TME Pharma Announces Final Median Overall Survival Data Reaching 19.9 Months for NOX-A12 Combination Regimen in GLORIA Brain Cancer Trial and Survival Rate 10-Fold Greater Than Standard of Care

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 that the final median overall survival (mOS)¹ for newly diagnosed glioblastoma patients receiving NOX-A12, TME Pharma's CXCL12 inhibitor, with the VEGF inhibitor bevacizumab and radiotherapy in the GLORIA expansion arm has reached 19.9 months.

The mOS achieved by NOX-A12 in combination with radiotherapy and bevacizumab compares very favorably to the matched standard of care reference cohort, which achieved an mOS of 10.5 months, and exceeds what TME Pharma believes to be all relevant competitor therapy trials in newly diagnosed glioblastoma patients resistant to standard chemotherapy.² 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 in the GLORIA trial, while competing trials also included patients with complete removal of the detectable tumor who have a better expected survival outcome.

Based on these data, TME Pharma has submitted an Investigational New Drug (IND)³ application and a Fast-Track Designation⁴ request to the US Food and Drug Administration (FDA) for the use of NOX-A12 in the treatment of aggressive adult brain cancer, glioblastoma. TME Pharma targets approval of the IND and a decision on the Fast-Track Designation by the FDA before the end of March 2024. The goal is to have an FDA-approved clinical trial protocol in glioblastoma with an expedited regulatory path in place in order to maximize chances of securing the necessary funding for the upcoming clinical trial via partnership, investment or other strategic transaction types.

"With the survival data from the GLORIA cohort receiving NOX-A12, bevacizumab and radiotherapy reaching an unprecedented median overall survival of 19.9 months for the population of patients recruited, we see here compelling evidence of the potential of this combination to provide significant survival benefit to patients suffering from aggressive brain cancer over both standard of care and other competing therapies being developed clinically," said Aram Mangasarian, CEO of TME Pharma. "The survival data formed a key part of our regulatory interactions, and following our recent constructive advice meeting with the FDA we are confident of being able to achieve our target of an approved IND and a decision on a Fast-Track Designation for NOX-A12 by the end of Q1 2024. We believe the strong clinical data produced by the GLORIA trial along with a clear regulatory roadmap will allow us to attract the right partner and financing for NOX-A12 to achieve its potential to become the best available therapy for glioblastoma patients."