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Ignite Proteomics presents data on MHC-II as predictor of pembrolizumab response
Ignite Proteomics announced the presentation of new data demonstrating that MHC-II protein expression is a superior predictor of response to pembrolizumab compared to PD-L1 at the upcoming National Comprehensive Cancer Network Annual Conference. The study, conducted with I-SPY 2 clinical trial results, evaluated five different PD-L1 antibodies - including the one most commonly used as a companion diagnostic - yet only MHC-II expression showed a statistically significant correlation with patient outcomes. I-SPY 2 is a multicenter, adaptive platform trial primarily focused on high-risk stage II and III breast cancer patients undergoing neoadjuvant treatment. The design rapidly evaluates new agents - such as checkpoint inhibitors - based on interim outcomes like pathologic complete response. Data from I-SPY 2 often guides further clinical development in breast cancer, underscoring the significance of MHC-II outperforming PD-L1 measurements in this well-regarded research setting. Five PD-L1 Antibodies Tested: Only MHC-II correlated with response to pembrolizumab, whereas none of the five PD-L1 measurements reached statistical significance. Improved Patient Outcomes: Patients with higher MHC-II protein levels demonstrated nearly double the response rate compared to the unselected patient cohort. Unmet Need in Some Indications: For some cancers and settings where no biomarker testing is used, a large fraction of patients do not respond to checkpoint inhibitors. This study suggests MHC-II testing can enrich for those more likely to benefit.
IMAC Holdings receives Nasdaq notification of deficiency
IMAC Holdings announced that it received an expected deficiency notification letter from the Listing Qualifications Staff of The Nasdaq Stock Market LLC on November 22, 2024. The Notice indicated that the company was not in compliance with Nasdaq Listing Rule 5250(c)(1) as a result of its failure to timely file its Quarterly Report on Form 10-Q for the period ended September 30, 2024, as described more fully in the Company's Form 12b-25 Notification of Late Filing filed with the Securities and Exchange Commission on November 15, 2024. The Listing Rule requires Nasdaq-listed companies to timely file all required periodic reports with the SEC. The company continues to work diligently to file the Form 10-Q as soon as practicable. The Notice has no immediate effect on the listing or trading of the company's common stock on the Nasdaq Capital Market.
IMAC Holdings granted extension by Nasdaq to regain compliance
IMAC announced that it has received an exception from the Listing Qualifications Staff of The Nasdaq Stock Market to regain compliance with Nasdaq Listing Rule 5250(c)(1). This exception extends the deadline for the Company to file its Quarterly Report on Form 10-Q for the period ended June 30, 2024 until February 17, 2025. The delay in filing is primarily due to complexities in preparing the company's financial statements for the second quarter as a result of events occurring during the period ended June 30, 2024 and certain staffing challenges, including, among other things: Acquisition of Assets; Securities Exchange; Staff Challenges.
IMAC Holdings launches Ignite Proteomics subsidiary
IMAC Holdings announces the launch of an entirely new precision oncology assay for breast cancer treatment decision making utilizing the Reverse Phase Protein Array technology through its newly established subsidiary, Ignite Proteomics. This launch follows IMAC Holdings' strategic acquisition of key assets from Theralink Technologies, Inc., and is underscored by a landmark clinical case study "Proteomics based selection achieves complete response to HER2 therapy in HER2 IHC 0 breast cancer", demonstrating the power of RPPA technology in precision oncology published in npj Precision Oncology, an international, peer-reviewed journal focused on precision oncology. Ignite Proteomics introduces the only commercialy available and clinically validated assay that can measure both the expression and activated protein drug target levels in breast tumors, a superior way to measure the potential effectiveness of targeted cancer therapies. The clinical utility of the Ignite proteomic assay is highlighted by this recent case study involving a 57-year-old woman with metastatic triple-negative breast cancer who exhibited an exceptional response to treatment guided by Ignite's RPPA-based analysis. Despite previous extensive treatments including chemotherapy and targeted therapies, the patient experienced disease progression across multiple sites. A clinical trial at the Inova Schar Cancer Institute allowed for a comparative analysis using both current next-generation sequencing assays and Ignite's novel assay on the same biopsy. After Ignite Proteomics RPPA assay identifed the expression and activation of an important protein called HER2, which was missed by both the NGS analysis and current approaches to measure HER2 the patient was treated with the antibody-drug conjugate trastuzumab deruxtecan, which relies on HER2 expression and activation to work. After 9 cycles no measurable disease was observed, representing a complete response to therapy.
IMAC Holdings receives noncompliance notification from Nasdaq
IMAC Holdings announced that it received an expected deficiency notification letter from Nasdaq on August 21. The notice indicated that the company was not in compliance with Nasdaq Listing Rule 5250 as a result of its failure to timely file its Quarterly Report on Form 10-Q for the period ended June 30, as described more fully in the company's Form 12b-25 notification of late filing filed with the SEC on August 15. The listing rule requires Nasdaq-listed companies to timely file all required periodic reports with the SEC.
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