TME Pharma announces further improvement in median overall survival at 19 months follow-up in GLORIA brain cancer trial

• Median overall survival surpasses 19 months and continues to improve in glioblastoma patients receiving NOX-A12 combination with radiotherapy and bevacizumab
• Survival rate in this cohort at 19 months is 10-fold greater than a reference cohort of matched patients receiving standard of care (50% vs. 5%)

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 that with median overall survival (mOS) has now passed 19 months and will improve further in the GLORIA expansion arm for newly diagnosed glioblastoma patients receiving NOX-A12 with the VEGF inhibitor bevacizumab and radiotherapy.

“The survival data in the cohort receiving the combination of NOX-A12, bevacizumab and radiotherapy has continued to improve with treatment or follow-up of enrolled brain cancer patients. Passing 19 months suggests a large survival benefit for patients on NOX-A12-based therapy since we are seeing more than an 80% increase in survival over the 10.5 months in the matched standard of care reference cohort of patients with the same profile as those we recruited into the study of NOX-A12: newly‑diagnosed aggressive brain cancer (glioblastoma) with chemotherapy refractory tumors not amenable to complete surgical resection," said Aram Mangasarian, CEO of TME Pharma. "With further perspective on the data we can now say with certainty that median overall survival will be between 19.0 and 19.9 months and plan to provide an update before the end of February 2024.”

The NOX-A12-based combination with bevacizumab and radiotherapy has now further surpassed the median overall survival figures achieved in what TME Pharma believes to be all the relevant competitor studies conducted in the US or EU involving newly diagnosed, chemotherapy-resistant (MGMT unmethylated) glioblastoma patients which ranged from 13.4 to 16.5 months mOS for therapies in clinical development and 16.9 months demonstrated by the Tumor Treating Fields device that was approved by the US Food and Drug Administration (FDA) for newly-diagnosed glioblastoma in 2015[1]. In addition, the NOX‑A12-based therapy achieved this result despite having a more difficult population to treat since only patients with residual detectable tumor after surgery were included the NOX-A12 trial, while competing trials included patients with complete removal of detectable tumor.

¹See annex to the TME Pharma press release published on 13 September 2023 

About the GLORIA Study

GLORIA (NCT04121455) is TME Pharma’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 TME Pharma’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 TME Pharma’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.