Granuloma, Plasma Cell

Golden, Colorado, Nov. 03, 2023 (GLOBE NEWSWIRE) -- 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, today announced 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. 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 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 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. About Theralink Technologies, Inc. Theralink Technologies is a proteomics-based, precision medicine company with a nationally 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. Theralink Technologies, Inc. (OTC: THER) (“Theralink”) and IMAC Holdings, Inc. (Nasdaq: BACK) have entered into a definitive Agreement and Plan of Merger (the “Merger Agreement”) under which Theralink will merge with a newly formed, wholly-owned subsidiary of IMAC in a stock-for-stock reverse merger transaction (the “Merger”) in which Theralink will survive as a wholly-owned subsidiary of IMAC, a Nasdaq-listed company. If completed, the Merger will result in a combined company that will focus on end-to-end proteomics testing, one of the most robust and growing areas of medicine. 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 InformationTheralink Technologies, Inc.Trevor McCartneyVP, Strategic PartnershipsCell: (720) 800-2160trevor.mccartney@theralink.com

Partnership includes a Phase II clinical trial using microbiome therapeutics funded by the Medical Research Council (MRC) aiming to potentiate allo-HCT in patients suffering from haematological malignancy Combines expertise at Imperial with EnteroBiotix's AMPLA™ platform and Medicines and Healthcare products Regulatory Agency (MHRA) licensed facilities GLASGOW, Scotland, Nov. 10, 2022 /PRNewswire/ -- EnteroBiotix Limited ("EBX"), a premier, full-spectrum microbiome therapeutics company, today announced a partnership with Imperial College London ('Imperial') to develop microbiome R&D in patients suffering from blood cancer as well as accelerate systematic research in the new science of the microbiome. EBX and Imperial are partnering to manage a Phase II, a investigator initiated trial, to evaluate how EBX-102 impacts on outcomes of bone marrow transplant patients with blood cancer. This trial forms part of the Microbiota Transplant Prior to Allogeneic Stem Cell Transplantation (MAST) study, run across six of the UK's leading blood cancer centres and includes, along with Imperial, UCLH, The Royal Marsden, King's College London, Leeds Teaching Hospitals, and University Hospitals Birmingham. EBX will provide its lead product, EBX-102, from its MHRA licensed facilities, for the clinical trial. EBX-102 contains diverse ecosystems of microbiota obtained from healthy and rigorously screened donors, offering a compositionally consistent drug product with attractive commercial attributes. EBX manufacturing capabilities include its novel proprietary AMPLA™ platform that enables rapid preparation of dry powder from hydrated starting material. The Medical Research Council funded trial, supported in-kind by EnteroBiotix, will build on Imperial's successful pilot study (in the same patient population) which demonstrated preliminary signals trending towards intestinal microbiota transplantation ("IMT"), reducing complications and improving survival. Imperial will increase exploration into the efficacy of this approach for a range of diseases, as well as to strengthen the route to commercialisation through systematic research. Professor Julian Marchesi of Imperial College London, Department of Metabolism, Digestion and Reproduction, leading the research says: "Patients with blood cancers are a group whose gut microbiome is particularly under attack. They often receive strong chemotherapy, which has side effects of mouth ulcers and gut inflammation. Their nutrition might be poor, they receive frequent antibiotics because of their high rate of infections, and many of them end up colonised with antibiotic-resistant bacteria. That latter point in particular can be a problem when patients need a very demanding treatment, like bone marrow transplantation; haematologists are sometimes anxious about offering this or other treatments because patients are at such high risk of getting an infection which is untreatable. So, we are very excited and pleased to be partnering with EnteroBiotix to use their product to manipulate the gut microbiome in these patients." Dr James McIlroy, Founder and CEO of EnteroBiotix says: "When we founded EnteroBiotix, there were 13 clinical trials listed on clinicaltrials.gov investigating IMT, now there are hundreds. Most of the studies published so far show the same thing – that transferring microorganisms from healthy to sick people can contribute to improving health outcomes. EnteroBiotix is developing a safer and more scalable approach to IMT that is compositionally consistent and is supported by a strong intellectual property position. Partnering with Imperial allows us to explore different research opportunities and takes us closer to fulfilling our vision to develop products that benefit patients." "The early data already generated so far by Imperial is very exciting," he adds. "It is helping to build a strong case for microbiome enhancement. The Imperial team is a discovery engine and EnteroBiotix can help translate that into a commercial product that benefits patients around the world." EnteroBiotix's products have potential applicability across multiple disease areas including immuno-oncology and diseases of the liver-brain axis. Further research will be supported by EnteroBiotix's state-of-the-art GMP manufacturing facility that recently was granted a Manufacturer's licence for Investigational Medicinal Products (IMP) by the Medicines and Healthcare Products Regulatory Agency (MHRA) to manufacture microbiome product candidates for clinical trials. About EnteroBiotix EnteroBiotix is a biopharmaceutical company developing novel medicinal products that enhance the gut microbiome and target multiple disease indications. Established in 2017, EnteroBiotix is headquartered in Glasgow, Scotland and operates research laboratories and MHRA licensed GMP pharmaceutical manufacturing sites in Glasgow and Aberdeen. The company has raised over £20m from investors to date, including ThairmBio, Kineticos Ventures, and Scottish Enterprise Growth Equity. EnteroBiotix has differentiated platform manufacturing technology that has broad potential applicability across the spectrum of microbiome therapeutic approaches. The Company operates a brand called Number 2®, which ensures the safety, security, quality and sufficiency of supply of microbiota obtained from healthy human donors. The Company has a partnership with Imperial College London for microbiome research for a cancer clinical trial. For more details see and . SOURCE EnteroBiotix

