Kazia Therapeutics Updates on TNBC Clinical Trial Progress
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 27 2026
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Should l Buy KZIA?
Kazia Therapeutics provided a clinical update from its ongoing Phase 1b study evaluating paxalisib in combination with pembrolizumab and chemotherapy in patients with late-stage, metastatic triple-negative breast cancer, or TNBC. To date, three patients with metastatic TNBC treated with paxalisib-based regimens have demonstrated meaningful clinical responses, including two partial responses in trial participants and one confirmed complete metabolic response in a patient treated under an expanded access program. 2 of 2 evaluable patients enrolled in the Phase 1b trial achieved partial responses. One advanced metastatic TNBC patient achieved a confirmed complete metabolic response following re-treatment with pembrolizumab/chemotherapy plus paxalisib. Responses observed in patients with visceral disease and multi-organ metastases. Median time on treatment to date is approximately 6.1 months, with all patients continuing on therapy at the time of this update. Paxalisib continues to demonstrate a generally favorable safety and tolerability profile when combined with pembrolizumab and chemotherapy at the 30 mg daily dose. Approximately 75% of adverse events were assessed as unlikely or unrelated to paxalisib. The paxalisib-related AEs were expected and predominantly mild to moderate, consistent with prior studies. The company expects to activate two additional clinical sites by April 2026, with two further sites planned for mid-2026. Kazia continues to anticipate the targeted enrollment of twelve TNBC pts target by the end of 2026 and topline data readout in early 2027.
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Analyst Views on KZIA
Wall Street analysts forecast KZIA stock price to rise
2 Analyst Rating
2 Buy
0 Hold
0 Sell
Moderate Buy
Current: 8.220
Low
18.00
Averages
19.00
High
20.00
Current: 8.220
Low
18.00
Averages
19.00
High
20.00
About KZIA
Kazia Therapeutics Limited is an Australia-based pharmaceutical drug development company. The Company operates in the pharmaceutical research and development business. The Company’s 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. It is also developing EVT801, a small-molecule inhibitor of VEGFR3, which is critical to the development of new blood vessels and lymphatic vessels in a growing tumor, as well as to the metastasis of tumors to distant sites in the body. It designed paxalisib to inhibit PI3K, a critical control mechanism in growth and cell division, which is activated in many forms of cancer. The Company’s drug candidates are designed to treat diseases, such as brain cancer, renal cancer, and liver cancer.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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See More
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See More
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- Combined Therapy Effectiveness: When combined with anti-PD-1 therapy, NDL2 reduced primary tumor volume by 73%, indicating that this combination therapy has significant potential to enhance anti-tumor activity and improve patient outcomes.
- Positive Results in Lung Metastasis Patients: In patients with lung metastases, the combination of NDL2 and anti-PD-1 therapy resulted in a 50% reduction in primary tumor volume, providing new hope for treating metastatic cancer and potentially altering clinical treatment strategies.
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See More
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- Significant Efficacy Data: In murine triple-negative breast cancer models, NDL2 reduced primary tumor volume by 49% as monotherapy and 73% in combination with anti-PD-1, demonstrating its robust anti-tumor activity.
- Safety and Pharmacokinetics: NDL2 showed no toxicity in preclinical trials, preserving immune checkpoint function at the cell surface, indicating its potential safety and efficacy in clinical applications.
- Future Development Outlook: Kazia plans to initiate first-in-human clinical trials in 2027 targeting immunotherapy-refractory solid tumors, with NDL2's development expected to create strategic partnership opportunities and long-term value.
See More
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- Clinical Trial Progress: Kazia Therapeutics reports significant clinical responses in its ongoing Phase 1b trial for late-stage metastatic triple-negative breast cancer, with three patients showing meaningful responses, including two partial responses and one complete metabolic response, indicating the potential of paxalisib.
- Funding Support: In December 2025, Kazia raised approximately $46.5 million to support the continued clinical development of paxalisib, with plans to enroll twelve TNBC patients by the end of 2026, further advancing its research efforts.
- Safety and Tolerability: Paxalisib, when combined with pembrolizumab and chemotherapy at a daily dose of 30 mg, has demonstrated a favorable safety profile, with only one case of Grade 1 hyperglycemia observed, requiring no intervention, suggesting a relatively low risk for this treatment regimen.
- Future Plans: Kazia anticipates activating two additional clinical sites by April 2026, with plans for two more by mid-2026, aiming to accelerate patient recruitment and target topline data readout in early 2027, showcasing its strategic positioning in breast cancer treatment.
See More
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- Significant Clinical Responses: In the ongoing Phase 1b trial, three patients with late-stage metastatic triple-negative breast cancer treated with paxalisib demonstrated meaningful clinical responses, including two partial responses and one confirmed complete metabolic response, indicating the potential efficacy of this therapy.
- Trial Design and Patient Selection: This multi-center, open-label randomized study, initiated in June 2025, aims to evaluate the safety and preliminary efficacy of paxalisib in combination with standard treatment regimens, with eligibility requiring PD-L1 positive disease, ensuring scientific rigor and clinical relevance.
- Adverse Event Monitoring: Approximately 75% of adverse events reported during treatment were assessed as unrelated to paxalisib, with most being mild to moderate, demonstrating the drug's good tolerability and laying a foundation for future clinical applications.
- Future Development Plans: Kazia plans to activate two additional clinical trial sites by April 2026 and anticipates enrolling 12 patients by the end of 2026, further advancing paxalisib's application in broader breast cancer populations, showcasing the company's long-term commitment to this field.
See More
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- Strategic Conference Participation: Kazia Therapeutics CEO John Friend will attend the J.P. Morgan Healthcare Conference next week in San Francisco to connect with existing and prospective investors and strategic partners, thereby enhancing the company's investor relations and business development efforts.
- Post-Financing Momentum: Following a successful financing round, Kazia is well-capitalized to execute on multiple near-term catalysts, including an anticipated clinical and biomarker update for triple-negative breast cancer (TNBC) by the end of the month, which will enhance the company's competitiveness in oncology.
- Clinical Update Expectations: Kazia expects to provide an update on its ongoing Phase 1b trial for TNBC by the end of January, potentially including expanded analyses of circulating tumor cells (CTCs) and CTC clusters, thereby supporting paxalisib's potential impact on metastatic disease biology with more clinical data.
- New Drug Development Progress: Kazia plans to provide the first update on its potential first-in-class PD-L1 protein degrader program, aimed at leveraging a novel mechanism to address challenges in immune-based cancer therapies, further advancing the company's innovative capabilities in cancer treatment.
See More
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- Clinical Data Breakthrough: Oncolytics' pelareorep achieved a 33% objective response rate in second-line KRAS-mutant microsatellite-stable metastatic colorectal cancer patients when combined with standard chemotherapy, significantly surpassing the historical 6-11% response rate for chemotherapy alone, potentially driving growth in a $20 billion market.
- Enhanced Expert Validation: Oncolytics expanded its Gastrointestinal Tumor Scientific Advisory Board with three globally recognized experts, further elevating the academic validation and industry attention for pelareorep, which may attract more investment and collaboration opportunities.
- Successful FDA Alignment: Oncolytics has secured FDA alignment on its Phase 3 study design for pelareorep in first-line metastatic pancreatic cancer, marking the launch of the only immunotherapy registration trial planned for this disease, thereby enhancing its market competitiveness.
See More
