(,) received an increase in Edison Group’s target price share from AU $ 2.83 to AU $ 2.68 per share following the release of interim data for its 30-patient Phase II trial involving on paxalisib in newly diagnosed patients with glioblastoma multiforme (GBM).

Final trial data as well as initial data for paxalisib in the treatment of brain metastases (BM) are expected before the end of this year. In addition, the Phase I trial for EVT801 – a treatment targeting solid tumors – is expected to begin recruitment by the end of the year.

Glioblastoma is the most common and aggressive brain tumor and accounts for about half of all gliomas. According to the United States National Cancer Institute, there are approximately 23,820 cases per year of brain cancer and other cancers of the nervous system in the United States and another 64,600 in Europe, according to the International Center for Research on Cancer. Cancer.

The survival rate of GBM is particularly low with a five-year survival rate of only 5.1% and a median overall survival (OS) of only 10 months.

Kazia has published provisional data on 29 patients in its trial in newly diagnosed GBM patients. The data showed a progression-free survival (PFS) of 8.4 months and OS of 17.5 months.

These results represent an improvement over historical data for PFS and OS for temozolomide, a mainstay of treatment for GBM.

The following excerpts are taken from the Edison Group research report.

Initial incoming data for BM

The Edison Group considers BMs to be one of the most interesting indications for which paxalisib could potentially be used and the drug is being studied for this indication in three clinical studies: one phase I and two phase II, sponsored. by Sloan-Kettering, Alliance Group and Dana. -Farber respectively.

Some initial data from these studies are expected at T4 CY21.

EVT801 Phase I program

EVT801 is an oral small molecule that targets vascular endothelial growth factor receptor 3 (VEGFR3), which Kazia licensed from Evotec in April.

Kazia plans to launch the Phase I program by the end of the year. Phase I will recruit up to 90 patients with advanced solid tumors resistant to existing therapies.

Valuation: AUD 2.83 per basic share

Edison increased its valuation to A $ 375 million or A $ 2.83 per basic share, from A $ 346 million or A $ 2.68 per basic share, mainly due to the carry forward of its net present value ( VAN). This was partially offset by lower net cash and slightly higher expenses.

Kazia reported net cash of AU $ 27.6 million as of June 30, 2021. Edison’s estimated funding requirement for the company is AU $ 60 million (of which A $ 30 million during the fiscal year 23), compared to AU $ 50 million previously due to increased R&D spending.

Paxaslib

Paxalisib is an inhibitor of PI3K and mTOR under investigation in several clinical trials in brain cancer. The drug is in a phase II study in 30 patients with newly diagnosed GBM and an unmethylated MGMT promoter, with final data expected at T4 CY21. Paxalisib is used as an adjuvant after initial resection, radiation therapy, and temozolomide.

Treatment options are limited. Since 2005, only three new treatments have been approved for GBM: temozolomide, bevacizumab and tumor treatment fields. The standard of care for newly diagnosed GBM is a combination of surgery, radiation therapy, and temozolomide with recurrence occurring due to resistance to temozolomide.