Kazia Therapeutics has released its Q223 activity report and provided a business update for the quarter. Q2 was marked by increased preclinical efforts towards exploring the applicability and efficacy of paxalisib in non-central nervous system (CNS) oncology indications such as melanoma and other solid tumors, including breast cancer. Post-period, Kazia announced a A$4.5m fund-raise through a two-stage private placement of 40.9m new shares (25.4m unconditional shares and 15.5m conditional shares...
Kazia Therapeutics has announced a research collaboration with QIMR Berghofer Medical Research Institute (an Australia-based cancer research center) to investigate the utility of its lead asset, paxalisib (PI3K/mTOR inhibitor) in solid tumors. The collaboration plans to build on previously conducted research, including the potential use of paxalisib as an immune modulator in solid tumors. We note that the company recently announced encouraging data in a preclinical melanoma study, highlighting K...
Kazia Therapeutics has announced the publication of pre-clinical data for its second pipeline asset, EVT801 in the journal Cancer Research Communications. The research was conducted by licensing partner Evotec and was the key driver for Kazia in-licensing the asset in 2021. EVT801 is an inhibitor of vascular endothelial growth factor receptors (VEGFR), which play an important role in angiogenesis and lymphangiogenesis (processes that contribute to tumor growth and metastasis), making VEGFR a wel...
Kazia Therapeutics’ Q123 cash flow report provided an update on the company’s financial position and business progress. While the quarter was dominated by lead asset paxalisib hitting a roadblock (failing to graduate to stage two of the GBM AGILE study), the period was also marked by clinical progress across other serious indications such as pediatric brain cancers and brain metastases (BMs). With multiple studies expected to read-out in CY23, the next few quarters will be crucial for the compan...
Kazia Therapeutics has announced the expansion of the PNOC022 (NCT05009992) trial to two new sites in Australia. The Phase II trial is investigating the combination of ONC201 (a dopamine D2 receptor antagonist) and paxalisib (Kazia’s brain penetrant PI3K inhibitor) in the treatment of diffuse midline glioma (DMG) and diffuse intrinsic pontine glioma (DIPG). Importantly, the PNOC022 trial, which is sponsored by the Pacific Pediatric Neuro-Oncology Consortium, uses an adaptive platform design, mea...
Kazia Therapeutics’ FY22 results recapped a busy year focused on strengthening its oncology-focused pipeline. While the year was marked by encouraging data readouts from several preclinical/clinical programs (particularly in rare childhood brain cancers and brain metastases), this was partially offset by recent news that lead asset paxalisib (PI3K/mTOR inhibitor) has not graduated to Stage 2 of the Phase III GBM AGILE study in glioblastoma multiforme (GBM). Final survival and response data from ...
Kazia Therapeutics has reported that the company’s lead asset paxalisib (PI3K/mTOR inhibitor) has not graduated to Stage 2 of the Phase III GBM AGILE study in glioblastoma multiforme (GBM), as advised by the study sponsors (Global Coalition for Adaptive Research, GCAR). The study is still fully blinded and therefore we cannot draw definitive conclusions from this news. Full survival and response data from GBM AGILE (expected H2 CY23) may still form the basis for FDA approval, however we expect t...
In an encouraging development for Kazia Therapeutics’ efforts towards combating pediatric brain cancers, its lead drug paxalisib has received orphan drug designation (ODD) from the FDA for the treatment of atypical teratoid/rhabdoid tumors (AT/RT). AT/RT is a rare and aggressive childhood brain cancer with a five-year survival rate of c 32%. Approximately 600 people are living with the cancer in the United States, with around 60 new cases reported each year. The ODD accords seven years of market...
In light of the positive newsflow from Kazia’s efforts in addressing adult brain cancer, management is leveraging its niche expertise and experience to address a complex and untapped segment, childhood brain cancer. Due to the challenges in addressing this unmet need, including significant hurdles in enrolling patients for a clinical trial, there is a vacuum of options for those served with this diagnosis. As Kazia is working to pioneer this sub-segment, leveraging its network, in this note we e...
Patient recruitment in the pivotal GBM AGILE study for lead asset paxalisib remains on track, with data expected in CY23, to be followed by a potential regulatory filing, if data are positive. Recent C-suite appointments in the United States suggest an increased focus on commercialization, particularly in the US market. Second asset EVT801 has progressed to human studies, with the first patient enrolled in a Phase I trial in France in November 2021 and interim data expected in H2 CY22. We expect...
Full Article at IIR has reaffirmed its Recommended rating for PIA after undertaking a review post the appointment of a new Portfolio Manager, Harding Loevner. The full report can be found on the IIR website. On 26 July 2021, Pengana International Equities Limited (PIA) announced a fully franked dividend of 1.35 cents per share for the June quarter. This represents an 8% increase on the March quarter dividend and takes the total dividends declared for FY21 of 5.1 cents per share, fully franked....
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