Kairos Pharma Reports Positive Interim Phase 2 Results for ENV-105 in Advanced Prostate Cancer

Kairos Pharma announced positive interim Phase 2 data showing ENV-105 combined with apalutamide achieved clinical benefit in 86% of metastatic castration-resistant prostate cancer patients, potentially addressing treatment resistance in advanced disease.

October 20, 2025
Kairos Pharma Reports Positive Interim Phase 2 Results for ENV-105 in Advanced Prostate Cancer

Kairos Pharma Ltd. (NYSE American: KAPA) reported positive interim efficacy data from its ongoing Phase 2 trial of ENV-105 in men with metastatic castration-resistant prostate cancer, showing significant clinical benefit and potential for restoring hormone responsiveness. The data, presented at the European Society for Medical Oncology meeting in Berlin, demonstrated that 86% of patients treated with ENV-105 combined with apalutamide experienced clinical benefit, with all responders remaining progression-free for at least four months and half beyond one year.

The study results revealed that seven of nine evaluable patients experienced PSA reductions, supporting the therapy's potential to overcome treatment resistance in advanced prostate cancer. The randomized trial, led by Cedars-Sinai and partner institutions, continues to enroll patients to further evaluate safety and long-term efficacy. ENV-105, also known as carotuximab, represents a novel approach to cancer treatment by targeting CD105, a protein identified as a key driver of resistance to various cancer treatments.

The significance of these findings lies in addressing the critical challenge of treatment resistance in metastatic castration-resistant prostate cancer, where patients often exhaust standard therapeutic options. The ability of ENV-105 to potentially restore hormone responsiveness could provide a new treatment pathway for patients facing limited alternatives. The company's latest news and updates are available in their newsroom at https://ibn.fm/KAPA.

Kairos Pharma's approach utilizes structural biology to overcome drug resistance and immune suppression in cancer, with ENV-105 designed to reverse drug resistance by targeting CD105 and restoring the effectiveness of standard therapies. The elevation of CD105 in response to standard therapy typically results in resistance and disease relapse, making this targeted approach particularly relevant for advanced cancer patients. Beyond the current prostate cancer trial, ENV-105 is also in a Phase 1 trial for lung cancer, addressing significant unmet medical needs across multiple cancer types.

The interim results suggest that ENV-105 could represent an important advancement in the treatment of advanced prostate cancer, particularly for patients who have developed resistance to standard therapies. The combination approach with apalutamide appears to enhance therapeutic effectiveness, potentially offering new hope for patients with limited treatment options. The continued enrollment in the Phase 2 trial will provide additional data on the long-term benefits and safety profile of this innovative treatment approach.