Kairos Pharma Ltd., a clinical-stage biopharmaceutical company, has announced positive safety results from its ongoing Phase 2 clinical trial of ENV-105 (carotuximab) for patients with metastatic castration-resistant prostate cancer. The interim safety analysis revealed that the CD105 antagonist, when combined with standard hormone therapy apalutamide, was well tolerated by the first ten patients enrolled in the study. No dose-limiting toxicities or unexpected adverse events were reported, and treatment-related side effects were manageable. No Grade 3 or 4 toxicities were observed. The trial, which aims to enroll 100 patients, is currently accruing participants at multiple locations including Cedars-Sinai Medical Center. Interim efficacy data is expected in September 2025. Kairos Pharma is planning to discuss the design of a potential pivotal Phase 3 study with regulatory agencies based on emerging data.