About Glioblastoma

Glioblastoma (GBM) comprises about 16% of all malignancies of the nervous system and over 50% of all gliomas, and is most common in patients >45 years old. The current standard of care for newly-diagnosed GBM is limited to a combination of surgical debulking followed by concurrent radiotherapy and chemotherapy with temozolomide.

High-grade gliomas (HGG) are either World Health Organization (WHO) grade 3 or grade 4 tumors and tend to grow rapidly and spread faster than tumors of a lower grade. The most common grade 3 tumor is anaplastic astrocytoma and the most common grade 4 tumor is GBM.

The mTOR pathway is frequently over activated in multiple human malignancies including GBM, however oral rapalogs shown poor brain penetration, limiting their potential use for treating GBM. [2] ABI-009 penetrates the blood-brain barrier and high CNS penetration was observed in preclinical studies. [3]

AADi is currently investigating the safety and efficacy of ABI-009 as single agent and in combination with a number of standard and investigational therapies in patients with recurrent HGG and in combination with temozolomide and radiation after surgery in newly diagnosed GBM in a phase 2 study (NCT03463265).

  1. CBTRUS Statistical Report: Primary Brain and CNS Tumors Diagnosed in the US in 2004 – 2008.
  2. O’Reilly et al., Cancer Chemother Pharmacol 65(4): 625-639.
  3. Aadi data on file.