Durable Complete Metabolic Response Ongoing Since November 2025
All Evaluable Sufferers Demonstrated Reductions in Metastasis-Connected CTC Clusters and Terminally Exhausted T cells, With Median Reductions of 83% and 51% Respectively
No Treatment-Connected Serious Negative Events Noticed
SYDNEY, Aug. 27, 2026 /PRNewswire/ — Kazia Therapeutics Runt (NASDAQ: KZIA) (“Kazia” or the “Firm”), an oncology-centered biotechnology firm increasing therapies that selectively reprogram most cancers biology, restore anti-tumor immunity and overcome remedy resistance, as of late launched new data showing its lead asset, paxalisib, finished a 100% scientific relief rate in six evaluable patients with Stage IV triple-detrimental breast most cancers (TNBC). Five of the six patients finished an aim response – a measurable 30% or bigger reduction in tumor burden after remedy – including one total response and 4 partial responses, main to an aim response rate of 83 percent. The final patient finished exact illness. Importantly, these outcomes had been finished with the comfort of oral dosing and a top safety and tolerability profile, without a paxalisib-related serious detrimental events and no grade 3 or bigger hyperglycemia, stomatitis or mucositis, toxicities many times related to PI3K/mTOR pathway inhibition.
“Metastatic triple-detrimental breast most cancers is one among the hardest cancers to treat. Traditionally, handiest 12 percent of patients are alive five years after prognosis. Once a patient’s illness progresses on immunotherapy, alternate suggestions trudge out rapid,” acknowledged Dr. John Buddy, CEO, Kazia Therapeutics. “Across the six evaluable patients handled, every body of them has benefited, and we haven’t seen a single serious detrimental event tied to paxalisib. We’ve also demonstrated most necessary enhancements in terminally exhausted T cells and drastic reductions in circulating tumor cell (CTC) clusters, providing early evidence that paxalisib would per chance per chance be addressing natural mechanisms related to remedy resistance and metastasis. These outcomes toughen our self belief in this program as we continue enrollment within the Share 1b trial.”
Medical responses had been noticed across a wide vary of metastatic illness sites, including lung, liver, bone, lymph node and central apprehensive arrangement purpose lesions, with responses emerging as early as roughly three months put up-randomization. Most particularly, a 44-yr-outmoded lady with Stage IV TNBC finished a total metabolic response and has had no evidence of illness since November 2025. Her response has remained durable by means of the most modern overview and has been accompanied by sustained and total abolishment of CTC clusters and necessary reduction in terminally exhausted CD8+ T cells, alongside overall enchancment in markers of immune map.
Translational analyses demonstrated reductions in terminally exhausted CD8+ T cells across all six patients, with a median reduction of 51 percent within roughly three weeks of remedy. These cells signify a dysfunctional inhabitants of cytotoxic T cells that has lost its skill to acknowledge and abolish most cancers cells. Seriously, whole CD8+ T cell counts remained unchanged, which suggests that paxalisib isn’t eradicating these exhausted cells or changing them with new ones. As a replace, the prevailing cells seem to be regaining map. Blood-essentially based simultaneous multi-modal protein, RNA and plasma profiling supported this discovering, demonstrating increases in immune cell populations related to anti-tumor declare, reductions in markers of immune exhaustion and evidence of PI3K-AKT pathway purpose engagement. The marker findings present evidence of improved overall immune map across all patients.
In parallel with the immune adjustments, all six patients demonstrated reductions in circulating tumor cell clusters, which are aggressive groupings of tumor cells within the bloodstream related to metastatic unfold. The median reduction was 83 percent within six to seven weeks of remedy.
“Two of the supreme challenges in treating triple-detrimental breast most cancers are the dormant most cancers cells that unfold by means of the bloodstream, and an immune arrangement too exhausted to fight them. It’s uncommon to search a remedy affect both at the identical time. After years of studying this illness, it’s difficult to behold this in a scientific surroundings. The circulating tumor cell clusters that seed new metastases are being suppressed, while the exhausted T cells desired to fight the most cancers are recovering map and showing indicators of immune memory, that would per chance per chance translate to tougher responses. These adjustments within the blood are monitoring with what we are seeing on the scans, which suggests our liquid biopsy methodology would per chance per chance be taking pictures both the tumor’s metastatic behavior and the immune arrangement’s response to remedy in exact time. It affords us a noteworthy window into the illness, and we verify ahead to building on these findings as the trial progresses,” acknowledged Dr. Sudha Rao, Chief Scientific Officer, Kazia Therapeutics.
These early natural findings signify what would per chance per chance be a first-in-class attain and counsel that paxalisib’s therapeutic attain would per chance per chance extend past cytoplasmic PI3K/mTOR inhibition. The rapid and consistent natural responses noticed across all evaluable patients enhance the hypothesis that paxalisib would per chance per chance exert dual affect by restoring immune map and reducing metastatic dissemination, addressing two of the most intelligent challenges within the remedy of triple-detrimental breast most cancers and traditional drivers of most cancers development.
Enrollment within the Firm’s ongoing Share 1b obtain out about evaluating paxalisib along with pembrolizumab (Keytruda®) and chemotherapy in stepped forward metastatic TNBC is anticipated to be finished by July 2027, with intervening time scientific updates anticipated one day of 2026 and 2027.
