Ignite Proteomics Announces Publication of Study Demonstrating Superiority of Protein Activation Analysis in Predicting Breast Cancer Therapy Response
Ignite Proteomics, a subsidiary of IMAC Holdings (Nasdaq: BACK), has published a significant study in the British Journal of Cancer demonstrating the superiority of protein activation analysis in predicting breast cancer therapy response. The research reveals that direct assessment of protein activation provides better prediction of therapeutic outcomes compared to genomic profiling alone.
The study found that patients with functional activation of the AKT-mTOR signaling axis showed worse response to standard first-line treatment with CDK4/6 inhibitors. Importantly, genomic mutations in PIK3CA, PTEN, or AKT genes showed no correlation with protein activation status or patient outcomes.
The company's Reverse Phase Protein Array (RPPA)-based proteomic assay measures protein activation within the AKT-mTOR pathway, offering the only commercially available and clinically validated test that measures both expression and activation levels of drug targets in breast tumors. This approach enables more precise identification of patients likely to benefit from specific targeted therapies.
Ignite Proteomics, una filiale di IMAC Holdings (Nasdaq: BACK), ha pubblicato uno studio significativo nel British Journal of Cancer che dimostra la superiorità dell'analisi dell'attivazione delle proteine nella previsione della risposta alla terapia del cancro al seno. La ricerca rivela che la valutazione diretta dell'attivazione delle proteine fornisce una previsione migliore dei risultati terapeutici rispetto al solo profilo genico.
Lo studio ha trovato che i pazienti con attivazione funzionale dell'asse di segnalazione AKT-mTOR mostrano una risposta peggiore al trattamento di prima linea standard con inibitori CDK4/6. È importante notare che le mutazioni genomiche nei geni PIK3CA, PTEN o AKT non hanno mostrato correlazione con lo stato di attivazione delle proteine o i risultati dei pazienti.
Il saggio proteomico basato su Reverse Phase Protein Array (RPPA) dell'azienda misura l'attivazione delle proteine all'interno della via AKT-mTOR, offrendo l'unico test clinicamente validato e disponibile commercialmente che misura sia i livelli di espressione che quelli di attivazione dei bersagli farmacologici nei tumori mammari. Questo approccio consente un'identificazione più precisa dei pazienti che potrebbero beneficiare di specifiche terapie mirate.
Ignite Proteomics, una subsidiaria de IMAC Holdings (Nasdaq: BACK), ha publicado un estudio significativo en el British Journal of Cancer que demuestra la superioridad del análisis de activación de proteínas para predecir la respuesta a la terapia del cáncer de mama. La investigación revela que la evaluación directa de la activación de proteínas proporciona una mejor predicción de los resultados terapéuticos en comparación con el perfil genómico por sí solo.
El estudio encontró que los pacientes con activación funcional del eje de señalización AKT-mTOR mostraron una peor respuesta al tratamiento estándar de primera línea con inhibidores de CDK4/6. Es importante destacar que las mutaciones genómicas en los genes PIK3CA, PTEN o AKT no mostraron correlación con el estado de activación de proteínas ni con los resultados de los pacientes.
El ensayo proteómico de la compañía basado en Reverse Phase Protein Array (RPPA) mide la activación de proteínas dentro de la vía AKT-mTOR, ofreciendo la única prueba clínicamente validada y disponible comercialmente que mide tanto los niveles de expresión como los de activación de los objetivos terapéuticos en tumores de mama. Este enfoque permite una identificación más precisa de los pacientes que probablemente se beneficiarán de terapias específicas dirigidas.
Ignite Proteomics는 IMAC Holdings (Nasdaq: BACK)의 자회사로, 영국 암 저널에 유방암 치료 반응 예측에서 단백질 활성 분석의 우수성을 보여주는 중요한 연구 결과를 발표했습니다. 연구에 따르면, 단백질 활성의 직접적인 평가가 유전자 프로파일링 단독보다 치료 결과를 더 잘 예측하는 것으로 나타났습니다.
연구에서는 AKT-mTOR 신호 전달 축의 기능적 활성화가 있는 환자의 경우 CDK4/6 억제제에 대한 표준 1차 치료 반응이 더 나쁘다는 결과가 나왔습니다. 중요한 것은, PIK3CA, PTEN 또는 AKT 유전자의 유전자 변이가 단백질 활성 상태나 환자 결과와 아무 관련이 없다는 점입니다.
