#Australia #Sydney #Kazia Therapeutics #Paxalisib #Advanced Breast Cancer

Kazia Therapeutics Begins Phase 1b Trial with Paxalisib

On June 5, 2025, Kazia Therapeutics Limited, a biotechnology firm specializing in oncology, announced a significant milestone: the commencement of patient dosing in a Phase 1b clinical trial for paxalisib, aimed at treating advanced breast cancer. This trial is particularly noteworthy as it aims to assess paxalisib in combination with established therapies, which could reshape treatment protocols for patients suffering from this debilitating disease.

Trial Overview

The Phase 1b trial sponsored by Kazia Therapeutics marks the initial foray of paxalisib beyond its previous applications in brain cancer, expanding its reach into broader solid tumor contexts. Paxalisib functions as a dual PI3K/mTOR inhibitor, which aligns with recent clinical trends that underscore the importance of combining therapies to enhance patient outcomes.

The trial, designated as an open-label, randomized study, is set to evaluate both the safety and tolerability of various treatment combinations. Furthermore, it will perform extensive biomarker profiling to gather foundational data for future developmental endeavors and to identify early indicators of clinical activity.

Dr. John Friend, CEO of Kazia, emphasized the significance of this trial in diversifying the therapeutic applications of paxalisib. According to Dr. Friend, the study is built upon compelling preclinical findings that have indicated promising results regarding epigenetic modulation in aggressive breast cancer models. By utilizing dual inhibition strategies, this trial aspires to explore innovative methods to combat tumor metabolism and immune evasion, addressing one of the most critical challenges in oncology today.

Treatment Arms of the Trial

The trial will include two main arms:

• - Arm A: Patients in this group will receive either 15mg or 30mg of paxalisib daily alongside olaparib (300mg orally, twice daily) within 28-day cycles.
• - Arm B: Patients will take either dosage of paxalisib in synergy with pembrolizumab (200mg IV every 21 days). This arm will also include standard chemotherapy options like nanoparticle albumin-bound paclitaxel or a gemcitabine-carboplatin regimen, contingent on specific clinical indications.

Participants will undergo assessment for several critical factors:

• - Tolerability and occurrence of adverse events
• - Changes in circulating tumor cells (CTCs) and their clusters
• - Evaluation of immune cell signatures and overall immune functionality
• - Clinical activity and tumor response indicators

Strategic Importance

This trial signifies not just a clinical advancement but also a strategic enlargement of the market position for Kazia. It expands the clinical usage of paxalisib from solely targeting brain cancers to a broader audience of solid tumors. This opens up vast commercial opportunities, especially for advanced and metastatic breast cancers, notably including triple-negative variants.

Moreover, for prospective partners and acquirers, the trial’s innovative biomarker-driven design presents an early examination of how paxalisib could augment or sensitize tumors to immune checkpoint inhibitors and therapies aimed at DNA repair.

From a scientific viewpoint, the structured nature of the study aims to produce translational data that may elucidate the interactions between dual PI3K/mTOR inhibition, immune modulation, and chemotherapy effects, potentially leading to enhanced treatment strategies.

Conclusion

Kazia's advancement into this Phase 1b trial represents a hopeful beacon in the quest for effective breast cancer therapies. As the study unfolds, interim updates will likely provide key insights into the potential capabilities of paxalisib, promising a new direction for patients facing the grim realities of advanced breast cancer. Kazia’s commitment to harnessing differentiated science and collaborative partnerships reflects a broader ambition to improve the landscape of cancer therapies, especially for indications that currently present poor prognoses.

For media inquiries and further information on Kashia’s developments, you can visit their official website at Kazia Therapeutics.