US Market News
1月前
Kazia Therapeutics Appoints James Levine as Chief Financial OfficerJune 2, 2026 7:30 AM
PR Newswire (US) SYDNEY, June 2, 2026 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA) ("Kazia," "Kazia Therapeutics" or the "Company"), a clinical-stage oncology company advancing therapies designed to reprogram cancer biology and overcome treatment resistance, today announced the appointment of James Levine as Chief Financial Officer, effective June 1, 2026. Mr. Levine brings more than two decades of experience across investment banking, executive and financial leadership at publicly traded biotech companies."James has built an impressive career leading financial strategy, strategic transactions and major pharmaceutical collaborations, following an extensive career in investment banking," said Dr. John Friend, CEO, Kazia Therapeutics. "As we advance paxalisib and progress our pipeline, James' expertise will be central to helping us capitalize on that momentum and continue building long-term value for patients and shareholders."Most recently, Mr. Levine served as Chief Financial Officer of Cardiff Oncology, a clinical-stage oncology company developing a PLK1 inhibitor therapy for solid tumors. Prior to Cardiff Oncology, Mr. Levine served as CFO of Cidara Therapeutics, an antifungal and antiviral biotech company, where he led the financial structuring of a $568 million licensing collaboration with Mundipharma and a $780 million global partnership with Janssen Pharmaceuticals (Johnson & Johnson). He also served as CEO of Verenium Corporation, an industrial biotech company, where he executed major asset sales for total proceeds of approximately $200 million, as well as Sapphire Energy, a human nutrition-focused biotech.Earlier in his career, Mr. Levine spent 12 years at Goldman Sachs & Co. as a Managing Director advising pharmaceutical and biotech clients across the U.S. and Europe on financings, mergers and acquisitions and strategic transactions, including landmark deals such as the Glaxo Wellcome and SmithKline Beecham merger. Mr. Levine holds a Master of Business Administration degree from The Wharton School at the University of Pennsylvania."I am very excited to be joining Kazia as the Company advances paxalisib across multiple indications and builds out a promising pipeline targeting novel mechanisms of treatment resistance," added Mr. Levine. "I look forward to working closely with the management team to help translate Kazia's scientific progress into strategic and financial outcomes as we approach what we expect to be a period of meaningfulclinical and strategic milestones for the Company."About Kazia TherapeuticsKazia Therapeutics Limited (NASDAQ: KZIA) is an oncology-focused drug development company, based in Sydney, Australia. The Company's lead asset, paxalisib, is an investigational brain penetrant inhibitor of the PI3K/Akt /mTOR pathway, which is being developed to treat multiple forms of cancer. Licensed from Genentech in late 2016, paxalisib is or has been the subject of 10 clinical trials. A completed Phase 2/3 study in glioblastoma (GBM-Agile) was reported in 2024, and discussions are ongoing for designing and executing a pivotal registrational study in pursuit of a standard approval. Other clinical trials involving paxalisib are ongoing in advanced breast cancer, brain metastases, diffuse midline gliomas, and primary central nervous system lymphoma, with several of these trials having reported encouraging interim data. Paxalisib was granted Orphan Drug Designation for glioblastoma by the U.S. Food and Drug Administration (FDA) in February 2018, and Fast Track Designation (FTD) for glioblastoma in August 2020. Paxalisib was also granted FTD in July 2023 for the treatment of solid tumor brain metastases harboring PI3K pathway mutations in combination with radiation therapy. Additionally, paxalisib was granted Rare Pediatric Disease Designation and Orphan Drug Designation by the FDA for diffuse intrinsic pontine glioma in August 2020 and for atypical teratoid / rhabdoid tumors in June 2022 and July 2022, respectively. Kazia is also developing EVT801, a small molecule inhibitor of VEGFR3, which was licensed from Evotec SE in April 2021. In addition to its clinical-stage programs, Kazia is advancing NDL2, a potentially first-in-class intracellular PD-L1 protein degrader program targeting a newly identified mechanism of immunotherapy resistance and metastatic progression, as well as MSETC, a potentially first-in-class SETDB1 inhibitor program intended to restore immune signaling in tumors that have become resistant to immunotherapy, including checkpoint inhibitors. Both programs are currently in preclinical development. For more information, please visit www.kaziatherapeutics.com or follow us on X @KaziaTx.