• Promising top-line results warrant focus of the clinical development on NOX-A12 combination therapies in brain cancer
• NOX-A12 + bevacizumab 12-month survival data in glioblastoma expected in April 2023
• Cash runway into June 2023

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 its financial results and business highlights for the six months ending June 30, 2022, and provides an outlook for the rest of the year.

Aram Mangasarian, CEO of TME Pharma commented: "In the last several months, years of focused efforts and commitment to our mission to develop novel therapies for cancer patients have begun to deliver impressive results and it is our bold ambition to change the landscape of treatments for glioblastoma patients, and more broadly patients affected with solid tumors. It has been a transformative period for us in which the announcement of the company’s new name, TME Pharma, officially marked our evolution into an oncology biotech focused on the Tumor Microenvironment – TME. At the same time, we have reported promising and exciting clinical data with our lead asset NOX-A12 in glioblastoma in multiple combination approaches. We are especially encouraged by the results from the combination therapy of NOX-A12 and the anti-VEGF antibody, bevacizumab, that showed reduced tumor size and radiographic partial response in 100% of evaluable patients in June 2022, suggesting an even deeper and more sustained response compared to NOX-A12 alone. This is of particular importance considering the extremely poor response to treatment of patients with MGMT-unmethylated tumors (refractory to chemotherapy) that are incompletely removed by surgery. Updated data will be presented at a scientific conference in November 2022. The development of drugs to treat a difficult and aggressive cancer like glioblastoma is a challenging and lengthy process, and past studies in glioblastoma have shown the difficulty of proving the translation from overall response rate (ORR) to survival. Accordingly, the next phase of NOX-A12’s development will need to focus on overall survival (OS) as well as the durability of responses. Once more mature data on survival, quality of life and neurological function is available, TME Pharma is planning to meet with regulators, which should provide improved visibility on the clinical trial design required to achieve our goal of an approved therapy, and hence the financial needs to move NOX-A12 closer to regulatory approval." 

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.