Kazia Therapeutics(US:KZIA) Prnewswire·2025-01-30 12:30Core Viewpoint - Kazia Therapeutics Limited has received regulatory approval to launch a clinical trial for the combination of paxalisib and immunotherapy in patients with advanced breast cancer, specifically targeting triple-negative breast cancer, which is known for its aggressive nature and treatment resistance [1][2][4]. Group 1: Clinical Trial Details - The ABC-Pax study is a multi-centre, open-label phase 1b trial that will enroll 24 patients from leading cancer centers in Queensland, Australia, with treatment lasting up to 12 months [2]. - The trial aims to assess the safety and efficacy of paxalisib in combination with either KEYTRUDA® (pembrolizumab) or LYNPARZA® (olaparib) [2][3]. - Enrollment for the clinical trial is currently open at the Royal Brisbane and Women's Hospital, with plans to expand to additional sites in Australia [3]. Group 2: Scientific Background - Research led by QIMR Berghofer scientists in collaboration with Kazia Therapeutics has shown that the combination of paxalisib and immunotherapy can trigger a novel molecular program that makes dormant cancer cells visible to the immune system [3]. - The preclinical data presented at the San Antonio Breast Cancer Symposium on December 12, 2024, highlighted potential therapeutic synergies between paxalisib and the checkpoint inhibitor pembrolizumab, as well as with the poly (ADP-ribose) polymerase inhibitor olaparib [3]. Group 3: Company Insights - Kazia Therapeutics is focused on developing paxalisib, an investigational drug targeting the PI3K/Akt/mTOR pathway, which has been involved in ten clinical trials for various brain cancers [7]. - The company has received multiple designations from the FDA for paxalisib, including Orphan Drug Designation and Fast Track Designation for glioblastoma and other conditions [7]. - Kazia is also developing EVT801, a small-molecule inhibitor of VEGFR3, which has shown promise in preclinical studies and has completed a Phase I study [8].