On October 20, 2025 Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused on innovative cancer therapeutics, reported on the positive interim efficacy data from its ongoing Phase 2 clinical trial of ENV-105 (carotuximab) in patients with metastatic castration-resistant prostate cancer (mCRPC) at the annual European Society Medical Oncologists meeting in Berlin, Germany.
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An interim efficacy analysis from the ongoing trial with ENV-105, a first-in-class CD105 antagonist, is being tested for safety and early efficacy in men with metastatic prostate cancer resistant to standard hormone therapy. Despite progression on prior hormonal therapies, the trial showed clinical benefit when combining ENV-105 with hormone therapy, apalutamide, in 86% of treated patients. All responders remained progression-free for at least four months and half remained progression-free beyond one year. Notably, seven of nine evaluable patients experienced a reduction in PSA levels from baseline.
"The positive safety profile and initial clinical benefit we’ve seen through our extensive interim analysis validates the comprehensive mechanism of action studies that preceded this clinical study, demonstrating how ENV-105 restores a patient’s ability to respond to hormone therapy," said Dr. Neil Bhowmick, CSO of Kairos Pharma.
Edwin Posadas, Director of the Experimental Therapeutics Program and the Medical Director of the Center for Uro-Oncology Research Excellence at the Cedars-Sinai Cancer Institute, leads the randomized Phase 2 trial that is currently accruing up to 100 patients at Cedars-Sinai Medical Center, City of Hope Cancer Center, and the Huntsman Cancer Institute. The 13.7 median PFS (progression free survival) achieved by imaging with the ENV-105 and apalutamide combination reported would suggest an improvement over current alternatives of chemotherapy and radioligand therapy, in terms of disease control as well as tolerability. Kairos Pharma seeks to provide a safe and effective therapy with ENV-105 for the over 3 million men with hormone-resistant prostate cancer worldwide.
(Press release, Kairos Pharma, OCT 20, 2025, View Source [SID1234656843])