Kairos Pharma Announces Positive Safety Results for ENV-105 in Advanced Prostate Cancer Trial

Kairos Pharma has reported positive safety results from a Phase 2 trial of ENV-105 in advanced prostate cancer patients. The interim analysis showed that ENV-105, a CD105 antagonist, was well-tolerated when combined with standard hormone therapy. No dose-limiting toxicities or unexpected adverse events were reported, and treatment-related side effects were manageable. The trial aims to enroll 100 patients and is currently accruing patients at three centers. Interim efficacy data is expected in September 2025.

Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused on innovative cancer therapeutics, 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 of the trial demonstrated that ENV-105, a first-in-class CD105 antagonist, was well tolerated when combined with standard of care hormone therapy, apalutamide, from the first ten enrolled patients. Thus far, there have been no dose-limiting toxicities or unexpected adverse events reported to date. In addition, the treatment-related side effects were manageable with standard supportive care. Notably, no Grade 3 or 4 toxicities were observed [1].

The randomized Phase 2 trial aims to enroll 100 patients in total, and is presently accruing patients at Cedars-Sinai Medical Center, City of Hope, and Huntsman Cancer Center. The study is designed to evaluate the safety, tolerability, and early signs of efficacy of ENV-105 in men whose disease has progressed following standard hormone-based therapies. Interim efficacy data from the trial are expected to be reported in September 2025 [1].

Kairos Pharma plans to engage with regulatory agencies to discuss the design of a potential pivotal Phase 3 study, based on emerging data. The company seeks to provide a safe and effective alternative for patients with mCRPC, a growing unmet need with an increasingly aging population. Castration-resistant prostate cancer refers to tumors that grow despite receiving hormone blocking agents. Treatment options remain limited after hormone therapies fail [1].

References:
[1] https://www.stocktitan.net/news/KAPA/kairos-pharma-announces-positive-safety-results-from-phase-2-trial-ggkchsqnrowl.html