Kairos Pharma Surges 165% on Positive Phase 2 Safety Data for Prostate Cancer Therapy ENV-105
Kairos Pharma Ltd. (NYSE: KAPA) jumped 165% after reporting encouraging interim safety data from its Phase 2 trial evaluating ENV-105 in combination with apalutamide (Erleada) for patients with metastatic castration-resistant prostate cancer (mCRPC).
The analysis, based on the first ten patients enrolled, showed that ENV-105—a novel CD105 antagonist—was well tolerated with no dose-limiting toxicities, no unexpected adverse events, and no Grade 3 or 4 toxicities. Treatment-related side effects were manageable with standard supportive care.
Dr. John Yu, CEO of Kairos Pharma, stated, “The favorable safety profile observed in this Phase 2 study validates our belief in ENV-105’s potential and supports continued development in a patient population with limited treatment options.”
The ongoing randomized trial plans to enroll 100 patients and is currently recruiting at Cedars-Sinai Medical Center, City of Hope, and Huntsman Cancer Institute. The study is designed to compare ENV-105 plus Erleada versus Erleada alone in patients who have progressed following prior hormone therapy. The primary endpoint is progression-free survival (PFS), and interim efficacy data is expected in September 2025.
Analysts at Maxim Group reiterated their Buy rating on Kairos following the news, citing ENV-105’s potential to re-sensitize tumors to anti-androgen therapy. They view a 4-month PFS benchmark as a potential proof of concept. Prior Phase 2 data pairing ENV-105 with Xtandi showed a 62% clinical benefit rate in resistant patients.
ENV-105 targets CD105, a protein involved in tumor angiogenesis and drug resistance. By blocking CD105, the therapy may help restore sensitivity to standard treatments in prostate cancer and potentially other solid tumors. Maxim Group assigns a 12-month price target of $4.00 for KAPA shares, factoring in future commercialization of ENV-105 in mCRPC by 2030.
