Kazia Therapeutics Announces First Patient Dosed in Phase 1b Trial of Paxalisib in Advanced Breast Cancer

Core Insights - Kazia Therapeutics has initiated a Phase 1b clinical trial for paxalisib, targeting advanced breast cancer, marking a significant step in expanding its application beyond brain cancer [1][3] - The trial will evaluate paxalisib in combination with established therapies like olaparib and pembrolizumab, focusing on safety, tolerability, and preliminary efficacy [2][6] Study Design - The trial is a multi-center, open-label, randomized study with two treatment arms: Arm A will assess paxalisib with olaparib, while Arm B will combine paxalisib with pembrolizumab and standard chemotherapy [2][6] - Participants will undergo deep biomarker profiling to support future development and assess early clinical activity signals [2] Strategic Significance - The integration of paxalisib into combination regimens is part of Kazia's strategy to enhance value through differentiated science and collaborations [5] - The trial aims to provide insights into how paxalisib may enhance the effectiveness of immune checkpoint inhibitors and DNA repair-targeted therapies [6] Company Background - Kazia Therapeutics is an oncology-focused biotechnology company based in Sydney, Australia, with a lead program centered on paxalisib, a dual PI3K/mTOR inhibitor [5][7] - The company has previously conducted multiple clinical trials for paxalisib, including studies in glioblastoma and other brain cancers, with several trials showing promising interim data [7]