Kazia Therapeutics Shows Promising Results with Paxalisib

Exciting Developments from Kazia Therapeutics

Kazia Therapeutics Limited (NASDAQ: KZIA), a leader in oncology drug development, has recently unveiled compelling results from a significant study. The research, helmed by esteemed Professor Sudha Rao at QIMR Berghofer, focuses on the implications of their investigational drug, Paxalisib, in treating Stage IV HER2-positive breast cancer.

Significant Findings in Cancer Research

In an innovative ex vivo study, blood samples were collected from patients battling Stage IV HER2-positive metastatic breast cancer (mBC). The research sought to analyze the effectiveness of Paxalisib, which is a PI3K–mTOR inhibitor, on reducing the metastatic load. The findings revealed that Paxalisib monotherapy not only significantly decreased single circulating tumor cells but also achieved a remarkable 100% disruption of circulating tumor cell (CTC) clusters containing three or more cells.

Key Points of the Research

This study highlighted several critical aspects of HER2-positive breast cancer treatment, including:

• Approximately 15–20% of breast cancer cases are HER2-positive, presenting challenges as many patients face resistance to conventional therapies.
• While immunotherapy has shown promise in various solid tumors, its efficacy in HER2-positive breast cancer remains limited, emphasizing the need for alternative therapies.
• Profiling through liquid biopsies confirmed that Paxalisib effectively disrupted CTCs and CTC clusters, identified as indicators of aggressive disease.
• Immunofluorescence testing demonstrated complete disruption of these CTC clusters in treated patient samples.

Expert Insights on the Research

Dr. John Friend, CEO of Kazia Therapeutics, expressed enthusiasm regarding these findings. He noted, "These ex vivo results expand our understanding of Paxalisib’s potential, showing effectiveness in HER2-positive disease. Disrupting CTC clusters, known for being linked to metastasis, offers a transformative opportunity in treatment. The precision medicine aspect, which allows tracking metastatic burden through biomarkers, is particularly exciting. It aligns with our goal of addressing the unmet needs of patients facing limited therapeutic options."

Ongoing Clinical Trials and Future Directions

These significant findings support Kazia’s ongoing Phase 1b trial, which investigates Paxalisib in Stage IV triple-negative breast cancer (TNBC). Early findings from this trial in summer 2025 have indicated substantial reductions in circulating tumor cells and clusters, enhancing the understanding of Paxalisib's potential across varied breast cancer subtypes.

As a next step, detailed datasets, including comprehensive analyses of metastatic signatures and disrupted progenitor populations in HER2-positive patients, are set to be presented at an upcoming global oncology conference in 2025. This progression reflects Kazia's commitment to advancing research in targeted therapies.

About Kazia Therapeutics Limited

Kazia Therapeutics Limited focuses on developing innovative cancer therapies. Their lead candidate, Paxalisib, is designed to penetrate the blood-brain barrier effectively. Since acquiring rights from Genentech in late 2016, Paxalisib has undergone testing in multiple clinical trials. Notably, a recently reported Phase 2/3 study in glioblastoma (GBM-Agile) emphasized its value in managing aggressive cancers. Additionally, ongoing trials target advanced breast cancer, brain metastases, and other critical conditions, with encouraging interim results reported.

Paxalisib received Orphan Drug Designation from the FDA for glioblastoma and is advancing towards pivotal studies that aim to secure regulatory approval. Kazia is also working on EVT801, a small molecule inhibitor expected to offer promising synergy with immuno-oncology therapies.

Contact Information for Further Inquiries

For additional information, investors and media can reach out to Alex Star, Managing Director at LifeSci Advisors LLC, via email at Astarr@lifesciadvisors.com or call +1-201-786-8795.

Frequently Asked Questions

What are the key findings from Kazia Therapeutics' study?

The study highlighted that Paxalisib effectively disrupted circulating tumor cell clusters in patients with HER2-positive breast cancer.

What is Paxalisib?

Paxalisib is an investigational PI3K–mTOR inhibitor being developed by Kazia Therapeutics for various cancer types, including breast cancer.

How does this study impact current cancer treatments?

The findings may lead to new therapeutic avenues for patients with limited options, especially in HER2-positive and triple-negative breast cancer.

What are the next steps for Kazia Therapeutics?

Kazia plans to present detailed datasets at an upcoming global oncology conference and continues to focus on clinical trials for Paxalisib.

Who can I contact for more information about Kazia Therapeutics?

For inquiries, Alex Star, Managing Director at LifeSci Advisors LLC, is available at Astarr@lifesciadvisors.com.

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