On April 23, 2024 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), reported 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 (Press release, TME Pharma, APR 23, 2024, View Source [SID1234642262]).
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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 patients 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,1 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.2
"This positive update from the GLORIA trial underlines the exceptional survival achieved by this cohort of patients with measurable tumors after surgery that are resistant to standard of care chemotherapy and gives more support for the potential of this NOX-A12 treatment regimen to prolong survival while preserving quality of life in patients suffering from this aggressive adult brain cancer," said Aram Mangasarian, CEO of TME Pharma. "This latest announcement adds to the significant clinical and regulatory progress we have made in recent months with our lead asset, putting us in an excellent position for our upcoming Phase 2 evaluation and our discussions with potential pharmaceutical and financial partners, as we endeavor to deliver NOX-A12 for the benefit of glioblastoma patients as quickly and efficiently as we can."
TME Pharma recently announced two key regulatory milestones with the clearance by the US Food and Drug Administration (FDA) in March of the company’s Investigational New Drug (IND) application for NOX-A12 in glioblastoma, allowing TME Pharma to 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 US 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.