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," "expect," "plan," "believe," "potential," 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 Company's expectations regarding its pipeline strategy and future clinical and strategic milestones; the anticipated contributions of Mr. Levine to the Company's business; and Kazia's plans to advance paxalisib and its broader oncology pipeline. 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: the development of early stage therapeutic programs; the conduct of clinical trials, including the ability to enroll patients and achieve anticipated enrollment targets; the preliminary nature of data from a small, open-label clinical study, which may not be predictive of later-stage clinical results; risks related to regulatory approvals; risks related to Kazia's reliance on third-party collaborators and clinical trial sites; risks related to the Company's ability to obtain, maintain and protect its intellectual property; risks related to the impact of global economic conditions; and risks related to Kazia's ability to maintain compliance with the applicable NASDAQ continued listing requirements and standards. These and other risks and uncertainties are described more fully in Kazia's Annual Report on Form 20-F filed 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.Media Contacts Michaela Fawcett / Molly Crawford
KCSA Strategic Communications
mfawcett@kcsa.com / mcrawford@kcsa.com ### View original content:https://www.prnewswire.com/news-releases/kazia-therapeutics-appoints-james-levine-as-chief-financial-officer-302787604.htmlSOURCE Kazia Therapeutics Limited Original: Kazia Therapeutics Appoints James Levine as Chief Financial Officer
US Market News
1月前
Kazia Therapeutics Expands Ongoing Phase 1b Trial of Paxalisib in Advanced Breast CancerMay 26, 2026 7:30 AM
PR Newswire (US) Planned Enrollment to Increase from 12 to 36 Patients Following Continued Encouraging Safety and Tolerability DataSYDNEY, May 26, 2026 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA) ("Kazia" or the "Company"), a clinical-stage oncology company advancing therapies designed to reprogram cancer biology and overcome treatment resistance, today announced plans to expand its ongoing Phase 1b clinical trial evaluating lead asset paxalisib in combination with standard-of-care therapies in patients with advanced triple negative breast cancer ("TNBC"). Based on continued encouraging safety, tolerability and clinical activity data observed to date, planned enrollment has increased from 12 to 36 patients.The expansion is intended to further evaluate the safety, tolerability, dose optimization and preliminary efficacy of the paxalisib-based combination regimen with pembrolizumab and chemotherapy. The expanded dataset is expected to provide a more meaningful assessment of objective response rate ("ORR"), progression-free survival ("PFS") and translational biomarkers. Additional clinical trial updates are anticipated throughout 2026 and into 2027."We remain encouraged by the safety and tolerability data observed to date, and expanding enrollment allows us to generate a broader clinical and translational dataset as we advance paxalisib in difficult-to-treat advanced breast cancer, such as TNBC," said Dr. John Friend, CEO, Kazia Therapeutics. "Paxalisib's mechanism, modulating key resistance and immune-related pathways, addresses the very reasons that current therapies fail, and we believe it holds meaningful potential for an underserved patient population. While we planned to present scientific progress at ASCO 2026, we made the decision to withdraw our abstracts solely to protect our intellectual property position ahead of anticipated filings. The withdrawal was not related to any safety or clinical concerns. We expect to share additional clinical and translational updates in the coming months."The Phase 1b study is evaluating paxalisib in combination with established breast cancer regimens across multiple dose cohorts. The trial expansion is supported by a recently published preclinical study in Molecular Cancer Therapeutics, a journal of the American Association for Cancer Research ("AACR"), demonstrating that dual PI3K/mTOR inhibition with paxalisib altered tumor cell state and immune signaling in preclinical TNBC models. TNBC accounts for approximately 15 to 20 percent of all breast cancer diagnoses and is associated with poorer outcomes relative to other breast cancer subtypes.About Kazia TherapeuticsKazia Therapeutics (NASDAQ: KZIA) is an oncology-focused drug development company, based in Sydney, Australia. The Company's lead asset, paxalisib, is an investigational brain penetrant inhibitor of the PI3K/Akt /mTOR pathway, which is being developed to treat multiple forms of cancer. Licensed from Genentech