Purple Biotech Reports Final Data from Phase 2 Study of CM24 in Pancreatic Cancer Patients at AACR 2025 Annual Meeting: Improved Outcomes and Significant Efficacy in Biomarker-Enriched Subgroups

Core Viewpoint - Purple Biotech Ltd. announced promising results from a Phase 2 study of CM24 in combination with nivolumab and chemotherapy for pancreatic cancer, highlighting significant survival benefits and the potential for biomarker-driven studies [1][2][3]. Study Findings - The combination therapy was well tolerated and showed improvements in overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR) in previously treated pancreatic ductal adenocarcinoma (PDAC) patients [3][5][6]. - A 90% reduction in risk of death and an 81% reduction in risk of progression or death were observed in patients with high tumor CEACAM1 and low PD-L1 combined positive score [4][9]. - The study identified serum CEACAM1 and myeloperoxidase (MPO) as potential predictive biomarkers for CM24-based therapy, suggesting a multifaceted mechanism of action [9][10]. Efficacy Parameters - The experimental arm demonstrated a 2.4-month prolongation in OS and a 1.9-month prolongation in PFS compared to the control arm [5][8]. - The ORR was higher in the experimental arm at 25% compared to 6.7% in the control arm, and the DCR was 62.5% versus 46.7% [5][6]. - Continuous decrease in CA19-9 levels was observed in the experimental arm, indicating a positive treatment response [5][6]. Future Directions - The next Phase 2b study is expected to include an additional group testing CM24 alone, with patient selection based on identified biomarkers, potentially expanding to other cancer indications [7][8]. - The findings from this study may guide the treatment of patients who are more likely to benefit from CM24 therapy, enhancing the understanding of CEACAM1 and its role in cancer biology [6][9]. Company Overview - Purple Biotech Ltd. is focused on developing first-in-class therapies to overcome tumor immune evasion and drug resistance, with a pipeline that includes CM24, NT219, and CAPTN-3 [8][10].