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     201  0 Kommentare TME Pharma Announces Publication in Nature Communications of Biomarker Data From NOX-A12 Gloria Phase 1/2 Trial in Glioblastoma

    Regulatory News:

    TME Pharma N.V. (Euronext Growth Paris: ALTME), a clinical-stage biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), announces the publication of biomarker data from the GLORIA Phase 1/2 clinical trial of NOX-A12 in brain cancer (glioblastoma) in the peer-reviewed scientific journal Nature Communications.

    The article by Dr. Frank A. Giordano at the University Medical Center Mannheim and members of the five other centers in Germany led by a translational research team at the University of Bonn, entitled "L-RNA aptamer-based CXCL12 inhibition combined with radiotherapy in newly-diagnosed glioblastoma: dose escalation of the phase I/II GLORIA trial", details a potential predictive biomarker known as the "EG12 score" for glioblastoma patients treated with NOX-A12 and radiotherapy.

    The EG12 score is calculated by analyzing the frequency of positivity for NOX-A12’s target, CXCL12, on two key cell types in the glioblastoma tumor microenvironment: endothelial (E) and glioma (G) cells. The score significantly correlated with the clinical outcome, in terms of progression-free survival (PFS) for patients treated with NOX-A12 and radiotherapy (r = 0.87; p = 0.005), but not for a cohort of reference patients with comparable characteristics treated with standard of care (r = 0.13; p = 0.56). As such, the biomarker appears to be specific for response to NOX-A12-based therapies. When dividing the trial population into two groups in the middle by its EG12 score, GLORIA patients with higher EG12 scores had a significantly longer median PFS than those with lower scores (6.0 vs. 3.0 months; p = 0.031) and also a strong trend towards improved median overall survival (15.8 vs. 11.1 months; p = 0.075).

    The research on the EG12 predictive biomarker published in Nature Communications builds on data first presented at the ASCO Annual Meeting in June 2023.

    "The publication of this scientific article in the prestigious peer-reviewed journal Nature Communications is a validation of the groundbreaking biomarker data from our GLORIA trial in aggressive adult brain cancer and builds on the earlier presentation of these findings at one of the world's top cancer conferences," said Aram Mangasarian, CEO of TME Pharma. "A predictive biomarker has many potential advantages, not the least the ability to select patients who will most benefit from our NOX-A12-based therapies. This could help us identify target populations for future clinical trials, enhancing their statistical power and de-risking the further overall clinical development of NOX-A12. It also offers investors and potential partners peer-reviewed evidence of the potential of our glioblastoma program to bring benefit to patients suffering from this complex and underserved indication as we advance NOX-A12 toward Phase 2 evaluation."

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    TME Pharma Announces Publication in Nature Communications of Biomarker Data From NOX-A12 Gloria Phase 1/2 Trial in Glioblastoma Regulatory News: TME Pharma N.V. (Euronext Growth Paris: ALTME), a clinical-stage biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), announces the publication of …