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Purple Biotech Reports Positive NT219 Data at AACR for Colorectal and Head and Neck Cancers

Core Viewpoint - Purple Biotech Ltd. is advancing its clinical-stage therapy NT219, which targets tumor immune evasion and drug resistance, with promising data presented at the AACR 2025 Annual Meeting [1][3][10] Group 1: NT219 Overview - NT219 is a novel dual inhibitor of IRS1/2 and STAT3, currently in a Phase 2 study for recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC) in combination with pembrolizumab and cetuximab [2][10] - The mechanism of NT219 involves suppression of STAT3 and degradation of IRS1/2, which blocks IGF1R/IRS and downstream AKT and β-catenin signaling pathways [3][7] Group 2: Clinical Data and Biomarkers - Significant upregulation of STAT3, IRS1/2, and β-catenin was observed in HNSCC tumors compared to normal tissues, indicating potential biomarkers for NT219-based therapy [3][7] - The data suggest that activated forms of STAT3 and IGF1R correlate with patient response to NT219 treatment, supporting their role as potential biomarkers [7][12] Group 3: Efficacy in Colorectal Cancer - NT219 has shown anti-tumor efficacy in colorectal cancer (CRC) models, with APC-loss and activated β-catenin identified as potential biomarkers for treatment response [5][12] - The therapy has demonstrated the ability to reverse chemo-resistance and enhance the efficacy of existing chemotherapy regimens [12] Group 4: Future Directions - The findings from the AACR meeting are expected to guide study design, patient selection, and combination therapy strategies for NT219 [3][7] - Purple Biotech is committed to advancing NT219 in collaboration with the University of Colorado for R/M HNSCC patients [10]