Kazia Therapeutics Announces Granting of Type C Meeting with FDA to Discuss Potential Next Steps for Paxalisib in the Treatment of Newly Diagnosed Glioblastoma Multiforme

On November 4, 2024 Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, reported that the U.S. Food and Drug Administration (FDA) has granted a Type C meeting with the Company in December 2024 to discuss the potential pathways to registration of Kazia’s blood brain barrier penetrant PI3K/mTOR inhibitor, paxalisib, for the treatment of patients with newly diagnosed GBM (Press release, Kazia Therapeutics, NOV 4, 2024, View Source [SID1234647676]).

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In July 2024, the Company announced results from the Phase II/III clinical trial, GBM-AGILE, in which newly diagnosed unmethylated patients with glioblastoma treated with paxalisib showed clinically meaningful improvement in a prespecified secondary analysis for overall survival. Full data including secondary endpoints from the paxalisib arm of the GBM-AGILE study is expected to be presented at a scientific meeting later this year.

Paxalisib has previously received orphan drug designation and fast track designation from the FDA for glioblastoma in unmethylated MGMT promoter status patients, following radiation plus temozolomide therapy.

Updated corporate presentation
Today, the Company also announced that it has updated its corporate presentation, which now incorporates preliminary data from the GBM AGILE Phase II/III clinical trial evaluating paxalisib versus the standard of care for the treatment of in patients with glioblastoma. The updated presentation can be found at View Source

Participation in Upcoming and Recent Medical and Investor Conferences

The company plans on attending the following medical conferences in the fourth quarter of 2024:

Society for Neuro-Oncology 29th Annual Meeting and Education Day, November 21-24, 2024, in Houston, TX
San Antonio Breast Cancer Symposium, December 10-13, 2024, in San Antonio, TX
These events provide Kazia with the opportunity to engage with key stakeholders and share the Company’s vision to make a difference in the lives of patients by developing innovative cancer treatments. Kazia looks forward to meeting with investors in person at these events and invites discussion regarding partnering and investment opportunities.

Over the last several months, the Company has also participated and presented at a number of medical and investor conferences, including:

H C Wainwright 26th Annual Global Investment Conference from Sep. 9-11, 2024
15th Biennial AACR (Free AACR Whitepaper) Ovarian Cancer Research Symposium, Sep. 20 – 21, 2024
Oppenheimer Oncology Summit, in collaboration with MD Anderson Cancer Center, Sep. 26, 2024
American Society for Radiation Oncology Annual Meeting, Sep. 29 – Oct. 1, 2024
Deerfield CEO Conference, Oct. 8-9, 2024
Maxim Group’s 2024 Healthcare Virtual Summit, Fireside Chat, Oct. 15, 2024