Kairos Pharma Ltd. Reports Positive Safety Results in Phase 2 Study of Prostate Cancer Drug ENV-105

Kairos Pharma Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company specializing in cancer therapies, has reported positive interim safety results from its ongoing Phase 2 trial of ENV-105 (carotuximab) in patients with metastatic castration-resistant prostate cancer. The study, which is being conducted at prestigious institutions including Cedars-Sinai, City of Hope, and Huntsman Cancer Center, has shown that ENV-105, a first-in-class CD105 antagonist, was well tolerated in combination with apalutamide, a standard hormone therapy. Notably, no dose-limiting toxicities or unexpected adverse events were observed in the first ten patients, and there were no reports of Grade 3 or 4 toxicities.

The significance of these findings cannot be overstated, as they suggest that ENV-105 could offer a safer treatment option for patients with metastatic castration-resistant prostate cancer, a condition with limited effective therapies. The interim efficacy data, expected in September 2025, will provide further insights into the drug's potential. Kairos Pharma plans to engage with regulatory authorities regarding a potential Phase 3 study, which could pave the way for ENV-105 to become a new standard of care in prostate cancer treatment.

ENV-105 targets CD105, a protein implicated in resistance to various cancer treatments. By inhibiting CD105, ENV-105 aims to overcome drug resistance and restore the efficacy of standard therapies. This mechanism of action positions ENV-105 as a promising candidate not only for prostate cancer but also for other cancer types where CD105 plays a role in treatment resistance. The ongoing Phase 2 trial for castrate-resistant prostate cancer and a Phase 1 trial for lung cancer underscore Kairos Pharma's commitment to addressing unmet medical needs in oncology.

The positive safety profile of ENV-105 in the Phase 2 trial is a beacon of hope for patients and healthcare providers alike. It represents a critical milestone in the development of novel cancer therapies that are both effective and tolerable. As the medical community eagerly awaits the interim efficacy results, the potential impact of ENV-105 on the treatment landscape for prostate cancer and beyond is immense. For more information on Kairos Pharma and its innovative approach to cancer therapy, visit https://www.KairosPharma.com.