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SYDNEY - Kazia Therapeutics (NASDAQ:KZIA) announced preliminary results from the first patient in its Phase 1b trial evaluating a combination of its drug paxalisib with pembrolizumab (Keytruda) and standard chemotherapy in metastatic triple-negative breast cancer. For investors tracking breakthrough developments in the biotech sector, InvestingPro offers comprehensive analysis and real-time updates on emerging pharmaceutical companies and their clinical trials.
According to the company’s press release statement, the 61-year-old female patient with lung metastasis showed a greater than 50% reduction in circulating tumor cells (CTCs) and a notable decrease in CTC clusters after 21 days of treatment (one cycle).
The company indicated that these early findings align with preclinical research published in Molecular Cancer Therapeutics, which demonstrated that paxalisib combined with immunotherapy disrupted both single CTCs and multicellular clusters in laboratory models.
"The degree of reduction in tumor cell dissemination markers in just 21 days gives us strong reason for optimism as we continue this clinical trial," said Dr. John Friend, Chief Executive Officer of Kazia Therapeutics, in the announcement.
The company noted that CTC clusters are associated with increased metastatic potential, and that standard chemotherapy sometimes temporarily increases CTC counts before normalizing after additional treatment cycles.
Kazia reported that the combination regimen also reduced the mesenchymal phenotype of remaining CTCs, which the company described as a characteristic of aggressive cancer cells.
The Phase 1b trial is continuing enrollment to assess safety, tolerability, and pharmacodynamics of the combination treatment. The company plans to explore potential relationships between CTC measurements and radiographic responses as the study progresses.
Paxalisib is an investigational brain-penetrant inhibitor of the PI3K/Akt/mTOR pathway that has received various FDA designations, including Orphan Drug Designation for glioblastoma and Fast Track Designation for solid tumor brain metastases with PI3K pathway mutations when combined with radiation therapy. Investors seeking deeper insights into healthcare investment opportunities can access advanced screening tools and expert analysis through InvestingPro’s comprehensive stock screener, which includes specialized filters for biotech companies and their development pipelines.
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