TME Pharma N.V. (Euronext Growth Paris: ALTME) has announced promising clinical results for its lead drug candidate, NOX-A12, in the treatment of glioblastoma. The latest data analysis from the GLORIA clinical trial, presented at ESMO 2024, revealed a statistically significant survival benefit for patients receiving NOX-A12 in combination with bevacizumab and radiotherapy, compared to both the standard of care and NOX-A12 combined with radiotherapy alone.
GLORIA Trial Results
The GLORIA trial, a Phase 1/2 study, evaluated NOX-A12 in newly diagnosed glioblastoma patients with tumors resistant to standard chemotherapy and incomplete surgical resection. These patients typically face a poor prognosis. The study achieved a median overall survival (mOS) of 19.9 months for patients receiving the triple combination therapy, doubling the 9.5-month mOS observed in a matched standard of care reference cohort. According to Dr. Frank Giordano, the lead investigator, this improvement was statistically significant compared to both the standard of care and the NOX-A12 plus radiotherapy arm.
Competitive Landscape and Clinical Significance
TME Pharma believes the survival results from the NOX-A12 trial surpass those of other relevant therapy trials in newly diagnosed glioblastoma patients resistant to standard chemotherapy. Notably, the GLORIA trial enrolled patients with a worse prognosis, as it only included patients with residual detectable tumor after surgery, whereas competitor trials also included patients with no detectable tumor after surgery.
Regulatory Milestones and Path to Phase 2
TME Pharma has secured key regulatory milestones for NOX-A12, including FDA clearance of its Investigational New Drug (IND) application and Fast Track designation. The FDA's decision was based on the protocol for a randomized, controlled Phase 2 clinical trial in glioblastoma. Furthermore, the protocol has also been approved in Germany, allowing the company to conduct the Phase 2 study there as well. The Fast Track designation is expected to expedite the development and review of NOX-A12, potentially accelerating its path to market.
Biomarker Discovery
Data from the GLORIA study was published in Nature Communications, highlighting the discovery of a potential predictive biomarker, the “EG12 score.” This score, based on the presence of NOX-A12’s target (CXCL12) in tumor tissue, can predict the success of treatment with NOX-A12 and radiotherapy in glioblastoma patients. Patients with higher biomarker scores demonstrated superior clinical efficacy when treated with NOX-A12 and radiotherapy.
Financial Status and Outlook
TME Pharma reported a net loss for H1 2024 that decreased by 11% compared to the prior year period. The company raised €5 million (gross) through multiple financial transactions in the first half of 2024. As of June 30, 2024, TME Pharma had cash and cash equivalents of €2.7 million, providing financial visibility into January 2025. The company is actively engaged in discussions with potential strategic industrial partners and governmental institutions to out-license NOX-A12 and secure non-dilutive support for the upcoming Phase 2 clinical trial.
Future Plans for NOX-E36
In addition to NOX-A12, TME Pharma is also exploring external development opportunities for NOX-E36, a second clinical-stage asset with potential in ophthalmologic indications. The company believes that NOX-E36's anti-fibrotic properties make it applicable to a large number of eye conditions, including glaucoma surgery, diabetic retinopathy, and age-related macular degeneration.
