Kazia Therapeutics Limited , an oncology-focused drug development company, has announced the regulatory approval and launch of the ABC-Pax (Advanced Breast Cancer – Paxalisib) clinical trial. This first-of-its-kind study evaluates the combination of paxalisib and immunotherapy in patients with triple-negative breast cancer (TNBC)—one of the most aggressive and treatment-resistant forms of the disease.
ABC-Pax is a multi-centre, open-label Phase 1b trial that will assess the safety and efficacy of paxalisib in combination with KEYTRUDA® (pembrolizumab) or LYNPARZA® (olaparib). The study, conducted at leading cancer centers in Queensland, Australia, aims to enroll 24 patients, who will receive the combination therapy for up to 12 months.
This trial builds on groundbreaking research led by QIMR Berghofer scientists, in collaboration with Kazia Therapeutics, demonstrating that paxalisib combined with immunotherapy triggers epigenetic reprogramming of dormant cancer cells. This mechanism enhances immune system recognition and tumor eradication, a strategy showcased in preclinical data presented at the San Antonio Breast Cancer Symposium (December 12, 2024).
Dr. John Friend, CEO of Kazia Therapeutics, emphasized the study’s potential impact:
"The novel combination of paxalisib and immunotherapy represents a significant step forward in the treatment of aggressive breast cancers. We are excited to support this pioneering clinical study and advance therapeutic options for patients."
Professor Sudha Rao of QIMR Berghofer highlighted the urgency of innovation in TNBC treatment:
"There is currently no cure for triple-negative breast cancer, and patient survival remains distressingly low. This study seeks to extend survival and improve quality of life by targeting dormant cancer cells and reactivating the immune system."
The ABC-Pax trial will also incorporate a liquid biopsy digital pathology platform, developed by Professor Rao’s team, enabling real-time monitoring of cancer and immune cell behavior from blood samples—offering a breakthrough in precision medicine.
The trial is now open for enrollment at the Royal Brisbane and Women’s Hospital, with plans to expand to additional sites in Australia.
