Kazia Therapeutics announces the launch of a groundbreaking trial with paxalisib in combination with immunotherapy in women with advanced breast cancer
Kazia Therapeutics (NASDAQ: KZIA) has announced the launch of ABC-Pax, a groundbreaking clinical trial combining paxalisib with immunotherapy for advanced breast cancer treatment. The phase 1b study will evaluate paxalisib in combination with KEYTRUDA® or LYNPARZA® in women with triple negative breast cancer.
The multi-centre, open-label trial will enroll 24 patients from Queensland, Australia cancer centres, with treatment duration up to 12 months. The study follows promising preclinical research presented at the San Antonio Breast Cancer Symposium in December 2024, showing that the combination triggers epigenetic re-programming of dormant cancer cells, making them visible to the immune system.
The trial will utilize a non-invasive liquid biopsy digital pathology platform to monitor treatment effectiveness in real-time through blood sample analysis. The study is currently open for enrollment at the Royal Brisbane and Women's Hospital, with plans for expansion to other Australian sites.
Kazia Therapeutics (NASDAQ: KZIA) ha annunciato il lancio di ABC-Pax, uno studio clinico innovativo che combina paxalisib con immunoterapia per il trattamento del cancro al seno avanzato. Lo studio di fase 1b valuterà paxalisib in combinazione con KEYTRUDA® o LYNPARZA® in donne affette da cancro al seno triplo negativo.
Lo studio multicentrico, in aperto, recluterà 24 pazienti dai centri oncologici del Queensland, Australia, con una durata del trattamento di fino a 12 mesi. Lo studio segue promesse di ricerche precliniche presentate al Simposio sul Cancro al Seno di San Antonio nel dicembre 2024, che mostrano come la combinazione attivi il riprogrammazione epigenetica delle cellule tumorali dormienti, rendendole visibili al sistema immunitario.
La sperimentazione utilizzerà una piattaforma di patologia digitale per biopsia liquida non invasiva per monitorare l'efficacia del trattamento in tempo reale attraverso l'analisi dei campioni di sangue. Lo studio è attualmente aperto per il reclutamento presso il Royal Brisbane and Women's Hospital, con piani di espansione ad altri centri in Australia.
Kazia Therapeutics (NASDAQ: KZIA) ha anunciado el lanzamiento de ABC-Pax, un ensayo clínico innovador que combina paxalisib con inmunoterapia para el tratamiento del cáncer de mama avanzado. El estudio de fase 1b evaluará paxalisib en combinación con KEYTRUDA® o LYNPARZA® en mujeres con cáncer de mama triple negativo.
El ensayo multicéntrico, abierto, reclutará a 24 pacientes de los centros oncológicos de Queensland, Australia, con una duración del tratamiento de hasta 12 meses. El estudio sigue investigaciones preclínicas prometedoras presentadas en el Simposio sobre Cáncer de Mama de San Antonio en diciembre de 2024, que muestran que la combinación desencadena la reprogramación epigenética de las células cancerosas latentes, haciéndolas visibles para el sistema inmunológico.
El ensayo utilizará una plataforma de patología digital para biopsia líquida no invasiva para monitorear la efectividad del tratamiento en tiempo real a través del análisis de muestras de sangre. El estudio está actualmente abierto para inscripción en el Royal Brisbane and Women's Hospital, con planes de expansión a otros centros en Australia.
Kazia Therapeutics (NASDAQ: KZIA)는 고급 유방암 치료를 위해 paxalisib과 면역 요법을 결합한 획기적인 임상 시험 ABC-Pax의 출범을 발표했습니다. 1b 단계 연구는 삼중 음성 유방암에 걸린 여성에서 paxalisib을 KEYTRUDA® 또는 LYNPARZA®와 함께 평가합니다.
이 다기관 공개 시험은 호주 퀸즐랜드의 암 센터에서 24명의 환자를 모집하며, 치료 기간은 최대 12개월입니다. 이 연구는 2024년 12월 샌안토니오 유방암 심포지엄에서 발표된 희망적인 전임상 연구를 따르며, 이 연구는 조용한 암세포의 에피제네틱 재프로그래밍을 유발하여 면역계에 드러나게 한다는 것을 보여줍니다.
