statements are based on assumptions that IMAC and Theralink believe to be reasonable but that may not prove to be accurate. Any forward-looking statement speaks only as of the date on which such statement is made, and neither IMAC nor Theralink undertakes any obligation to correct or update any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by applicable law. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. 

1 Hunt AL, et al. Integration of Multi-omic Data in a Molecular Tumor Board Reveals EGFR-Associated ALK-Inhibitor Resistance in a Patient With Inflammatory Myofibroblastic Cancer. Oncologist. 2023 Aug 3;28(8):730-736. 

Contact Information
Theralink Technologies, Inc.
Trevor McCartney
VP, Strategic Partnerships
Cell: (720) 800-2160
trevor.mccartney@theralink.com


FAQ

What is the latest announcement from Theralink Technologies (THER)?

Theralink Technologies (THER) revealed groundbreaking findings from the ISPY-2 trial, uncovering new therapeutic options for challenging breast cancers using RPPA technology.

What is the significance of the HARPS protein biomarker in the study by Theralink Technologies (THER)?

The study identified HARPS as a protein biomarker for more effective stratification of Triple Negative Breast Cancer patients, potentially leading to ~80% response rates compared to the current 30-40%.

Who is the senior author of the study announced by Theralink Technologies (THER)?

Emanuel F Petricoin, Co-Director of Mason’s Center for Applied Proteomics and Molecular Medicine, is the senior author of the study.

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