Purple Biotech Announces More Positive Interim Results from CM24 Phase 2 Pancreatic Cancer Study on Predictive Biomarker for Survival Benefit

Recent findings indicate that baseline serum myeloperoxidase (MPO) levels below a certain threshold can predict overall survival (OS) improvement in patients treated with the CM24+nivolumab+Nal-IRI/5FU/LV regimen compared to those receiving only the standard chemotherapy (Nal-IRI/5FU/LV). Data shared at the 2024 ASCO annual meeting highlighted a significant reduction in the risk of death and cancer progression, and an extension of both OS and progression-free survival (PFS) in the CM24+nivolumab+Nal-IRI/5FU/LV treatment group. Additionally, this group showed a higher objective response rate (ORR), disease control rate (DCR), and a decrease in CA19-9 levels.

Purple Biotech Ltd., a clinical-stage company based in Rehovot, Israel, disclosed further positive interim data from a Phase 2 study (NCT 04731467) evaluating CM24 combined with nivolumab and standard chemotherapy in second-line metastatic pancreatic ductal adenocarcinoma (PDAC). The findings suggest serum MPO as a potential predictive biomarker for survival in patients undergoing this combination therapy. The company plans to delve deeper into these results during a virtual key opinion leader (KOL) event scheduled for July 11, 2024.

The interim results, presented on June 1, 2024, at the ASCO Annual Meeting, indicated a 26% reduction in the risk of death (HR=0.74) and a 28% reduction in the risk of progression or death (HR=0.72) in patients treated with the CM24+nivolumab+Nal-IRI/5FU/LV regimen compared to those receiving only the standard chemotherapy. Specifically, the CM24+nivolumab+Nal-IRI/5FU/LV treatment extended median OS by 2.1 months and median PFS by 1.9 months. Furthermore, the inclusion of CM24 and nivolumab significantly improved the ORR (25% vs. 7%), DCR (63% vs. 40%), and resulted in a notable reduction of CA19-9 levels (61% decrease vs. 34% increase).

Gil Efron, Chief Executive Officer of Purple Biotech, emphasized the encouraging improvements in primary and secondary endpoints, such as OS, PFS, ORR, DCR, and CA19-9. Efron also highlighted the potential of serum MPO as a predictive biomarker, reinforcing the efficacy of CM24 in combination with nivolumab and standard chemotherapy in improving clinical outcomes for advanced metastatic PDAC patients. Additional clinical data are anticipated in the latter half of 2024.

The interim biomarker analysis compared the experimental and control groups, indicating that baseline serum MPO could serve as a clinical outcome biomarker for CM24-nivolumab therapy. Elevated MPO levels were observed in over 90% of patients, with mean MPO levels being more than six times higher than those in healthy donors. Notably, patients with serum MPO levels below the mean showed a median OS improvement of 3.6 months.

The experimental arms of the Phase 2 study involved administering CM24 and nivolumab, along with a choice of one of two standard chemotherapies used in second-line PDAC, depending on the prior first-line therapy. The control group received only the standard chemotherapy. The reported interim results pertain to the Nal-IRI/5FU/LV sub-study, with analysis of the gemcitabine/nab-paclitaxel sub-study to follow as data matures.

CM24, a humanized monoclonal antibody, targets CEACAM1, an immune checkpoint protein that facilitates tumor immune evasion and resistance to immune checkpoint inhibitors. CM24's mechanism includes binding to neutrophil extracellular traps (NETs) and significantly reducing NET-induced cancer cell migration. This Phase 2 study follows earlier findings where CM24+nivolumab treatment notably decreased NET markers in patient serum.

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