Kairos Pharma Announces Promising Interim Results for ENV-105 in Advanced Prostate Cancer Trial

Kairos Pharma (NYSE: KAPA) has revealed positive interim efficacy data from its Phase 2 trial of ENV-105 for metastatic castration-resistant prostate cancer (mCRPC). The findings, presented at the European Society for Medical Oncology (ESMO) meeting, suggest a significant clinical benefit when ENV-105, a CD105 antagonist, is combined with the standard therapy apalutamide.

The ongoing study demonstrated that the combination therapy provided a clinical benefit in 86% of patients. Participants in the trial experienced durable progression-free survival, with a majority showing meaningful reductions in prostate-specific antigen (PSA) levels. These results highlight the biological activity of ENV-105 and its potential to restore hormonal sensitivity in patients who have stopped responding to standard treatments.

Notably, all patients who responded to the treatment remained progression-free for a minimum of four months. Half of these responders maintained disease control for over a year. The interim analysis reported a median progression-free survival of 13.7 months, indicating that the ENV-105 regimen could offer a significant advantage in managing the disease compared to other treatments like chemotherapy or radioligand therapy. The combination also maintained a favorable safety profile, avoiding additional toxicity.

These findings are significant for the more than three million men worldwide affected by hormone-resistant prostate cancer, a condition with limited long-term treatment options. ENV-105’s ability to extend disease control without compromising patient safety could establish it as a valuable alternative or addition to current treatment protocols. By potentially resensitizing tumors to hormonal therapy, ENV-105 could change the treatment landscape for advanced prostate cancer.

The study is being conducted by leading research institutions, including Cedars-Sinai Cancer Institute, City of Hope, and Huntsman Cancer Institute. It continues to enroll patients, with a target of up to 100 participants.

The presentation at ESMO has increased the visibility of ENV-105 within the oncology community, which may attract interest in partnerships or strategic collaborations. Kairos Pharma is expected to complete enrollment for the Phase 2 trial within the next year. The company anticipates releasing updated efficacy and safety data in 2026 as it moves ENV-105 toward later-stage development, marking a critical next step for this promising cancer therapy.

About Kairos Pharma 

Kairos Pharma is a clinical-stage biopharmaceutical company committed to developing innovative therapies that combat drug resistance and immune suppression in cancer patients. Our mission is to push the boundaries of medical science and improve outcomes for those facing the toughest battles.

To find out more information please visit www.kairospharma.com.