in late 2016, paxalisib is or has been the subject of 10 clinical trials. A completed Phase 2/3 study in glioblastoma (GBM-Agile) was reported in 2024, and discussions are ongoing for designing and executing a pivotal registrational study in pursuit of a standard approval.Other clinical trials involving paxalisib are ongoing in advanced breast cancer, brain metastases, diffuse midline gliomas, and primary central nervous system lymphoma, with several of these trials having reported encouraging interim data. Paxalisib was granted Orphan Drug Designation for glioblastoma by the U.S. Food and Drug Administration (FDA) in February 2018, and Fast Track Designation (FTD) for glioblastoma in August 2020. Paxalisib was also granted FTD in July 2023 for the treatment of solid tumor brain metastases harboring PI3K pathway mutations in combination with radiation therapy.Additionally, paxalisib was granted Rare Pediatric Disease Designation and Orphan Drug Designation by the FDA for diffuse intrinsic pontine glioma in August 2020 and for atypical teratoid / rhabdoid tumors in June 2022 and July 2022, respectively. Kazia is also developing EVT801, a small molecule inhibitor of VEGFR3, which was licensed from Evotec SE in April 2021. In addition to its clinical-stage programs, Kazia is advancing NDL2, a potentially first-in-class intracellular PD-L1 protein degrader program targeting a newly identified mechanism of immunotherapy resistance and metastatic progression, as well as MSETC, a potentially first-in-class SETDB1 inhibitor program intended to restore immune signaling in tumors that have become resistant to immunotherapy, including checkpoint inhibitors. Both programs are currently in preclinical development. For more information, please visit www.kaziatherapeutics.com or follow us on X @KaziaTx.Forward Looking StatementsThis 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," "expect," "plan," "believe," "potential," 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 planned expansion of the Phase 1b clinical trial of paxalisib in advanced TNBC; the anticipated increase in enrollment from 12 to 36 patients; expectations regarding the safety, tolerability, dose optimization and preliminary efficacy of paxalisib in combination with pembrolizumab and chemotherapy; the potential of paxalisib to treat advanced breast cancer, including TNBC; expectations regarding objective response rate, progression-free survival and translational biomarkers; anticipated timing of clinical trial updates throughout 2026 and into 2027; the timing and content of future public disclosures regarding the Company's clinical programs; the Company's decisions regarding the timing and manner of scientific presentations and publications, including the withdrawal of abstracts from scientific conferences for intellectual property-related reasons; and statements regarding the potential therapeutic benefit of paxalisib to modulate key resistance and immune-related pathways in difficult-to-treat breast cancer populations. 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: the development of early-stage therapeutic programs; the conduct of clinical trials, including the ability to enroll patients and achieve anticipated enrollment targets; the preliminary nature of data from a small, open-label clinical study, which may not be predictive of later-stage clinical results; risks related to regulatory approvals; risks related to Kazia's reliance on third-party collaborators and clinical trial sites; risks related to the Company's ability to obtain, maintain and protect its intellectual property, including decisions regarding the timing and manner of scientific disclosures; risks related to the impact of global economic conditions; and risks related to Kazia's ability to maintain compliance with the applicable NASDAQ continued listing requirements and standards. These and other risks and uncertainties are described more fully in Kazia's Annual Report on Form 20-F filed 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.Media Contact
Michaela Fawcett
KCSA Strategic Communications
mfawcett@kcsa.com View original content:https://www.prnewswire.com/news-releases/kazia-therapeutics-expands-ongoing-phase-1b-trial-of-paxalisib-in-advanced-breast-cancer-302781345.htmlSOURCE Kazia Therapeutics Limited Original: Kazia Therapeutics Expands Ongoing Phase 1b Trial of Paxalisib in Advanced Breast Cancer
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8月前
Kazia Therapeutics Achieves Initial iCR (Immune-Complete Response) in Metastatic TNBC and Delivers Q4 Business Update with Breakthroughs Across Breast Cancer, Immuno-Oncology, and GBM Regulatory Strategy
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 radiologic response in a highly aggressive metastatic cancer subtype.
