Kairos Pharma Reports Promising Phase II Data for ENV105 in mCRPC

Kairos Pharma has shared encouraging interim results from its Phase II study evaluating ENV105 (carotuximab), a CD105 antagonist, in men with metastatic castration-resistant prostate cancer (mCRPC) who had progressed after at least one hormone therapy.

A predefined analysis included ten patients from the trial’s safety arm. Two patients withdrew due to reasons unrelated to the study, leaving eight evaluable participants. Among them, median progression-free survival (PFS) exceeded 13 months, with five patients continuing without disease progression. Seven of nine patients showed reductions in prostate-specific antigen levels.

ENV105 was administered in combination with apalutamide, yielding a median PFS surpassing the trial’s target of 6.7 months—a 45% improvement over standard second- or third-line hormone therapy, which typically shows 3.7 months PFS.

The ongoing randomized Phase II study plans to enroll 100 participants across US centers, assessing safety, tolerability, and preliminary efficacy. Earlier safety analyses indicated the combination was well tolerated.

22-09-2025