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 or pembrolizumab, or NOX-A12 plus radiotherapy in patients with complete tumor resection.

Results generated and reported to date indicate:

Promising and exciting efficacy data in NOX-A12 monotherapy + radiotherapy, and in combination with bevacizumab

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=5)2
100% 100%

1. Giordano (2022) ASCO Annual Meeting Presentation #2050 link
2. TME Pharma Press Release 23 June 2022 link
RT = Radiotherapy; Beva = bevacizumab. Standard of care = RT + chemotherapy
 
  • Good safety and tolerability profile of all combinations
  • Tissue analysis confirms mode(s) of action:
    • NOX-A12 target, CXCL12, stripped from blood vessel walls in tumor tissue
    • Increased proportion of activated and proliferating cytotoxic T cells as well as T cell cluster formation
    • Substantial improvement of anti/pro-cancer macrophage ratio

 

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