Kazia Therapeutics (KZIA) said Tuesday that data showed its paxalisib therapy significantly reduced tumor burden and the total amount of cancer in the body by 52% in a preclinical model of microsatellite stable/proficient mismatch repair colorectal cancer.
The company said that in a separate study, adding paxalisib to an existing immunotherapy drug reduced tumor volume by an additional 50%, relative to immunotherapy alone. The treatment was well tolerated in both studies, with no evidence of treatment-related toxicity, according to the company.
Kazia said it plans to launch a five-arm phase 2 clinical trial evaluating paxalisib as a monotherapy in combination with pembrolizumab compared with standard of care in pre-treated microsatellite stable/proficient mismatch repair metastatic colorectal cancer.
The primary endpoint of the study will be safety and tolerability, while progression-free survival, overall response rate, and overall survival will be secondary endpoints.
Enrollment in the trial is expected to begin in Q1 2027, with full enrollment expected by the end of the year, the company added.
Kazia shares were up 2.5% in Tuesday's premarket activity.
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