ME Pharma N.V.  a biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment , announces the American Society of Clinical Oncology (ASCO) has published an abstract disclosing new predictive biomarker data from the GLORIA Phase 1/2 clinical trial of NOX-A12 in brain cancer (glioblastoma). The data will be presented in a poster presentation at the ASCO Annual Meeting by Dr. Frank A. Giordano, the lead investigator of the GLORIA trial, on Saturday June 3, 2023, starting at 01:15 p.m. CST (08:15 p.m. CEST) in Chicago, Illinois, US.

The abstract highlights biomarker analyses of 10 glioblastoma patients from the GLORIA trial treated with radiotherapy (RT) and NOX-A12. The patients with higher biomarker scores at baseline had a significantly longer PFS than those with lower scores (6.0 vs. 3.0 months; p = 0.031) and a trend towards prolonged OS (15.8 vs. 11.1 months; p = 0.075). In contrast, these correlations were not seen in the reference cohort patients treated with standard of 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 to clinical outcomes when NOX-A12 is used but not with standard of care means that this biomarker specifically predicts response to NOX-A12. These data show superior clinical efficacy of the NOX-A12 and RT treatment in patients with a high biomarker score, suggesting the score can be used as a novel predictive biomarker for CXCL12-directed therapies, like NOX-A12, in glioblastoma.

"We are thrilled to announce these groundbreaking new data from the GLORIA trial, which identify a new biomarker that can predict 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 validated in future studies. First, having the ability to select patients who will benefit most from NOX-A12 will increase our chances of achieving regulatory approval and commercial success, while at the same time substantially de-risking the clinical development of NOX-A12, which is important for investors and pharma partners in difficult to treat indications like the brain cancer, glioblastoma. Further, in the future, it would give NOX-A12 a significantly improved position for pricing and reimbursement discussions with payers, since we could say with high likelihood that our therapy will benefit patients. Sharing our latest development from GLORIA at ASCO, one of the most renowned cancer conferences in the world, further highlights the significance of the results emerging from this trial and the progress TME Pharma is making in the treatment of this very complicated and debilitating disease."

The biomarker is calculated by analyzing the frequency of expression of the target of NOX-A12 (CXCL12, or “12”) on two types of cells in the tumor microenvironment (TME): 1) blood vessels (endothelial or “E”) cells and 2) cancer (glioma or “G”) cells. Combining CXCL12 expression on these two key cell types in the TME give the EG12 score, essentially the fraction of endothelial 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 seen in a reference cohort of 15 glioblastoma patients treated with standard of care (SOC) (r = -0.10; p = 0.724).

Details of the poster presentation 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)
Abstract: view on the ASCO website
Presenter: Dr. Frank A. Giordano, Professor and Chair of the Department of Radiation Oncology at the University Medical Center Mannheim, Germany, and the lead investigator of the GLORIA trial.
Session Type: Poster Session
Session Title: Central Nervous System Tumors
Session Date and Time: June 3, 2023, 01:15-04:15pm CST

The poster will be made available on the TME Pharma website on June 03, 2023.

 

Source:tmepharma.com

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