Kairos Pharma, Ltd. (NYSE American: KAPA) announced positive safety results from its ongoing Phase 2 clinical trial of ENV-105 (carotuximab) in patients with metastatic castration-resistant prostate cancer (mCRPC). The interim safety analysis covered the first ten enrolled patients in the trial.
The analysis demonstrated that ENV-105, a first-in-class CD105 antagonist, was well tolerated when combined with standard of care hormone therapy, apalutamide. No dose-limiting toxicities or unexpected adverse events were reported to date, and treatment-related side effects were manageable with standard supportive care.
Notably, no Grade 3 or 4 toxicities were observed in the study. This favorable safety profile validates Kairos Pharma's belief in ENV-105’s clinical potential and supports its continued development in a patient population with limited effective treatment options. Interim efficacy data from the trial are expected to be reported in September 2025.
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