시험은 혈액 샘플 분석을 통해 실시간으로 치료 효과를 모니터링하기 위해 비침습적 액체 생검 디지털 병리 플랫폼을 사용할 것입니다. 이 연구는 현재 로열 브리즈번 및 여성 병원에서 모집 중이며, 호주의 다른 장소로 확장할 계획입니다.
Kazia Therapeutics (NASDAQ: KZIA) a annoncé le lancement d'ABC-Pax, un essai clinique révolutionnaire combinant le paxalisib à une immunothérapie pour le traitement du cancer du sein avancé. L'étude de phase 1b évaluera le paxalisib en combinaison avec KEYTRUDA® ou LYNPARZA® chez des femmes atteintes de cancer du sein triple négatif.
L'essai multicentrique et en ouvert recrutera 24 patientes de centres de cancer dans le Queensland, en Australie, avec une durée de traitement allant jusqu'à 12 mois. L'étude fait suite à des recherches précliniques prometteuses présentées au Symposium sur le Cancer du Sein de San Antonio en décembre 2024, montrant que la combinaison déclenche une reprogrammation épigénétique des cellules cancéreuses dormantes, les rendant visibles pour le système immunitaire.
L'essai utilisera une plateforme de pathologie numérique pour biopsie liquide non invasive afin de surveiller l'efficacité du traitement en temps réel grâce à l'analyse des échantillons de sang. L'étude est actuellement ouverte à l'inscription au Royal Brisbane and Women's Hospital, avec des projets d'expansion vers d'autres sites en Australie.
Kazia Therapeutics (NASDAQ: KZIA) hat die Einführung von ABC-Pax angekündigt, einer bahnbrechenden klinischen Studie, die Paxalisib mit Immuntherapie zur Behandlung von fortgeschrittenem Brustkrebs kombiniert. Die Phase-1b-Studie wird Paxalisib in Kombination mit KEYTRUDA® oder LYNPARZA® bei Frauen mit dreifach negativem Brustkrebs untersuchen.
Die multizentrische, offene Studie wird 24 Patienten aus den Krebszentren Queensland, Australien, einschließen, mit einer Behandlungsdauer von bis zu 12 Monaten. Die Studie folgt vielversprechenden präklinischen Forschungsergebnissen, die im Dezember 2024 auf dem San Antonio Breast Cancer Symposium präsentiert wurden, und zeigt, dass die Kombination eine epigenetische Reprogrammierung schlafender Krebszellen auslöst, wodurch sie für das Immunsystem sichtbar werden.
Die Studie wird eine nicht-invasive digitale Pathologie-Plattform für Flüssigbiopsien nutzen, um die Effektivität der Behandlung in Echtzeit durch Blutprobenanalyse zu überwachen. Die Studie ist derzeit im Royal Brisbane and Women's Hospital für die Einschreibung geöffnet, mit Plänen zur Erweiterung auf andere australische Standorte.
- Launch of innovative phase 1b trial combining paxalisib with established cancer drugs KEYTRUDA® and LYNPARZA®
- Promising preclinical data showing novel mechanism of action against treatment-resistant cancer
- Implementation of advanced real-time monitoring through liquid biopsy platform
- Early-stage trial with patient enrollment (24 patients)
- Study restricted to Australian sites initially
- No efficacy data available yet for the combination therapy
Insights
The launch of the ABC-Pax trial represents a potentially significant advancement in oncology therapeutics, particularly for the challenging triple-negative breast cancer (TNBC) market. The trial's design demonstrates several innovative elements that warrant attention:
The combination approach with KEYTRUDA® (Merck's blockbuster) and LYNPARZA® (AstraZeneca/Merck's established PARP inhibitor) is strategically significant. These partnerships with major pharmaceutical products could accelerate market acceptance if successful. The dual-mechanism approach - making cancer cells visible while boosting immune response - addresses two critical challenges in immunotherapy resistance.
The integrated liquid biopsy platform is a important differentiator. Real-time monitoring of treatment effectiveness through blood samples could significantly reduce treatment costs and improve patient outcomes. This technology could become a valuable companion diagnostic tool, potentially creating an additional revenue stream.
