On July 28, 2026 Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused biotechnology company developing therapies that reprogram cancer biology, restore anti-tumor immunity and overcome treatment resistance, reported the filing of a provisional patent application supporting a novel therapeutic strategy designed to prevent metastatic recurrence in patients with high-risk early-stage triple-negative breast cancer (TNBC).

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The patent filing is supported by new preclinical findings from a model designed to replicate high-risk early-stage TNBC. In the model, standard treatment —neoadjuvant chemotherapy, anti-PD-1 immunotherapy and surgical resection — followed by adjuvant paxalisib reduced residual disease and local recurrence by 95% (p<0.0001) and lung metastatic burden by 40% (p<0.027).

Complementary translational studies were conducted on ex vivo tumor samples from patients with high-risk, early-stage TNBC. In these studies, paxalisib completely disrupted (100%) the circulating tumor cell (CTC) clusters that were detected. Together with emerging clinical observations from the Company’s ongoing metastatic TNBC study, these findings strengthen the translational rationale for advancing paxalisib across multiple stages of disease.

A New Strategy to Prevent Metastatic Recurrence

Approximately one-third of patients with Stage II/III TNBC continue to have residual disease following standard perioperative therapy and remain at high risk of metastatic recurrence. Current development strategies in this setting are primarily focused on intensifying tumor cell killing through additional cytotoxic therapies and antibody-drug conjugates.

Preventing metastatic recurrence could require more than eliminating residual tumor cells. It may also require targeting the biological programs that allow those surviving cells to evade immune surveillance, disseminate and establish metastatic disease.

Paxalisib represents a differentiated tumor and immune reprogramming strategy designed to potentially intervene before metastatic relapse becomes clinically established.

"For decades, oncology has largely focused on treating metastatic disease once it appears. The next frontier is preventing metastasis before it begins," said Dr. John Friend II, Chief Executive Officer of Kazia Therapeutics. "Residual disease represents the population of tumor cells most capable of driving future metastatic relapse. Our new preclinical findings, together with encouraging translational observations from patients receiving paxalisib-based therapy, support a differentiated strategy focused on reprogramming tumor biology, restoring anti-tumor immunity and preventing metastatic recurrence. We believe these data significantly expand the potential opportunity for paxalisib beyond advanced disease and establish a strong scientific and intellectual property foundation for future development in high-risk early breast cancer."

Building on Emerging Clinical Momentum

The Company’s ongoing Phase Ib study evaluating paxalisib in combination with pembrolizumab (Keytruda) and chemotherapy in advanced metastatic TNBC generated encouraging preliminary clinical and translational findings, including objective tumor responses with disruption of CTC clusters.

Kazia believes the convergence of these patient observations with the newly generated perioperative preclinical data strengthens the rationale for advancing paxalisib across multiple stages of TNBC, from advanced metastatic disease to earlier intervention aimed at reducing residual disease and preventing metastatic recurrence.

Given these findings, the Company is actively evaluating opportunities to broaden the clinical development of paxalisib into earlier-stage TNBC and expects to provide additional details regarding its development strategy in the near term.

(Press release, Kazia Therapeutics, JUL 28, 2026, View Source [SID1234669460])