Sarah Silbiger/Getty Images BioSpace is excited to introduce FDA Weekly Review, a column that looks at the U.S. Food and Drug Administration’s actions related to drug approvals, IND approvals, Breakthrough and Priority designations and more. Here’s a look at what happened this week. FDA Approvals Avadel Pharmaceuticals announced Tuesday that the FDA has granted tentative approval to Lumryz (FT218). This action indicates that the drug met all required quality, safety and efficacy standards, but final approval is pending resolution of a patent dispute with Jazz Pharma. Lumryz is a once-at-bedtime formulation of sodium oxybate for excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy. The tentative approval was based on data from the Phase III REST-ON trial that showed the drug demonstrated statistically significant and clinically meaningful results in patients with EDS. Avadel CEO Greg Divis said his company is “pursuing all options to accelerate final approval on or before June 2023 and prepare for commercial launch.” Eton Pharmaceuticals announced Monday that the FDA has approved Zonisade (zonisamide oral suspension). The drug was included in Eton’s multi-product neurology oral solution partnership with Azurity Pharmaceuticals announced in February 2021. Azurity is responsible for commercializing the drug. Zonisade was approved as adjunctive therapy for partial seizures in adults and pediatric patients 16 years and older with epilepsy. Amphastar Pharmaceuticals reported FDA approval of its Abbreviated NDA for Vasopressin injection, USP 20 Units/mL, 1mL Single Dose Vial. The drug is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive (with low blood pressure) despite fluids and catecholamines. The agency determined vasopressin is bioequivalent and therapeutic equivalent to Par Sterile Products’ Vasostrict. Pfizer’s Xalkori (crizotinib) was approved for adults and pediatric patients one year and older with unresectable, recurrent or refractory inflammatory anaplastic lymphoma kinase (ALK)-positive myofibroblastic tumors. The approval was based on two open-label trials that included 14 pediatric patients from ADVL0912 and seven adults from A8081013. The major efficacy outcome was objective response rate (ORR). Neuronetics received clearance from the FDA for the use of its transcranial magnetic stimulation (TMS) system, NeuroStar Advanced Therapy for Mental Health, in treating anxiety symptoms in adults with major depressive disorder (MDD), also called anxious depression. The agency accepted Neuronetics’ use of real-world data analyzed from NeuroStar’s TrakStar platform in granting clearance for this indication. Designations Celcuity announced that the FDA has granted gedatolisib Breakthrough Therapy designation for the treatment of patients with HR+/HER2- metastatic breast cancer whose disease progressed during treatment with a CDK4/6 therapy and a non-steroidal aromatase inhibitor. The drug is a potential first-in-class pan-PC3KmTOR inhibitor. The breakthrough application was supported by data from a Phase Ib trial assesing the drug’s safety, tolerability and clinical activity in combination with palbociclib and fulvestrant for this indication. Apellis Pharmaceuticals received Priority Review designation for its new drug application for intravitreal pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration. The PDUFA date is November 26, 2022. The NDA is built on data from the Phase III DERBY and OAKS studies and the Phase II FILLY trial. The drug is a targeted C3 therapy designed to regulate excessive activation of the complement cascade, a part of the immune system. Pliant Therapeutics received Fast Track designation from the FDA for PLN-74809, its oral, dual-selective αvß6 / αvß1 integrin inhibitor, for the potential treatment of primary sclerosing cholangitis (PSC). It is currently being evaluated in the Phase IIa INTEGRIS-PSC clinical trial. Olema Pharmaceuticals received Fast Track designation from the FDA for OP-1250. The drug is an oral complete estrogen receptor (ER) antagonist and selective ER degrader for the treatment of ER-positive, HER2- metastatic breast cancer that has progressed following one or more lines of endocrine therapy with at least one given in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor. New Trials Alzamend Neuro received a positive written response to its meeting request for a Type B Pre-Investigational New Drug (IND) application with the FDA. The response provides a clear path for the company’s planned clinical development of AL001 for bipolar disorder, major depressive disorder and post-traumatic stress disorder. AL001 is a novel lithium-delivery system, a lithium-salicylate-L-proline engineered ionic cocrystal currently being assessed in a Phase II trial for the oral treatment of patients with dementia resulting from mild, moderate or severe cognitive impairment caused by Alzheimer’s disease. The MD Anderson Cancer Center and Obsidian Therapeutics received the go-ahead from the FDA for their IND application to conduct a Phase I trial of OBX-115. The drug is an engineered tumor-infiltrating lymphocyte (TIL) therapy being developed as a monotherapy to treat adults with metastatic melanoma who are relapsed or refractory to previous checkpoint therapy treatments.