This development builds upon Kazia's October 2, 2025 announcement reporting an 86% reduction in tumor burden after only three weeks of treatment in the same patient. A PET/CT scan performed after approximately three months of therapy demonstrated complete metabolic resolution of all previously identified lesions, consistent with an initial iCR. The patient remains on therapy and under active clinical monitoring. A follow-up scan will be conducted in accordance with immune-based response assessment guidelines to confirm the initial scan.
Complete responses in stage IV metastatic TNBC are exceedingly uncommon across many therapeutic classes, including immunotherapy, chemotherapy, and antibody–drug conjugates. For example, pembrolizumab monotherapy has demonstrated complete response rates of approximately 0.6–4% in metastatic TNBC across KEYNOTE studies, and even the most active approved agents—such as sacituzumab govitecan—have reported complete response rates of only ~2–4% in large Phase 2 and Phase 3 trials.
In this setting, any radiologic finding consistent with an immune-complete response (iCR), even prior to confirmatory imaging, represents a highly unusual event which stands out relative to historical benchmarks for metastatic TNBC. These data may suggest enhanced biological activity of the combination regimen and warrant continued follow-up under iRECIST guidelines.
"Observing an initial complete response in a patient with metastatic triple-negative breast cancer is an extremely encouraging clinical finding," said Dr. John Friend, Chief Executive Officer of Kazia Therapeutics. "Although this is a single expanded-access case and requires confirmatory imaging, the depth of response aligns closely with our mechanistic hypothesis that paxalisib may meaningfully enhance anti-tumor immunity when combined with checkpoint blockade. This outcome further energizes our Phase 1b program in advanced breast cancer and complements significant progress across our broader pipeline."
Q4 BUSINESS UPDATE
1. Kazia Announces upcoming presentations related to paxalisib and NDL2 programs
Kazia is pleased to announce the acceptance of two scientific presentations at the 2025 Brisbane Cancer Conference, scheduled to take place on 27–28 November 2025 in Brisbane, Australia.
The Brisbane Cancer Conference is a premier oncology meeting that brings together leading international researchers, clinicians and industry experts working in the fields of translational oncology, molecular medicine and cellular therapeutics.
The following presentations will take on November 27, 2025:
"From bench to bedside: targeting epigenetic pathways to overcome metastasis and immunotherapy resistance in TNBC" – Sudha Rao, PhD, QIMR Berghofer (Australia)
Epigenetic checkpoint blockade: A new booster to enhance immunogenicity" Sherry Tu, PhD, QIMR Berghofer (Australia)
Kazia is proud to announce acceptance of two scientific presentations at the 2025 San Antonio Breast Cancer Symposium (SABCS) to be held December 10–14, 2025. SABCS is the largest and most influential breast cancer meeting globally, drawing more than 10,000 international experts in clinical oncology, translational science, immunotherapy, and molecular diagnostics.
December 10, 2025 — PS2-10-02
"Liquid Biopsy Tracking of PI3K-mTOR Residual Disease Signatures in Metastatic Breast Cancer", Presenter: Prof. Sudha Rao, QIMR Berghofer (Australia)
December 12, 2025 — PS5-08-04
"A Phase 1b, Multi-Centre, Open-Label, Randomized Study to Evaluate the Safety, Tolerability, and Clinical Activity of Combining Paxalisib with Olaparib or Pembrolizumab/Chemotherapy in Patients with Advanced Breast Cancer", Presenter: Dr. Michelle Nottage, The Royal Brisbane and Women's Hospital (Australia)
"SABCS is the pinnacle global meeting for breast cancer research. Being selected for two presentations is both an honor and a strong validation of our scientific direction," stated Dr. Friend.
2. NDL2 PD-L1 Degrader Program: Advancing Toward IND-Enabling Studies anticipated in Early 2026
As announced in September 2025, Kazia entered into a collaboration and licensing agreement with QIMR Berghofer covering the first in class NDL2 PD-L1 degrader program. PD-L1 degraders represent the next frontier in immuno-oncology, using a dual-mechanism approach is designed to specifically recognize and degrade the resistant, post-translationally modified forms of the PD-L1 protein. This strategy may address resistance mechanisms that limit current checkpoint inhibitors. Kazia expects to initiate IND-enabling preclinical studies in early 2026.
