Kairos Pharma Reports Positive Phase 2 Results for ENV105 in Advanced Prostate Cancer

Kairos Pharma Ltd. (NYSE American: KAPA) has released a comprehensive update on its clinical progress and 2026 outlook through a shareholder letter from CEO John Yu, M.D. The company reported significant positive interim results from its Phase 2 trial evaluating ENV105 in combination with apalutamide for advanced metastatic prostate cancer. The data demonstrated clinical benefit in 86% of treated patients, with durable progression-free survival observed across the study population and no dose-limiting toxicities reported.

The findings, which were presented at the European Society for Medical Oncologists Meeting, indicate that ENV105 may extend the effectiveness of standard care while maintaining excellent tolerability. This combination approach represents a potential advancement in treating castrate-resistant prostate cancer, a condition with limited therapeutic options. Kairos continues to actively recruit patients for the trial, with enrollment expected to reach 100 participants across leading U.S. cancer centers. The company maintains its newsroom at https://ibn.fm/KAPA where investors can access the latest updates.

ENV105 represents a novel approach in cancer therapeutics as an antibody targeting CD105, a protein identified as a key driver of resistance to various cancer treatments. The elevation of CD105 in response to standard therapy often results in resistance and disease relapse, making it a critical target for overcoming treatment limitations. By targeting CD105, ENV105 aims to reverse drug resistance and restore the effectiveness of standard therapies across multiple cancer types.

Beyond the prostate cancer program, ENV105 is also being evaluated in a Phase 1 trial for lung cancer, addressing another area of significant unmet medical need. The company's approach utilizes structural biology to overcome drug resistance and immune suppression in cancer, positioning Kairos at the forefront of oncology therapeutic development. The positive safety profile observed in the Phase 2 trial is particularly noteworthy given the challenging patient population being treated for advanced metastatic disease.

The clinical progress outlined in the shareholder letter underscores Kairos Pharma's commitment to developing innovative cancer treatments that address fundamental mechanisms of treatment resistance. The combination strategy of ENV105 with established therapies like apalutamide represents a pragmatic approach to improving patient outcomes while leveraging existing treatment paradigms. As patient enrollment continues and additional data emerges, the medical community awaits further validation of these promising early results in advanced prostate cancer treatment.