Accessibility StatementSkip Navigation SYDNEY, Nov. 18, 2025 /PRNewswire/ -- Kazia Therapeutics Limited (Nasdaq: KZIA), an oncology-focused drug development company, today announced that a patient with stage IV triple-negative breast cancer (TNBC) treated under an FDA-authorized single-patient expanded access protocol combining paxalisib with pembrolizumab (Keytruda®) and standard chemotherapy has achieved an initial immune-complete response (iCR) per iRECIST criteria. This outcome suggests a profound radio ...

Accessibility StatementSkip Navigation SYDNEY, Oct. 27, 2025 /PRNewswire/ -- Kazia Therapeutics Limited ("Kazia" or the "Company") today announced its intention to request and hold a follow-up Type C meeting with the U.S. Food & Drug Administration (FDA) to discuss overall survival (OS) findings in newly diagnosed glioblastoma (GBM) patients treated with paxalisib and to seek agency feedback on a potential regulatory pathway aligned with the FDA Oncology Center of Excellence's Project FrontRunner initiative ...

Core Insights - Kazia Therapeutics Limited reported an 86% reduction in tumor burden in a single patient with triple-negative breast cancer (TNBC) after three weeks of treatment with a combination of immunotherapy, chemotherapy, and the investigational drug paxalisib [1][2][3] Company Overview - Kazia Therapeutics is an oncology-focused drug development company based in Sydney, Australia, primarily developing paxalisib, a pan-PI3K/mTOR inhibitor [5] - The company has conducted multiple clinical trials involving paxalisib, including a completed Phase 2/3 study in glioblastoma and ongoing trials in advanced breast cancer and other cancers [5] Clinical Trial Information - Kazia is conducting a multi-centered Phase 1b study in Australia to evaluate the safety and preliminary anti-tumor activity of paxalisib in combination with Keytruda® and chemotherapy for advanced breast cancer, including TNBC [4] - The ongoing trial aims to assess the effects on circulating tumor cells and cluster dynamics to understand how paxalisib may enhance immunotherapy responsiveness [4] Patient Case Details - The patient treated under the expanded-access protocol was a 40+ year old female diagnosed with TNBC in April 2023, who had no residual cancer after initial treatments but later developed metastatic disease [2] - The treatment regimen included immunotherapy, chemotherapy, and paxalisib, leading to significant tumor regression [2][3]

Accessibility StatementSkip Navigation SYDNEY, Oct. 1, 2025 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), a clinical-stage biotechnology company developing innovative therapies for brain cancers, today announced its participation in a fully funded Australian Medical Research Future Fund (MRFF) project titled "Sequential & Temporal Therapeutic Agility for the Treatment of Diffuse Midline Glioma (DMG)". Under this three-year initiative, a consortium of leading researchers will establish DMG-ADAP ...

Core Insights - Kazia Therapeutics Limited announced new findings from a collaborative research program indicating that paxalisib, an investigational PI3K–mTOR inhibitor, significantly reduces circulating tumor cells (CTCs) in Stage IV HER2-positive metastatic breast cancer patients [2][3] Company Overview - Kazia Therapeutics is an oncology-focused drug development company based in Sydney, Australia, with a lead program centered on paxalisib, which targets multiple forms of cancer [5] - The company has been developing paxalisib since it was licensed from Genentech in late 2016, and it has been involved in ten clinical trials for various cancers [5] Research Findings - In an ex vivo study, paxalisib monotherapy achieved a complete (100%) disruption of CTC clusters containing three or more cells, which are associated with metastasis and poor prognosis [2][6] - The results extend the understanding of paxalisib's potential beyond triple-negative breast cancer into HER2-positive disease, highlighting its ability to disrupt CTC clusters [3][6] - The findings complement ongoing Phase 1b trials in Stage IV triple-negative breast cancer, where significant reductions in CTCs and clusters have been observed [3] Future Directions - Detailed datasets regarding metastatic signatures and disrupted progenitor populations in Stage IV HER2-positive breast cancer have been submitted for presentation at an upcoming global oncology meeting in 2025 [4]

Group 1 - Kazia Therapeutics Limited has entered into a securities purchase agreement for a private placement of equity securities, raising approximately $2.0 million [1][2] - The securities in the PIPE are priced at a 5% premium to the closing price of Kazia's ADSs on July 31, 2025, and the transaction is expected to close on August 4, 2025 [1][2] - The net proceeds from the PIPE will be used to support the clinical development of lead programs, including paxalisib and EVT801, as well as for general corporate purposes [2][3] Group 2 - The CEO of Kazia Therapeutics expressed gratitude for investor support and highlighted the importance of the additional capital for advancing clinical-stage assets [3] - The securities sold in this PIPE are not registered under the Securities Act of 1933 and will require a shelf registration statement to be filed with the SEC within 60 days of closing [3][4] - Kazia Therapeutics is focused on developing innovative oncology treatments, with lead programs targeting brain cancer and advanced solid tumors [6]

