Kazia Therapeutics Targets Breast Cancer Resistance with Paxalisib

The Sydney-based biotechnology firm plans to modify its ongoing triple-negative breast cancer trial to include three new study arms focused on HR+/HER2- metastatic disease. These arms will evaluate varying dosages of paxalisib alongside fulvestrant and palbociclib. According to Kazia, the expansion is supported by data indicating that paxalisib acts through a distinct epigenetic mechanism, setting it apart from other FDA-approved PI3K/mTOR inhibitors.

Dr. John Friend, CEO of Kazia, noted that HR+/HER2- breast cancer accounts for up to 70% of all diagnoses, creating a persistent need for effective treatments after standard therapies fail. The company has identified a high-risk subset of these patients using a novel PI3K/mTOR biomarker, which may allow for more precise patient selection in upcoming trials. Kazia expects to enroll the first patient for this study by the end of 2026, with full enrollment slated for 2027 and a final data readout projected for 2028.