Kazia Therapeutics Announces Transformative Preclinical Data Demonstrating Paxalisib's Potential to Overcome Immunotherapy Resistance in Triple-Negative Breast Cancer (TNBC)

Core Insights - Kazia Therapeutics Limited announced transformative preclinical research on paxalisib, highlighting its potential in treating triple-negative breast cancer (TNBC) [1][2] - The research indicates paxalisib can reprogram the tumor microenvironment and enhance immune response, showing synergy with immune checkpoint inhibitors [2][6] - The publication of this research supports the ongoing Phase 1b clinical trial of paxalisib in advanced breast cancer [4] Preclinical Research Findings - Conducted by Professor Sudha Rao at QIMR Berghofer Medical Research Institute, the study shows paxalisib's ability to remodel the TNBC tumor microenvironment, increasing CD4+ and CD8+ T cell infiltration and activation [2][6] - The combination of paxalisib with KEYTRUDA® (pembrolizumab) demonstrated significant antitumor activity, leading to robust tumor regression and prolonged survival in preclinical models [6] Clinical Development - Kazia has initiated a Phase 1b trial evaluating paxalisib in combination with checkpoint inhibitors and chemotherapy for advanced breast cancer, marking a significant step in clinical translation [5] - The company has previously conducted ten clinical trials for paxalisib, primarily focused on brain cancers, and is now expanding its application to solid tumors [5] Regulatory Designations - Paxalisib has received multiple designations from the FDA, including Orphan Drug Designation and Fast Track Designation for glioblastoma and other conditions, indicating its potential therapeutic value [5] Company Overview - Kazia Therapeutics is an oncology-focused drug development company based in Sydney, Australia, with a lead program centered on paxalisib, a PI3K/Akt/mTOR pathway inhibitor [5]