Core Insights - Kazia Therapeutics has announced preliminary results from its Phase 1b trial involving Paxalisib, pembrolizumab, and standard chemotherapy, showing promising outcomes in a patient with metastatic triple-negative breast cancer [1][5][6] Patient Profile - The trial's first patient is a 61-year-old female diagnosed with metastatic triple-negative breast cancer, specifically localized to the left upper lobe of the lung [3] Clinical Significance of Patient Data - Circulating tumor cell (CTC) clusters are critical in metastasis and are associated with poor prognosis; they can resist apoptosis and evade immune detection [4] - The combination treatment of Paxalisib and immunotherapy resulted in a rapid reduction of both CTC numbers and clusters, which is not typically observed with chemotherapy or immunotherapy alone [5][6] Mechanistic Insights - The early data aligns with preclinical findings that suggest Paxalisib disrupts both single CTCs and multicellular clusters, indicating a mechanistic synergy [2][5] Next Steps - The company plans to explore the relationship between CTC kinetics and radiographic responses, continue patient enrollment, and conduct a comprehensive analysis of the immune microenvironment and CTC kinetics [7] - The investigational regimen includes Paxalisib, pembrolizumab, and chemotherapy, with results showing over 50% reduction in total CTC count and a notable decrease in CTC clusters [7] Company Overview - Kazia Therapeutics is an oncology-focused drug development company based in Sydney, Australia, with its lead program being Paxalisib, which targets the PI3K/Akt/mTOR pathway for various cancers [9]

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]

Core Insights - Kazia Therapeutics Limited has made significant advancements in its clinical programs and corporate strategy, particularly with its lead drug paxalisib, which is being evaluated for multiple cancer types [2][3] Pipeline - Paxalisib - The company received a research grant from The Michael J. Fox Foundation to explore paxalisib's potential as a treatment for Parkinson's disease, funding preclinical studies at The Hebrew University of Jerusalem [4] - A clinical trial has been launched to evaluate the combination of paxalisib with immunotherapy in patients with advanced breast cancer, specifically targeting triple-negative breast cancer [4] - Kazia has aligned with the FDA on the design of a pivotal phase 3 study for paxalisib in glioblastoma, which will enroll approximately 366 patients and compare paxalisib to standard of care [8] Pipeline - EVT801 - The last patient follow-up in a Phase 1 study of EVT801 for advanced solid tumors was completed, with final data expected in Q2 2025 [6] Corporate Developments - Kazia raised $3 million in capital during Q1 2025, including $1 million in non-dilutive funding [2][3] - The company received a notification from Nasdaq regarding its Market Value of Listed Securities falling below $35 million, with a compliance period until November 10, 2025 [9] - Kazia executed a reverse ADS split to maintain compliance with Nasdaq's minimum bid price requirement [9] - The company sold all intellectual property rights to Cantrixil for $1 million, as Vivesto decided not to pursue its development in ovarian cancer [9] - CEO Dr. John Friend purchased 8,000 ADSs at a split-adjusted price of $4.2465 per ADS [9]

Core Viewpoint - Kazia Therapeutics Limited has sold all intellectual property and trademark rights to its oncology drug candidate Cantrixil to Vivesto for USD $1 million, providing non-dilutive funding to advance its clinical-stage pipeline [1][3]. Group 1: Transaction Details - Kazia will receive USD $1 million from Vivesto for the rights to Cantrixil [1]. - Vivesto had previously licensed exclusive global development and commercialization rights for Cantrixil from Kazia in March 2021 [2]. - Vivesto has decided not to pursue Cantrixil for ovarian cancer and is now exploring it for hematological cancers [2]. Group 2: Company Overview - Kazia Therapeutics is an oncology-focused drug development company based in Sydney, Australia, with a lead program, paxalisib, targeting multiple forms of brain cancer [4]. - Paxalisib has undergone ten clinical trials and has received various designations from the FDA, including Orphan Drug Designation and Fast Track Designation for glioblastoma [4]. - The company is also developing EVT801, a small molecule inhibitor of VEGFR3, which has shown activity against a broad range of tumor types [4].