회사의 역상 단백질 배열(RPPA) 기반 단백질 분석은 AKT-mTOR 경로 내에서 단백질 활성화를 측정하여, 유방 종양에서 약물 표적의 발현 및 활성 수준을 동시에 측정하는 상업적으로 사용 가능하고 임상적으로 검증된 유일한 테스트를 제공합니다. 이 접근법은 특정 표적 치료로 혜택을 볼 가능성이 있는 환자들을 보다 정밀하게 식별할 수 있게 합니다.
Ignite Proteomics, une filiale d'IMAC Holdings (Nasdaq: BACK), a publié une étude significative dans le British Journal of Cancer démontrant la supériorité de l'analyse de l'activation des protéines dans la prédiction de la réponse aux thérapies contre le cancer du sein. La recherche révèle que l'évaluation directe de l'activation des protéines fournit une meilleure prédiction des résultats thérapeutiques par rapport au profilage génomique seul.
L'étude a révélé que les patients avec une activation fonctionnelle de l'axe de signalisation AKT-mTOR avaient une réponse moins favorable au traitement standard de première ligne avec des inhibiteurs CDK4/6. Il est important de noter que les mutations génomiques dans les gènes PIK3CA, PTEN ou AKT n'ont montré aucune corrélation avec l'état d'activation des protéines ni avec les résultats des patients.
Le test protéomique de l'entreprise basé sur Reverse Phase Protein Array (RPPA) mesure l'activation des protéines au sein de la voie AKT-mTOR, offrant le seul test cliniquement validé et disponible commercialement qui mesure à la fois les niveaux d'expression et d'activation des cibles médicamenteuses dans les tumeurs mammaires. Cette approche permet une identification plus précise des patients susceptibles de bénéficier de thérapies ciblées spécifiques.
Ignite Proteomics, eine Tochtergesellschaft von IMAC Holdings (Nasdaq: BACK), hat eine bedeutende Studie im British Journal of Cancer veröffentlicht, die die Überlegenheit der Analyse der Proteinaktivierung bei der Vorhersage der Therapieantwort auf Brustkrebs demonstriert. Die Forschung zeigt, dass die direkte Bewertung der Proteinaktivierung eine bessere Vorhersage der therapeutischen Ergebnisse im Vergleich zur alleinigen genomischen Profilierung bietet.
Die Studie ergab, dass Patienten mit funktioneller Aktivierung der AKT-mTOR-Signalachse eine schlechtere Reaktion auf die standardmäßige Erstlinbehandlung mit CDK4/6-Inhibitoren zeigten. Bemerkenswert ist, dass genomische Mutationen in den Genen PIK3CA, PTEN oder AKT keine Korrelation mit dem Status der Proteinaktivierung oder den Ergebnissen der Patienten zeigten.
Der firmeneigene Reverse Phase Protein Array (RPPA)-basierte Proteomtest misst die Proteinaktivierung innerhalb des AKT-mTOR-Wegs und bietet den einzigen kommerziell verfügbaren und klinisch validierten Test, der sowohl die Expression als auch die Aktivierungsniveaus der Medikamentenziele in Brusttumoren misst. Dieser Ansatz ermöglicht eine genauere Identifizierung von Patienten, die von spezifischen zielgerichteten Therapien profitieren könnten.
- Company offers the only commercially available and clinically validated assay for measuring protein activation in breast tumors
- Study demonstrates superior efficacy of protein activation analysis over genomic profiling
- Technology enables more precise identification of effective cancer treatments
- None.
Insights
This pivotal study publication represents a significant milestone for IMAC Holdings' subsidiary Ignite Proteomics, demonstrating clear superiority of their proteomic approach over traditional genomic testing in breast cancer treatment selection. The research validates their Reverse Phase Protein Array (RPPA) technology as the only commercially available and clinically validated assay for measuring both protein expression and activation levels in breast tumors.
The market implications are substantial. The breast cancer diagnostics market is projected to reach
Two key factors make this development particularly valuable:
- The demonstration that patients with activated AKT-mTOR signaling showed worse response to CDK4/6 inhibitor therapy provides a clear clinical use case that could drive adoption among oncologists
- The validation in a real-world cohort strengthens the evidence base needed for insurance coverage and clinical guideline inclusion
For investors, this represents a potential inflection point in IMAC Holdings' trajectory. The company's positioning in the precision oncology space, backed by peer-reviewed validation in a prestigious journal, could accelerate commercial adoption and revenue growth. However, successful market penetration will depend on securing favorable reimbursement policies and effectively competing with entrenched genomic testing providers.
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.com
Website: 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.
FAQ
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