On June 26, 2023 Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development company, reported an update on key corporate and clinical initiatives and release a new investor presentation (Press release, Kazia Therapeutics, JUN 26, 2023, View Source [SID1234632897]).
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Key points
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Dr John Friend completes transition into the CEO role, including a full portfolio review.
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Final data anticipated from GBM AGILE pivotal study of paxalisib in glioblastoma in 2H CY2023.
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Interim data from phase II Pacific Pediatric NeuroOncology Consortium study in diffuse intrinsic pontine glioma (DIPG) and other diffuse midline gliomas (DMGs) now expected to be available in July or August 2023.
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Phase I expansion cohort is enrolling for brain metastases study sponsored by Memorial Sloan Kettering Cancer Center. Two other preeminent cancer centres have joined the study. Preliminary data from expansion cohort is anticipated by 1Q24.
Following his appointment as CEO on 1 May 2023, Dr John Friend has completed his transition into the role. He commented, "In the weeks since my appointment, I’ve worked with the team to review the full set of assets and clinical trials within the Kazia portfolio and the process has strongly reinforced my conviction in the opportunities ahead of us."
"We believe substantial potential exists across our pipeline and in particular, across three key pillars of development for paxalisib—adult brain cancer, paediatric brain cancer and brain metastases. We are keen to explore paxalisib’s use in patient populations that may have the greatest benefit from a PI3K/AKT/mTOR targeted therapeutic candidate."
"As we move toward the second half of 2023, critical milestones are approaching for both paxalisib and EVT-801. We look forward to keeping investors updated across our progress on these important programs."
Clinical programs update
11 clinical trials are currently in progress or in planning for Kazia’s two assets, paxalisib and EVT-801, and Kazia continues to execute across all programs. Current program highlights are set out in brief below. Refer to the appended corporate presentation for more detail:
Paxalisib
Kazia’s lead program is paxalisib, an investigational brain-penetrant inhibitor of the PI3K / Akt / mTOR pathway, which is being developed to treat multiple forms of brain cancer. Licensed from Genentech in late 2016, paxalisib is or has been the subject of ten clinical trials in various brain cancers.
GBM AGILE Pivotal study
Final data are expected from the GBM AGILE pivotal study of paxalisib in glioblastoma in 2H CY2023. Depending on the results of the study, Kazia may use such data to support submission of a new drug application for marketing authorisation to the FDA.
PNOC022 phase II study
Paxalisib is being studied as an investigational drug for the treatment of the paediatric brain cancers DIPG and other DMGs in a study sponsored by the Pacific Pediatric Neuro-Oncology Consortium (PNOC).
The study team at PNOC has been diligently collecting and preparing the data for interim analysis. At this point, Kazia expects that the data will be available in July or August 2023.
LUMOS2 phase II study
On 8 June 2023, Kazia announced that it is supporting the University of Sydney on a molecularly-guided phase II clinical study evaluating paxalisib in adult patients with recurrent/progressive isocitrate dehydrogenase (IDH) mutant grade 2 and 3 gliomas (G2/3 gliomas).
The study, named LUMOS2, will be sponsored by the University of Sydney, and coordinated by NHMRC Clinical Trials Centre, University of Sydney, in collaboration with COGNO (CoOperative Trials Group for Neuro-Oncology). LUMOS2, an umbrella study with multiple arms, is expected to enroll up to 76 patients and will be a multi-centre study at several Australian sites, with the potential to expand internationally. We anticipate enrollment to commence in 4Q23.
MSKCC phase I clinical study
Paxalisib is the subject of an ongoing phase I clinical study in combination with radiotherapy for the treatment of brain metastases, sponsored by Memorial Sloan Kettering Cancer Center in New York, NY.
Kazia is pleased to confirm that the phase I expansion cohort is enrolling. Two world-renowned cancer centres have joined MSKCC in this study: Miami Cancer Institute and Fred Hutch Cancer Center in Seattle, WA. Preliminary data from the expansion cohort is anticipated by 1Q24.
EVT-801
Phase I study
Kazia is also developing EVT801, a small-molecule inhibitor of VEGFR3, which was licensed from Evotec SE in April 2021. Preclinical data showed EVT801 to be active against a broad range of tumour types and has shown evidence of synergy with immuno-oncology agents. A phase I study commenced recruitment in November 2021.
EVT-801 continues to enroll in the phase I dose finding study. Kazia anticipates stage 1 data in 2H23, which we believe will enable identification of the recommended dose for subsequent phase II trials. Kazia also anticipates reporting preliminary biomarker data focused on high-grade, serous ovarian cancer as part of this data update.