About Kazia Therapeutics
Kazia Therapeutics Runt (NASDAQ: KZIA ) is an oncology-centered drug development firm, essentially based in Sydney, Australia. The Firm’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 most cancers. Licensed from Genentech in late 2016, paxalisib is or has been the topic of over 15 scientific trials. A finished Share 2/3 obtain out about in glioblastoma (GBM AGILE) was reported in 2024, and discussions are ongoing for designing and executing a pivotal registrational obtain out about in pursuit of a outmoded approval. Other scientific trials difficult paxalisib are ongoing in stepped forward breast most cancers, brain metastases, diffuse midline gliomas, and first central apprehensive arrangement lymphoma, with quite loads of of those trials having reported encouraging intervening time data. Paxalisib was granted Orphan Drug Designation for glioblastoma by the U.S. Meals and Drug Administration (FDA) in February 2018, and Snappily Discover Designation (FTD) for glioblastoma in August 2020. Paxalisib was also granted FTD in July 2023 for the remedy of exact tumor brain metastases harboring PI3K pathway mutations along with radiation therapy. Furthermore, paxalisib was granted Uncommon Pediatric Disease Designation and Orphan Drug Designation by the FDA for diffuse intrinsic pontine glioma in August 2020 and for abnormal teratoid / rhabdoid tumors in June 2022 and July 2022, respectively. Kazia will be increasing EVT801, a miniature molecule inhibitor of VEGFR3, which was licensed from Evotec SE in April 2021. Along with its scientific-stage capabilities, Kazia is advancing NDL2, a per chance first-in-class intracellular PD-L1 protein degrader program concentrated on a newly identified mechanism of immunotherapy resistance and metastatic development, as well to MSETC, a per chance first-in-class SETDB1 inhibitor program intended to revive immune signaling in tumors that salvage become resistant to immunotherapy, including checkpoint inhibitors. Both capabilities are within the intervening time in preclinical development. For more data, please talk about to www.kaziatherapeutics.com or declare us on X @KaziaTx.
Ahead-Looking out Statements
This announcement would per chance per chance beget forward-taking a verify statements, that would per chance per chance most incessantly be identified as such by the usage of words corresponding to “would per chance per chance,” “will,” “estimate,” “future,” “forward,” “not sleep for,” “rely on,” “arrangement,” “command,” “doable,” or a form of identical words. Any assertion describing Kazia’s future plans, suggestions, intentions, expectations, objectives, objectives or prospects, and a form of statements that must not historical facts, are also forward-taking a verify statements, including, but not dinky to, statements concerning: the aptitude of paxalisib to provide scientific relief, including aim responses, to patients with stepped forward triple-detrimental breast most cancers; the preliminary and intervening time nature of the scientific, translational and biomarker data described in this announcement, and expectations concerning the sturdiness of any noticed responses; the aptitude for future data to alter preliminary and preliminary outcomes from this early-stage scientific trial, which is in accordance with a miniature decision of patients and isn’t designed or powered to point to statistical significance; the aptitude of paxalisib to revive anti-tumor immune map and prick metastasis-associated circulating tumor cell clusters; the flexibility of translational and biomarker findings to foretell scientific outcomes; the timing completion of enrollment in, and anticipated intervening time updates from, the Firm’s ongoing Share 1b obtain out about of paxalisib along with pembrolizumab and chemotherapy in stepped forward metastatic TNBC; and the timing and roar of future public disclosures concerning the Firm’s scientific capabilities and development technique.
Such statements are in accordance with Kazia’s most contemporary expectations and projections about future events and future inclinations affecting its industry and are topic to determined dangers and uncertainties that would motive right outcomes to fluctuate materially from those anticipated within the forward-taking a verify statements, including dangers and uncertainties related to: the reach of early-stage therapeutic capabilities; the conduct of scientific trials, including the flexibility to signal up patients and slay anticipated enrollment targets; the preliminary nature of preclinical data, that would per chance per chance not be predictive of scientific ends in humans; the preliminary nature of recordsdata from miniature, launch-impress scientific evaluation, which are in accordance with a miniature decision of patients and isn’t going to be predictive of ends in an even bigger patient inhabitants or in later-stage or final scientific trials; dangers related to regulatory approvals; dangers related to Kazia’s reliance on third-celebration collaborators and scientific trial sites; dangers related to the Firm’s skill to rating, address and provide protection to its intellectual property, including the uncertainty of patent prosecution and the aptitude for third-celebration challenges; dangers related to the affect of worldwide financial prerequisites; and dangers related to Kazia’s skill to address compliance with the appropriate NASDAQ endured list requirements and standards. These and a form of dangers and uncertainties are described more utterly in Kazia’s Annual Document on Impression 20-F filed with the SEC, and in subsequent filings with the United States Securities and Alternate Commission. Kazia undertakes no obligation to publicly update any forward-taking a verify assertion, whether as a outcomes of new data, future events, or in another case, except as required under appropriate law. You mustn’t spot undue reliance on these forward-taking a verify statements, which discover handiest as of the date of this announcement.
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