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.  ABI-009 penetrates the blood-brain barrier and high CNS penetration was observed in preclinical studies. 
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).
CBTRUS Statistical Report: Primary Brain and CNS Tumors Diagnosed in the US in 2004 – 2008.
O’Reilly et al., Cancer Chemother Pharmacol 65(4): 625-639.