Kazia expands paxalisib breast cancer trial

• Kazia Therapeutics reported preclinical data showing paxalisib activity in HR+/HER2- breast cancer models.
• The company will expand its clinical trial to evaluate paxalisib combinations in metastatic breast cancer.
• Kazia expects patient enrollment to begin before the end of 2026.

Kazia Therapeutics (NASDAQ:KZIA) reported preclinical results showing its PI3K/mTOR inhibitor paxalisib produced antitumor activity when combined with standard therapies in HR+/HER2- breast cancer models.

The company said the findings included resensitization of CDK4/6 inhibitor-resistant tumors and supported expansion of its ongoing TNBC clinical trial into a pre-treated HR+/HER2- metastatic breast cancer cohort.

The expanded study will evaluate paxalisib plus fulvestrant with palbociclib at 15 mg and 30 mg doses compared with fulvestrant alone in a three-arm cohort.

Kazia filed a provisional patent related to the program and expects trial sites to begin activation and enroll the first patient before year-end 2026.

Kazia Therapeutics develops cancer therapies focused on targeted treatments for solid tumors and other oncology indications.

The company expects full enrollment in the expanded program by the end of 2027 and plans a complete data readout in 2028, with recent financing expected to support completion of the program.