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Kazia Therapeutics Announces the Filing of Provisional Patent for Novel Strategy, Supported by Preclinical Data, to Prevent Metastatic Recurrence in Triple-Negative Breast Cancer

  • Kazia Therapeutics filed a provisional patent application for a novel strategy to prevent metastatic recurrence in high-risk early-stage triple-negative breast cancer (TNBC).
  • Preclinical findings from a high-risk early-stage TNBC model showed that adding paxalisib to standard neoadjuvant chemotherapy, anti-PD-1 immunotherapy, and surgery reduced residual disease and local recurrence by 95% while lowering lung metastatic burden by 40%.
  • Ex vivo studies on patient tumor samples revealed that paxalisib completely disrupted 100% of circulating tumor cell clusters.
  • The strategy targets biological programs allowing surviving cells to evade immune surveillance, rather than solely focusing on killing tumor cells.
  • Current clinical development includes an ongoing Phase Ib study of paxalisib with pembrolizumab and chemotherapy in advanced metastatic TNBC, which showed preliminary objective tumor responses and CTC cluster disruption.
  • Kazia is actively evaluating opportunities to broaden paxalisib's clinical development into earlier-stage TNBC based on the convergence of preclinical and translational data.
  • Paxalisib is an investigational brain-penetrant PI3K/Akt/mTOR pathway inhibitor licensed from Genentech, with prior Orphan Drug and Fast Track Designations granted by the FDA for glioblastoma and other indications.