TME Pharma N.V. announced a positive update on survival at two years for newly diagnosed glioblastoma patients receiving NOX-A12, TME Pharma's CXCL12 inhibitor, with the VEGF inhibitor bevacizumab and radiotherapy. Two out of the six glioblastoma patients in this expansion arm of the GLORIA Phase 1/2 trial have survived for more than 24 months since the start of therapy. These two patibents had tumors which, at one point during treatment, either disappeared completely or reached near-complete reduction (>99%) in size.

The first patient to cross the two-year survival milestone had maintained a physical and cognitive condition within the norm, displaying only minimal disease-specific symptoms at this timepoint. This translates to a preserved quality of life, as evidenced by the patient?s continued ability to engage in hobbies, leisure activities, and social interaction. The second patient?s clinical status at the last assessment at 23 months was stable, although certain neurological functions had been partially affected.

This patient?s course is also remarkable in that they received no therapy expected to prolong survival in the last 18 months since they decided to end treatment with the NOX-A12 combination following a near-complete reduction of tumor as assessed by MRI. In February, TME Pharma announced the final median overall survival (mOS) for this NOX-A12 cohort had reached an unprecedented 19.9 months. This survival rate compares very favorably to a matched standard of care reference cohort, which achieved an mOS of approximately 10 months, and exceeds what TME Pharma believes to be all relevant competitor therapy trials in newly diagnosed glioblastoma patients resistant to standard chemotherapy.

TME Pharma recently announced two key regulatory milestones with the clearance by the U.S Food and Drug Administration (FDA) in March of the company's Investigational New Drug (IND) application for NOX-A12 in glioblastoma, allowing TME Pharmato proceed with the continued clinical development of NOX-A12 in a new Phase 2 study. This was followed by the FDA's award of Fast Track designation to NOX-A12 in glioblastoma in April. Fast Track designation aims to facilitate the development of therapies intended to treat serious conditions and address unmet medical needs, and could support an accelerated pathway to U.S regulatory approval.

Preparatory steps for the NOX-A12 Phase 2 in glioblastoma are ongoing, and TME Pharma is aiming to initiate the new study as soon as the necessary resources from financial and industrial partners have been secured.