3. GBM Program: Advancing Toward a FDA Type C Meeting Request Following Strong Overall Survival Signals
As detailed in the October 24, 2025 press release, Kazia intends to request a follow-up Type C meeting with the FDA to discuss the overall survival paxalisib findings from our completed clinical studies, alignment with the Project FrontRunner framework, potential requirements for a confirmatory study, and elements needed for a possible NDA submission pathway for paxalisib in newly diagnosed glioblastoma.
"We believe paxalisib's OS data strongly justify continued engagement with the FDA and may support a more efficient regulatory strategy under Project FrontRunner," stated Dr. Friend.
4. As previously disclosed, Kazia received a notice (the "Notice") from the Listing Qualifications department (the "Staff") of The Nasdaq Stock Market LLC ("Nasdaq") on May 12, 2025 notifying the Company that from March 28, 2025 to May 9, 2025, the Company's Market Value of Listed Securities ("MVLS") was below the minimum of $35 million required for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(b)(2) (the "MVLS Requirement"). In accordance with Nasdaq Listing Rule 5810(c)(3)(C), Nasdaq provided the Company with 180 calendar days, or until November 10, 2025 to regain compliance with the MVLS Requirement.
On November 12, 2025, Kazia received a staff determination letter ("Staff Letter") from the Staff of Nasdaq indicating that the Company had not regained compliance with the MVLS Requirement by November 10, 2025. Pursuant to the Nasdaq Listing Rules and the Staff Letter, unless the Company timely requests a hearing before a Hearings Panel (the "Panel"), the Company's American Depositary Shares would be subject to suspension/delisting . The Staff Letter has no immediate effect on listing or trading, and the Company intends to timely request a hearing before the Panel, which will automatically stay any suspension or delisting action pending the outcome of the hearing. The Company believes there are remedies available to potentially stop the proceedings and is evaluating corporate and market-based options, including alternative Nasdaq equity requirements to regain compliance.
For investor and media, please contact Alex Star, Managing Director LifeSci Advisors LLC, Astarr @W. Mark-786-8795.
About Kazia Therapeutics
Kazia Therapeutics Limited (NASDAQ: KZIA) is an oncology-focused drug development company, based in Sydney, Australia. Our lead program is paxalisib, an investigational brain penetrant inhibitor of the PI3K / Akt / mTOR pathway, which is being developed to treat multiple forms of cancer. Licensed from Genentech in late 2016, paxalisib is or has been the subject of ten clinical trials in this disease. A completed Phase 2/3 study in glioblastoma (GBM-Agile) was reported in 2024 and discussions are ongoing for designing and executing a pivotal registrational study in pursuit of a standard approval. Other clinical trials involving paxalisib are ongoing in advanced breast cancer, brain metastases, diffuse midline gliomas, and primary central nervous system lymphoma, with several of these trials having reported encouraging interim data. Paxalisib was granted Orphan Drug Designation for glioblastoma by the U.S. Food and Drug Administration (FDA) in February 2018, and Fast Track Designation (FTD) for glioblastoma by the FDA in August 2020. Paxalisib was also granted FTD in July 2023 for the treatment of solid tumor brain metastases harboring PI3K pathway mutations in combination with radiation therapy. In addition, paxalisib was granted Rare Pediatric Disease Designation and Orphan Drug Designation by the FDA for diffuse intrinsic pontine glioma in August 2020, and for atypical teratoid / rhabdoid tumors in June 2022 and July 2022, respectively. Kazia is also developing EVT801, a small molecule inhibitor of VEGFR3, which was licensed from Evotec SE in April 2021. Preclinical data has shown EVT801 to be active against a broad range of tumor types and has provided evidence of synergy with immuno-oncology agents. A Phase I study has been completed and preliminary data was presented at 15th Biennial Ovarian Cancer Research Symposium in September 2024. For more information, please visit www.kaziatherapeutics.com or follow us on X @KaziaTx.
