ENV-105 (carotuximab) in combination with Apalutamide

October 6, 2026: Kairos Pharma, Ltd. (NYSE: KAPA) reported positive interim Phase 2 data for ENV-105 (carotuximab) plus apalutamide in metastatic castration-resistant prostate cancer. In the ongoing trial, median progression-free survival was 17.7 months for ENV-105 plus apalutamide versus 2 months for apalutamide alone, with a statistically significant difference (P=0.0008).

Based on the interim efficacy signal, the company amended the Phase 2 protocol to treat patients earlier in disease progression. Instead of enrolling patients after one or two anti-androgen agents, the revised study will enroll patients with PSA increase after upfront treatment with an androgen signaling inhibitor, and randomize them to enzalutamide alone or enzalutamide plus ENV-105.

Kairos said the change is intended to broaden eligibility and support enrollment, with Phase 2 completion targeted in or before Q4 2027.

ENV-105 is described as a first-in-class CD105 antibody being studied to address resistance to standard hormone therapy in metastatic prostate cancer. Trial sites include Cedars-Sinai Medical Center, City of Hope, and Huntsman Cancer Institute at the University of Utah.