Kazia Therapeutics Announces Regulatory Approval for Clinical Trial of Novel Breast Cancer Treatment
Sydney, Australia, January 30, 2025 – Kazia Therapeutics Limited, a leading oncology-focused drug development company, is thrilled to announce that regulatory approval has been granted for the commencement of a clinical trial evaluating the combination of paxalisib and immunotherapy in patients with advanced breast cancer. This innovative treatment approach is believed to offer a unique solution for targeting this highly aggressive and treatment-resistant form of the disease.
About Kazia Therapeutics and Paxalisib
Kazia Therapeutics is a clinical-stage biotechnology company dedicated to the research and development of novel oncology therapies. The company’s lead compound, paxalisib, is a potent and selective inhibitor of PI3Kδ, a key signaling protein in the PI3K/mTOR pathway. This pathway is frequently activated in various types of cancer, including breast cancer, and contributes to tumor growth, survival, and resistance to treatment.
Combining Paxalisib with Immunotherapy
Immunotherapy has revolutionized cancer treatment in recent years, harnessing the power of the patient’s own immune system to attack cancer cells. However, some types of breast cancer, particularly triple-negative breast cancer (TNBC), are highly aggressive and treatment-resistant, making them difficult to treat with immunotherapy alone. Kazia Therapeutics believes that the combination of paxalisib and immunotherapy may address this challenge by inhibiting the PI3K/mTOR pathway, which is known to contribute to immune evasion and resistance in breast cancer.
Clinical Trial Details
The Phase 1/2 clinical trial, known as KTX-1831-G001, will be conducted at multiple sites in the United States and Australia. The study will evaluate the safety, tolerability, and efficacy of the combination of paxalisib and an anti-PD-L1 checkpoint inhibitor in patients with advanced or metastatic TNBC. The primary endpoints of the study are safety, objective response rate, and progression-free survival.
Impact on Patients
For patients with advanced or metastatic TNBC, the approval of this clinical trial represents a potential new hope for effective treatment. Triple-negative breast cancer is particularly aggressive and difficult to treat, with limited therapeutic options available. The combination of paxalisib and immunotherapy may offer a more comprehensive approach to targeting this disease, potentially leading to improved outcomes for patients.
Impact on the World
Breast cancer is the most common cancer among women worldwide, and TNBC accounts for approximately 15% of all breast cancer diagnoses. The inadequacy of current treatment options for TNBC highlights the urgent need for innovative approaches to address this disease. The results of this clinical trial could lead to a new standard of care for treating TNBC, potentially benefiting millions of women worldwide.
Conclusion
Kazia Therapeutics’ announcement of regulatory approval for the KTX-1831-G001 clinical trial evaluating the combination of paxalisib and immunotherapy in patients with advanced breast cancer represents a significant step forward in the fight against this aggressive and treatment-resistant form of the disease. The potential benefits of this novel treatment approach could positively impact the lives of millions of women worldwide, and the results of the clinical trial are eagerly anticipated.
- Kazia Therapeutics Limited announces regulatory approval for clinical trial of paxalisib and immunotherapy in advanced breast cancer
- Paxalisib is a potent and selective inhibitor of PI3Kδ, a key signaling protein in the PI3K/mTOR pathway
- Combining paxalisib with immunotherapy may address the challenge of treating triple-negative breast cancer
- Clinical trial, KTX-1831-G001, will evaluate safety, tolerability, and efficacy of combination therapy in patients with advanced or metastatic TNBC
- Potential new hope for patients with limited therapeutic options for advanced or metastatic TNBC
- Results of the clinical trial could lead to a new standard of care for treating TNBC, benefiting millions of women worldwide