Forward-Looking Statements
This announcement contains forward-looking statements, which can generally be identified as such by the use of words such as "may," "will," "plan," "intend," "estimate," "future," "forward," "potential," "anticipate," or other similar words. Any statement describing Kazia's future plans, strategies, intentions, expectations, objectives, goals or
subslover
1年前
Kazia Therapeutics Announces Transformative Preclinical Data Demonstrating Paxalisib's Potential to Overcome Immunotherapy Resistance in Triple-Negative Breast Cancer (TNBC)
SYDNEY, June 11, 2025 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), a clinical-stage biotechnology company pioneering next-generation oncology therapeutics, today announced the publication of transformative preclinical research in the journal Molecular Cancer Therapeutics, a journal of the American Association for Cancer Research that underscores the powerful potential of its lead asset, paxalisib, in reshaping the treatment landscape for triple-negative breast cancer (TNBC), one of the most aggressive and treatment-resistant cancer subtypes.
The preclinical program was conducted by Professor Sudha Rao at the renowned QIMR Berghofer Medical Research Institute, revealing how paxalisib can reprogram the tumor microenvironment and enhance immune response, showing substantial synergy with immune checkpoint inhibitors. The data provide strong scientific and translational rationale for continued development of paxalisib as part of immunotherapy-based regimens.
Key Findings
Dual targeting of PI3K and mTOR but not PI3K alone inhibits cancer cell proliferation and migration in vitro.
Paxalisib remodels the TNBC tumor microenvironment, increasing CD4+ and CD8+ T cell infiltration and activation
The combination of paxalisib with KEYTRUDA® (pembrolizumab) demonstrated synergistic antitumor activity in advanced breast cancer, resulting in robust tumor regression and prolonged survival in preclinical models
The data validate a mechanistic rationale for ongoing clinical exploration of paxalisib in combination with checkpoint inhibitors and PARP inhibitors
"This landmark study offers a mechanistic and translational foundation for our newly launched Phase 1b clinical trial of paxalisib in advanced breast cancer," said Dr. John Friend, CEO of Kazia. "It not only extends the therapeutic potential of paxalisib beyond brain cancers but also positions it at the forefront of innovative immunotherapy combinations in solid tumors."
The publication, "Combination of the PI3K/mTOR inhibitor paxalisib with immune checkpoint inhibitors enhances antitumor activity in preclinical models of triple-negative breast cancer," is available online at https://aacrjournals.org/mct/article/doi/10.1158/1535-7163.MCT-24-0693/762929/Depleting-the-action-of-EZH2-through-PI3K-mTOR.
Clinical Milestone
Kazia recently announced that the first patient has been dosed in the Phase 1b trial evaluating paxalisib in combination with checkpoint inhibitors and chemotherapy in advanced breast cancer, marking a critical step toward clinical translation of these findings.
For investor and media, please contact Alex Star, Managing Director LifeSci Advisors LLC
About Kazia Therapeutics Limited
Kazia Therapeutics Limited (NASDAQ: KZIA) is an oncology-focused drug development company, based in Sydney, Australia. Our lead program is paxalisib, an investigational brain penetrant inhibitor of the PI3K / Akt / mTOR pathway, which is being developed to treat multiple forms of brain cancer. Licensed from Genentech in late 2016, paxalisib is or has been the subject of ten clinical trials in this disease. A completed Phase 2/3 study in glioblastoma (GBM-Agile) was reported in 2024 and discussions are ongoing for designing and executing a pivotal registrational study in pursuit of a standard approval. Other clinical trials involving paxalisib are ongoing in brain metastases, diffuse midline gliomas, and primary CNS lymphoma, with several of these trials having reported encouraging interim data. Paxalisib was granted Orphan Drug Designation for glioblastoma by the FDA in February 2018, and Fast Track Designation (FTD) for glioblastoma by the FDA in August 2020. Paxalisib was also granted FTD in July 2023 for the treatment of solid tumour brain metastases harboring PI3K pathway mutations in combination with radiation therapy. In addition, paxalisib was granted Rare Pediatric Disease Designation and Orphan Drug Designation by the FDA for diffuse intrinsic pontine glioma in August 2020, and for atypical teratoid / rhabdoid tumours in June 2022 and July 2022, respectively. Kazia is also developing EVT801, a small molecule inhibitor of VEGFR3, which was licensed from Evotec SE in April 2021. Preclinical data has shown EVT801 to be active against a broad rang
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