Kairos Pharma, Ltd. (NYSE American: KAPA) announced on October 6, 2026, that its ongoing Phase 2 clinical trial evaluating ENV-105 (carotuximab) in combination with apalutamide has demonstrated positive interim efficacy data for patients with metastatic castration-resistant prostate cancer (mCRPC).
The interim analysis revealed a statistically significant difference in progression-free survival (PFS) between the combination therapy and apalutamide alone. The data indicates a median PFS of 17.7 months for patients treated with ENV-105 plus apalutamide, compared to 2 months for those treated with apalutamide alone (P=0.0008).
In response to these findings, the company has modified the Phase 2 protocol. The updated protocol will enroll patients earlier in the course of disease progression, specifically those who experience a PSA increase following upfront treatment with an androgen signaling inhibitor. Patients will now be randomized to receive either enzalutamide alone or enzalutamide in combination with ENV-105. The company stated it aims to complete the Phase 2 trial in or before the fourth quarter of 2027.
The trial is being conducted at Cedars-Sinai Medical Center, City of Hope, and Huntsman Cancer Institute at the University of Utah. ENV-105 is a first-in-class antibody targeting CD105, a protein identified as a key driver of drug resistance and disease relapse.
