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Ignite Proteomics Announces Publication of Study Demonstrating Superiority of Protein Activation Analysis in Predicting Breast Cancer Therapy Response

1. Study shows protein activation predicts cancer therapy responses better than genomic profiling. 2. Patients with active AKT-mTOR showed poor response to standard treatments. 3. Ignite's assay quantifies protein activation, offering better insights for therapy choices. 4. Genomic alterations alone do not predict treatment efficacy in cancer therapies. 5. Integrating proteomic analysis can personalize therapy based on tumor behavior.

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Why Bullish?

The findings enhance Ignite's market position in precision oncology, potentially boosting BACK's stock. Similar advancements in personalized medicine have resulted in stock growth for companies adopting such technologies.

How important is it?

This study directly supports Ignite's core business strategy, likely enhancing investor confidence. High relevance to cancer treatment advancements contributes to its overall importance for BACK.

Why Long Term?

As precision medicine evolves, sustained adoption of proteomic analysis will likely improve BACK's market share over time. This aligns with historical trends where companies leading in innovation enjoy prolonged stock appreciation.

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IMACAKTmTOR
The new study adds to growing evidence that measuring activated proteins is key to cancer therapy selection. Golden, CO, Feb. 10, 2025 (GLOBE NEWSWIRE) -- Ignite Proteomics LLC, a subsidiary of IMAC Holdings, Inc. (Nasdaq: BACK), announces the publication of a significant study in the British Journal of Cancer titled "Functional activation of the AKT–mTOR signalling axis in a real-world metastatic breast cancer cohort". This research underscores the critical importance of measuring functional protein activation within the AKT–mTOR signaling pathway to accurately predict patient responses to targeted cancer therapies. Advancing Precision Oncology Through Direct Protein Activation Measurement The study, coordinated by Perthera (McLean, VA) and a patient-centered initiative sponsored by the Side-Out Foundation, reveals that direct assessment of protein activation provides a superior method for predicting therapeutic outcomes compared to genomic profiling alone. The mutation status of tumors, determined through genomic analyses, did not correlate with protein activation levels and failed to adequately predict patient response. Key Findings: Protein Activation Predicts Therapeutic Response: Patients exhibiting functional activation of the AKT–mTOR signaling axis demonstrated significantly worse response to standard of care first-line treatment with a CDK4/6 inhibitor.Genomic Alterations Do Not Reflect Protein Activity: The study found no correlation between genomic mutations in the PIK3CA, PTEN, or AKT genes and the activation status of corresponding proteins in the pathway. Enhanced Clinical Outcomes Through Proteomic Profiling: Utilizing protein activation analysis allowed for more precise identification of patients likely to benefit from endocrine therapy in combination with a CDK4/6 inhibitor. "This study highlights the limitations of relying solely on genomic data for treatment decisions," said Mariaelena Pierobon, MD, MPH, senior author of the study. "By directly measuring the activation status of proteins in the AKT–mTOR pathway, we may more accurately predict which patients will respond to specific targeted therapies." Implications for the AKT–mTOR Signaling Pathway and Cancer Treatment The AKT–mTOR pathway plays a pivotal role in cell growth, proliferation, and survival. Dysregulation of this pathway is implicated in the progression of various cancers, including metastatic breast cancer. Traditional genomic testing often misses the functional activation state of key proteins, potentially leading to less effective treatment choices. Ignite Proteomics' Advanced Assay Offers a Solution: Direct Measurement of Protein Activation: The company's Reverse Phase Protein Array (RPPA)-based proteomic assay quantifies the phosphorylation (activation) status of proteins within the AKT–mTOR pathway.Superior to Genomic Profiling: By focusing on protein function rather than genetic mutations, the assay provides actionable insights that can guide more effective treatment strategies. Clinical Utility Demonstrated in Real-World Cohort The study analyzed tumor samples from a cohort of metastatic breast cancer patients. Key observations include: Lack of Correlation Between Genomics and Proteomics: Genomic alterations were not predictive of protein activation levels or patient outcomes.Proteomic Profiling Predicts Response to CDK4/6 inhibitors: Patients with an activated AKT–mTOR signaling axis showed worse clinical response to endocrine therapy in combination with a CDK4/6 inhibitor, evidenced by shorter progression-free survival.Potential to Personalize Therapy: The findings support the integration of proteomic analysis into clinical practice to tailor treatments based on functional protein activity. "This research validates the potential of our proteomic assay in personalizing cancer treatment," said Justin Davis, PhD, Vice President of Research and Development at Ignite Proteomics and a co-author of the study. "By measuring the actual drivers of tumor behavior – activated proteins – we enable clinicians to make more informed decisions that can significantly improve patient outcomes." Building on Existing Evidence This new study adds to existing evidence that measuring activated protein levels is key to predicting response – or non-response – to new therapies. One study from 2022 deserves to be highlighted: Functional Mapping of AKT Signaling and Biomarkers of Response from the FAIRLANE Trial of Neoadjuvant Ipatasertib plus Paclitaxel for Triple-Negative Breast Cancer, published in Clinical Cancer Research. Researchers analyzed activated AKT protein levels by RPPA and also alterations in genes by standard genomic testing and concluded that “phosphorylated AKT (pAKT) levels exhibited a significant association with enriched clinical benefit of ipatasertib, and identified patients who received benefit in the absence of PIK3CA/AKT1/PTEN [genomic] alterations.” Advancing Precision Medicine with Ignite Proteomics Ignite Proteomics offers the only commercially available and clinically validated assay that measures both the expression and activation levels of drug targets in breast tumors. This innovative approach empowers oncologists to select therapies that are more likely to be effective based on the tumor's unique proteomic profile. About Ignite Proteomics Ignite Proteomics LLC, a subsidiary of IMAC Holdings, specializes in advanced Reverse Phase Protein Array (RPPA) technology for cancer diagnostics. As a leader in protein activation analysis, and operating under a CLIA-accredited lab, Ignite provides a single test covering multiple markers to help doctors pinpoint the most suitable therapies, bridging the gap that gene-focused methods leave behind. Several key markers in the assay are protected by licensed patents. About IMAC Holdings, Inc. IMAC Holdings, Inc. strives to improve patient outcomes through innovative healthcare solutions. By combining strategic acquisitions and innovative technologies, IMAC Holdings remains committed to advancing personalized medicine. IMAC Holdings has begun the process to change its name and will soon be shown as IMAC Holdings, Inc, DBA Ignite Sciences, Inc. For Additional Information, Please Contact: Email: Investors@imacholdings.comWebsite: www.igniteproteomics.com Study location: https://www.nature.com/articles/s41416-024-02852-y FAIRLANE Trial: https://pubmed.ncbi.nlm.nih.gov/34907082/ Non-Scientific Summary In simple terms, this research shows that looking only at cancer’s DNA changes doesn’t always reveal which treatments will work. The actual proteins, and whether they’re “switched on,” matter more. Many modern cancer therapies either aim to shut down these active proteins or deliver potent drugs directly to them. By directly measuring protein activation, our test gives doctors better insight into which therapy is likely to be effective or which therapies should be avoided. This study – and a similar one we highlighted – both confirm that the “active” status of a protein can be the key to predicting how well a cancer drug will perform.

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