However, investors should note key considerations:
- The small trial size of 24 patients suggests this is primarily a proof-of-concept study
- The 12-month treatment duration means meaningful data will take time to materialize
- Competition in the TNBC space is intense, with multiple combination approaches being tested
The preclinical data presented at San Antonio Breast Cancer Symposium provides scientific validation, but the true value proposition lies in the potential for this approach to extend beyond TNBC to other aggressive cancers. The epigenetic reprogramming mechanism could have broader applications in various immunotherapy-resistant cancers, significantly expanding the market opportunity.
The ABC-Pax (Advanced Breast Cancer – Paxalisib) study is the first known trial conducted to assess the safety and efficacy of paxalisib in combination with KEYTRUDA® (pembrolizumab) or LYNPARZA® (olaparib) in women with triple negative breast cancer. ABC-Pax is a multi-centre, open-label phase 1b study that will enroll 24 patients from top cancer centres in
The ABC-Pax study stems from pivotal research led by QIMR Berghofer scientists in collaboration with Kazia Therapeutics, which combined its drug candidate, paxalisib, with immunotherapy in pre-clinical models. The team discovered that this combination approach triggers a novel molecular program by epigenetic re-programming of dormant cancer cells, making them visible to the immune system, while also reinvigorating the immune cells to fight the tumour cells. These new preclinical data were presented at San Antonio Breast Cancer Symposium on December 12, 2024, and highlight the potential therapeutic synergies between paxalisib and checkpoint inhibitor pembrolizumab (KEYTRUDA®), as well as between paxalisib and poly (ADP-ribose) polymerase inhibitor olaparib (LYNPARZA®), when used in combination in a preclinical model of immunotherapy-resistant triple negative breast cancer. The clinical trial is open for enrollment at the Royal Brisbane and Women's Hospital and plans to expand to other sites in
Kazia Therapeutics CEO, Dr John Friend, said the novel combination treatment may have the potential to transform the treatment of triple-negative breast cancer and other aggressive tumour types.
"The novelty of the science that Professor Rao has proposed with this dual combination of paxalisib and immunotherapy could advance the treatment of women with aggressive breast cancer, and we are excited to support this unique clinical study," Dr John Friend, CEO Kazia Therapeutics said.
QIMR Berghofer's Professor Sudha Rao said, "There is no cure for triple negative breast cancer and the life expectancy for these women is tragically short. We want to identify treatments to extend the duration and quality of life of these patients. The hope is to prolong patient survival through the new combined therapy, which targets the dormant cancer cells that drive the spread and recurrence of the disease and rejuvenates the immune system to more effectively fight the cancer."
The ABC-Pax trial will also evaluate a non-invasive liquid biopsy digital pathology platform developed by Professor Rao and her team, which can monitor the behaviour of cancer cells and immune cells in real time from a blood sample.
"By regularly analysing blood samples from trial participants using our liquid biopsy digital pathology platform, we can track the effectiveness of the treatment in real time. We believe this approach represents a major advance in precision medicine by offering a faster and more accurate way to monitor patient progress," Professor Rao said.
About Kazia Therapeutics Limited
Kazia Therapeutics Limited (NASDAQ: KZIA) is an oncology-focused drug development company, based in Sydney,
Forward-Looking Statements
This announcement may contain forward-looking statements, which can generally be identified as such by the use of words such as "may," "will," "estimate," "future," "forward," "anticipate," or other similar words. Any statement describing Kazia's future plans, strategies, intentions, expectations, objectives, goals or prospects, and other statements that are not historical facts, are also forward-looking statements, including, but not limited to, statements regarding: the timing for results and data related to Kazia's clinical and preclinical trials, Kazia's strategy and plans with respect to its programs, including paxalisib and EVT801, the ABC-Pax study and the potential results of combination studies of paxalisib, the potential benefits of paxalisib as an investigational PI3K/mTOR inhibitor, timing for any regulatory submissions or discussions with regulatory agencies, and the potential market opportunity for paxalisib. Such statements are based on Kazia's current expectations and projections about future events and future trends affecting its business and are subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements, including risks and uncertainties: associated with clinical and preclinical trials and product development, related to regulatory approvals, and related to the impact of global economic conditions. These and other risks and uncertainties are described more fully in Kazia's Annual Report, filed on form 20-F with the SEC, and in subsequent filings with the United States Securities and Exchange Commission. Kazia undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required under applicable law. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this announcement.
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