Kairos Pharma reports positive interim PFS data for ENV-105 in prostate cancer trial

Kairos Pharma, Ltd. (NYSE American: KAPA) announced on October 6, 2026 that it received positive interim efficacy data from its ongoing Phase 2 trial testing ENV-105, also known as carotuximab, in combination with apalutamide in patients with metastatic castration-resistant prostate cancer, finding a statistically significant difference in progression-free survival between patients who received the combination and those given apalutamide alone.¹

The company reported that median progression-free survival was 17.7 months with the combination compared with 2 months with apalutamide alone (P=0.0008).¹

Based on this interim signal, Kairos Pharma has modified the Phase 2 protocol to enroll patients earlier in disease progression, shifting from treatment after one or two anti-androgen agents to enrollment of patients who show a PSA increase following initial treatment with an androgen signaling inhibitor; these patients will be randomized to enzalutamide alone or enzalutamide combined with ENV-105.¹ The company said the protocol change is meant to widen the eligible patient pool and speed enrollment, with a target of completing the Phase 2 trial by the fourth quarter of 2027.¹

CEO John Yu said the interim results "provide an important clinical signal for ENV-105 and support our strategy of targeting the mechanisms underlying drug resistance."¹

The release describes ENV-105 as targeting CD105, which the company has identified as a protein that drives resistance and disease relapse following standard therapy, forming the basis for testing ENV-105 alongside standard cancer treatments.¹ The trial is titled a study of ENV-105, described as "a first-in-class CD105 antibody,"¹ and enrollment has taken place at Cedars-Sinai Medical Center, City of Hope and Huntsman Cancer Institute at the University of Utah.¹