TME Pharma Announces Positive 15-month Survival Data From GLORIA Expansion Arm Evaluating NOX-A12 in Combination With Radiotherapy and Bevacizumab in Glioblastoma

• 83% of glioblastoma patients remain alive after 15 months on study, unchanged from the 14-month survival update
• 15-month mark further surpasses the expected survival in patients resistant to chemotherapy with incomplete surgical tumor removal
• Survival data will improve further as time progresses and patients remain on study
• Continued strong performance improves NOX-A12 profile for partnering and eligibility for accelerated regulatory pathways

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 a positive clinical update on the survival of first-line glioblastoma patients in the GLORIA expansion arm evaluating NOX-A12, TME Pharma’s CXCL12 inhibitor, in combination with standard of care radiotherapy and anti-VEGF, bevacizumab.

After 15 months on study (median), 83% of GLORIA expansion arm patients (5 of 6) remain alive. As long as treatment or follow-up for these patients is ongoing, median overall survival (mOS) will continue to improve¹. As a reference, the expected median overall survival for patients under current standard of care with chemotherapy refractory tumors (MGMT unmethylated) and whose tumor remains detectable after surgical intervention is approximately 10 months².

"Reaching the 15-month survival point with this expansion arm is a significant milestone in our development of NOX-A12 in glioblastoma, and to do so with more than 80 percent of patients still on study represents a fantastic achievement," said Aram Mangasarian, CEO of TME Pharma. "This latest set of survival data further underlines the clinically meaningful improvement that this treatment combination of NOX-A12, radiotherapy and bevacizumab could bring over the current standard of care for this challenging indication with extremely poor prognosis. We are building an enviable clinical profile around our lead asset in glioblastoma, which strengthens NOX-A12’s position for potential partnering and our coming discussions with regulators regarding the pathway to market."

¹In a clinical study, measuring the median overall survival (mOS) is one way to assess how well a new treatment works. The longer the patients remain alive, the longer it takes to reach mOS. mOS can only be calculated when more than half of patients in the study decease.
²Kreth 2013, Annals of Oncology 24:3117. Rounded up from mOS 9.7 months reported in patients with incomplete resection, without MGMT promoter methylation who received standard of care (radiotherapy +/- chemotherapy).

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.