TME Pharma

Glioblastoma Treatment with Irradiation and Olaptesed Pegol (NOX-A12) in MGMT Unmethylated Patients (GLORIA)
(ref: NCT04121455)
Status: recruiting

Glioblastoma multiforme (GBM) is one of the deadliest and most aggressive forms of brain cancer. Patients with this devastating orphan disease are faced with extremely poor prognosis and a staggering 95% of them will not survive beyond 5 years. The standard of care – a combination treatment, including surgery, radiotherapy and chemotherapy – unfortunately is not curative. Moreover, not all patients are eligible or would benefit from chemotherapy, which further limits the efficacy of the treatment. There is a huge unmet need for an effective approach to treat GBM that prevents tumor recurrence. Our approach is built on research and data suggesting that tumor microenvironment (TME) plays a critical role in how effective anti-cancer therapies are at fighting the disease.

GLORIA is Phase 1/2 study in glioblastoma (brain cancer) patients resistant to standard chemotherapy (unmethylated MGMT promoter) consisting of a dose-escalation part with NOX-A12 plus radiotherapy and three additional arms combining NOX-A12 with radiotherapy plus bevacizumab (VEGF inhibitor) or pembrolizumab (PD-1 inhibitor), or NOX-A12 plus radiotherapy in patients with complete tumor resection.

Therapies with NOX-A12 indicate promising and exciting efficacy, and greater clinical benefit over standard of care.

Cohort
Therapy
Tumor size
reduction
Partial Response
(>50% tumor reduction)
Standard of care historical control arm (n=20)1 25% 10%
NOX-A12 + RT
(n=10)1
90% 40%
NOX-A12 + RT + Beva
(n=6)2
100% 100%
(83% mRANO)

1. Giordano (2022) ASCO Annual Meeting Presentation #2050 link
2. Giordano (2022) SNO Annual Meeting Poster Presentation #CTNI-67 link & TME Pharma Press Release 19 November 2022 link
RT = Radiotherapy; Beva = bevacizumab. Standard of care = RT + chemotherapy
 

Results in NOX-A12 + RT + Beva combination generated and reported to date2:

  • All 6 (100%) patients attained radiographic partial responses (PR) of the tumor lesions (>50% shrinkage).
  • 5 of 6 (83%) patients achieved durable PR by mRANO criteria (modified Response Assessment in Neuro-Oncology), which takes into account radiographic response as well as other factors such as clinical condition of the patient.
  • 2 of 6 patients achieved almost complete tumor size reduction (>99%) where contrast enhancing lesions were detectable but too small to be measured.
  • All mRANO partial responders maintained their PR with a median follow-up of 7.9 months.
  • All mRANO partial responders maintained stable neurologic function as assessed by the NANO (Neurologic Assessment in Neuro-Oncology). Other quality of life measurements were stable or improved in the majority of patients.
  • The triple combination was well tolerated and safe. No dose-limiting toxicities were observed.
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