Paxalisib

Recent therapeutic advances from Merck, Kazia Therapeutics, and others offer hope for glioblastoma patients, with small molecules, immunotherapies, and oncolytic viruses showing potential. Kazia's paxalisib and Merck's MOD-246 are notable, while cell and gene therapies like CAR T cells and CorriXR's gene therapy are emerging as next frontiers. Immunotherapies and vaccines are also being developed to target glioblastoma's immunosuppressive effects, with the market expected to grow to $5.7 billion by 2033.

Two-thirds of patients with PI3K-mutant brain metastases responded to paxalisib plus radiation therapy, with 8/12 having intracranial responses. TTFields therapy improved median progression-free survival in glioblastoma from 5.6 to 9.9 months. Proton craniospinal irradiation showed a median overall survival of 13.7 months for leptomeningeal metastases.

DelveInsight's 'Glioblastoma Pipeline Insight, 2024' report details 190+ companies developing 200+ therapies, including Enzastaurin, Marizomib, VT1021, and ONC201, with insights on mechanism of action, route of administration, and market dynamics.

Kazia Therapeutics to discuss paxalisib's registration as treatment for newly diagnosed glioblastoma with the FDA. GBM AGILE trial results show paxalisib improved overall survival in unmethylated glioblastoma patients. Additional trials for brain metastases, diffuse midline gliomas, and primary central nervous system lymphoma are ongoing.

Kazia Therapeutics to meet with FDA in December to discuss paxalisib registration for glioblastoma multiforme. Updated corporate presentation includes GBM AGILE Phase II/III trial data. Kazia plans to attend medical conferences in Q4 2024.

Kazia Therapeutics' November 2024 corporate presentation highlights its late-clinical-stage oncology drug development, focusing on high-quality, differentiated clinical-stage assets. Key assets include the brain-penetrant PI3K/mTOR inhibitor Paxalisib, in trials for various brain cancers, and the selective VEGFR3 inhibitor EVT801, targeting lymphangiogenesis in advanced solid tumors. The company's licensing-driven model and potential non-dilutive income opportunities are also discussed.

Kazia Therapeutics reported a 67% partial response rate with 45mg paxalisib and radiotherapy in a Phase I study for solid tumor brain metastases with PI3K pathway mutations, presented at ASTRO 2024. Over two-thirds of patients at maximum tolerated dose achieved intracranial response, suggesting paxalisib's potential in overcoming tumor radioresistance.

Kazia Therapeutics presented Phase 1 data on EVT801, a VEGFR3 inhibitor, at the 15th Biennial Ovarian Cancer Research Symposium, showing promising activity in high grade serous ovarian cancer.

Kazia Therapeutics (NASDAQ: KZIA) focuses on oncology, with lead drug paxalisib for glioblastoma. Other drugs include EVT801 and Cantrixil. Strategic partnerships and direct offerings fund R&D. Compliance with Nasdaq's Minimum Bid Price Requirement is maintained.