TME Pharma NV  a biotechnology company specializing in the development of novel therapies for the treatment of cancer by targeting the tumor microenvironment, announces that the American Society of Clinical Oncology (ASCO) has published an abstract disclosing new data on predictive biomarkers from the GLORIA phase 1/2 clinical trial of NOX-A12 in brain cancer (glioblastoma). The data will be presented in poster form at the ASCO Annual Meeting by Dr. Frank A. Giordano, Principal Investigator of the GLORIA trial, on Saturday, June 3, 2023, beginning at 1:15 p.m. CST (8:15 p.m. CEST) in Chicago. , Illinois, USA.

The abstract highlights biomarker analyzes of 10 glioblastoma patients from the GLORIA trial treated with radiotherapy (RT) and NOX-A12. Patients with higher biomarker scores at baseline had significantly longer progression free survival (PFS) than those with lower scores (6.0 vs. 3.0 months; p= 0.031) and a tendency towards prolonged OS ( overall survival, survival rate) (15.8 vs. 11.1 months; p = 0.075). In contrast, these correlations were not observed in the reference cohort of patients treated with standard care (PFS: 4.6 vs. 6.0 months; p = 0.502; OS: 9.6 vs. 10.0 months; p = 0.243).

The fact that there is a correlation with clinical outcomes when NOX-A12 is used, but not with standard treatment, means that this biomarker specifically predicts the response to NOX-A12. These data show superior clinical efficacy of NOX-A12 and RT treatment in patients with a high biomarker score, suggesting that the score can be used as a new predictive biomarker for therapies targeting CXCL12, such as NOX-A12, in glioblastoma.

“We are delighted to announce the presentation of these exceptional new data from the GLORIA trial, which identify a novel biomarker capable of predicting the clinical responses of brain cancer patients to NOX-A12-based therapies,” said Aram . Mangasarian, CEO of TME Pharma. “ Beyond the relevance of the therapeutic choice for the patient, having a predictive biomarker is very positive and could be decisive on several levels if it is validated in future studies. Allfirst, being able to select the patients who will benefit the most from NOX-A12 will increase our chances of obtaining regulatory approval and commercial success, while significantly reducing the risks associated with the clinical development of NOX-A12, which which is important for investors and pharmaceutical partners in hard-to-treat indications such as brain cancer, glioblastoma . Additionally , going forward, it would put NOX-A12 in a much better position for pricing and reimbursement discussions with payers, since we could move forward with a high probability that our therapy will benefit patients. Therepresentation of our latest development of GLORIA at ASCO, one of the most renowned cancer conferences in the world, fully underlines the importance of the results of this trial and the progress made by TME Pharma in the treatment of this complex disease and disabling. »

The biomarker is calculated by analyzing the expression frequency of the NOX-A12 target (CXCL12 or "12") on two types of cells in the tumor microenvironment (TME): 1) blood vessel cells (endothelial or "E ") and 2) cancer cells (gliomas or "G"). The combination of CXCL12 expression on these two key cell types in the TME results in the EG12 score, essentially the fraction of endothelial cells and glioma cells expressing CXCL12. This EG12 score is significantly correlated with PFS (r = 0.87; p = 0.005) in patients treated with NOX-A12 and RT. This correlation was not observed in a reference cohort of 15 patients with glioblastoma and treated with the standard treatment (r=-0.10; p=0.724).

The details of the presentation of the posters presented at ASCO are as follows:

Title: Potential predictive biomarker for response to radiotherapy and CXCL12-inhibition in glioblastoma in the phase 1/2 GLORIA trial, abstract #2048 GLORIA phase 1/2 trial)
Abstract: see the ASCO website
Presenter: Frank A. Giordano, professor and chairman of the radiation oncology department at the University Medical Center in Mannheim, Germany, and principal investigator of the GLORIA trial.
Session type: Poster Session Session
title: Central Nervous System Tumors
Session date and time:June 3, 2023, 1:15-4:15pm CST

The poster will be available on the TME Pharma website on June 3, 2023.

 

Source:tmepharma.com

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