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Purple Biotech Unveils Promising Biomarker for Cancer Therapy

AInvestTuesday, Nov 5, 2024 8:17 am ET
2min read
Purple Biotech, a clinical-stage company specializing in first-in-class therapies, has recently announced promising results from a Phase 2 study of its lead candidate, CM24, in combination with Bristol Myers Squibb's immune checkpoint inhibitor nivolumab and standard-of-care chemotherapy for metastatic pancreatic ductal adenocarcinoma (PDAC). The interim data, presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, demonstrated a 26% reduction in risk of death and a 28% risk reduction in progression or death in previously-treated patients administered with CM24+nivolumab+Nal/IRI/5FU/LV versus standard-of-care (SoC) based on preliminary interim data. The data also showed a prolongation of 2.1 months in median overall survival (OS) and 1.9 months in median progression-free survival (PFS) in the CM24+nivolumab+Nal-IRI/5FU/LV regimen versus SoC.

The study, evaluating CM24 in combination with nivolumab and SoC chemotherapy in second-line PDAC patients versus SoC chemotherapy alone, used a Bayesian methodology to estimate the magnitude of effect of the experimental arm versus the SoC arm. The primary endpoint of the study was OS, and the secondary endpoints included PFS, ORR, and DCR. A total of 63 patients have been enrolled across 18 centers in the U.S., Spain, and Israel in 2 parallel independent randomized study cohorts. The experimental arms administered patients with CM24 plus nivolumab and a choice of one of two SoC chemotherapies for second-line PDAC, dependent on prior first-line therapy regimen; either gemcitabine/nab-paclitaxel or liposomal irinotecan (Nal-IRI)/5-fluorouracil (5-FU) and leucovorin (LV) (Nal-IRI/5FU/LV), while the control arms administered either respective chemotherapy alone. CA19-9, as well as additional exploratory biomarkers, are also being evaluated.


In addition to the positive interim data, Purple Biotech also reported the identification of a potential predictive biomarker for overall survival benefit. Baseline serum myeloperoxidase (MPO) levels below a specific threshold may predict improved OS when comparing the CM24+nivolumab+Nal-IRI/5FU/LV versus Nal-IRI/5FU/LV arms. These findings suggest that serum MPO may serve as a potential clinical outcome biomarker for CM24-nivolumab therapy.


The concordant and consistent improvement in primary and all secondary endpoints, including OS, PFS, ORR, DCR, and CA19-9, are compelling. The addition of a potential predictive biomarker further supports the potential of CM24 in combination with nivolumab plus the SoC chemotherapy regimen Nal-IRI/5FU/LV to improve clinical outcomes for those with advanced metastatic PDAC. Purple Biotech plans to report further clinical study data in the second half of 2024.

As an investor, these developments highlight the potential of Purple Biotech's CM24 therapy in the treatment of metastatic PDAC. The positive interim data and the identification of a potential predictive biomarker suggest that CM24 may offer significant clinical benefits for patients. Moreover, the company's strategic partnerships with Bristol Myers Squibb and its focus on first-in-class therapies position it well for future growth and success in the biotechnology sector.

In conclusion, Purple Biotech's recent findings in its Phase 2 study of CM24 therapy, along with the identification of a potential predictive biomarker, underscore the company's commitment to developing innovative cancer therapies. As an investor, keeping an eye on Purple Biotech's progress and potential could prove to be a lucrative opportunity in the biotechnology sector.
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