BERLIN--(BUSINESS WIRE)-- Regulatory News:

TME Pharma N.V. (Euronext Growth Paris: ALTME), a biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), 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.

About TME Pharma

TME Pharma is a clinical-stage company focused on developing novel therapies for treatment of the most aggressive cancers. The company’s oncology-focused pipeline is designed to act on the tumor microenvironment (TME) and the cancer immunity cycle by breaking tumor protection barriers against the immune system and blocking tumor repair. By neutralizing chemokines in the TME, TMEPharma’s approach works in combination with other forms of treatment to weaken tumor defenses and enable greater therapeutic impact. In the GLORIA clinical trial, TME Pharma is studying its lead drug candidate NOX-A12 in newly diagnosed brain cancer patients who will not benefit clinically from standard chemotherapy. TME Pharma has delivered top-line data from the NOX-A12 three dose-escalation cohorts combined with radiotherapy of the GLORIA clinical trial, observing consistent tumor reductions and objective tumor responses. Additionally, GLORIA expansion arms evaluate safety and efficacy of NOX-A12 in other combinations where the interim results from the triple combination of NOX-A12, radiotherapy and bevacizumab suggest even deeper and more durable responses. NOX-A12 in combination with radiotherapy has received orphan drug designation for glioblastoma in the United States and glioma in Europe. TME Pharma has delivered final top-line data with encouraging overall survival and safety profile from its NOX-A12 combination trial with Keytruda® in metastatic colorectal and pancreatic cancer patients, which was published in the Journal for ImmunoTherapy of Cancer in October 2021. The company has entered in its second collaboration with MSD/Merck for its Phase 2 study, OPTIMUS, to further evaluate safety and efficacy of NOX-A12 in combination with Merck’s Keytruda® and two different chemotherapy regimens as second-line therapy in patients with metastatic pancreatic cancer. The design of the trial has been approved in France and Spain and is in discussion with regulatory authorities in the United States. The company’s second clinical-stage drug candidate, NOX-E36, is designed to target the innate immune system. TMEPharma is considering several solid tumors for further clinical development. Further information can be found at: www.tmepharma.com.

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About the GLORIA Study

GLORIA (NCT04121455) is TMEPharma’s dose-escalation, Phase 1/2 study of NOX-A12 in combination with radiotherapy in first-line partially resected or unresected glioblastoma (brain cancer) patients with unmethylated MGMT promoter (resistant to standard chemotherapy). GLORIA further evaluates safety and efficacy of NOX-A12 three additional arms combining NOX-A12 with: A. radiotherapy in patients with complete tumor resection; B. radiotherapy and bevacizumab; and C. radiotherapy and pembrolizumab.

About the OPTIMUS Study

OPTIMUS (NCT04901741) is TMEPharma’s planned open-label two-arm Phase 2 study of NOX-A12 combined with pembrolizumab and nanoliposomal irinotecan/5-FU/leucovorin or gemcitabine/nab-paclitaxel in microsatellite-stable metastatic pancreatic cancer patients.

Disclaimer

Translations of any press release into languages other than English are intended solely as a convenience to the non-English-reading audience. The company has attempted to provide an accurate translation of the original text in English, but due to the nuances in translating into another language, slight differences may exist. This press release includes certain disclosures that contain "forward-looking statements.” Forward-looking statements are based on TME Pharma’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, the risks inherent in oncology drug development, including clinical trials and the timing of and TMEPharma’s ability to obtain regulatory approvals for NOX-A12 as well as any other drug candidates. Forward-looking statements contained in this announcement are made as of this date, and TME Pharma undertakes no duty to update such information except as required under applicable law.