Kairos Pharma Ltd. (NYSE American: KAPA) is broadening its Phase 2 clinical trial for ENV105, a therapy targeting drug resistance in cancer, with the addition of City of Hope Cancer Center and Huntsman Cancer Institute to the study. The multi-center trial is evaluating ENV105 in patients with castrate-resistant prostate cancer.
The Phase 2 trial is designed to assess the efficacy of ENV105 in combination with apalutamide, a common hormone therapy, versus apalutamide alone. The study aims to address the significant challenge of hormone therapy resistance that often develops in prostate cancer patients. The trial is supported by both Kairos Pharma and a grant from the National Cancer Institute (NCI).
Addressing Hormone Therapy Resistance in Prostate Cancer
Hormone therapy is a standard treatment for prostate cancer, but resistance inevitably emerges, leading to disease progression. ENV105, a monoclonal antibody, targets CD105, a protein implicated in driving resistance to various cancer treatments. Preclinical data suggests that ENV105 blocks a central mechanism of hormone therapy resistance.
Dr. Neil Bhowmick, Chief Scientific Officer of Kairos Pharma, stated, "The preclinical findings suggest that ENV105 blocks a central mechanism of hormone therapy resistance. We are encouraged that we have multiple peer-reviewed articles in addition to receiving an NCI grant that supports the solid science behind this trial."
Trial Design and Objectives
The randomized trial will enroll patients receiving either apalutamide or apalutamide+ENV105 combination therapy. The addition of multiple centers will allow Kairos Pharma to test ENV105 in a broader patient population and identify blood markers that could help select patients expected to benefit most from ENV105 treatment.
"Multiple sites allow Kairos Pharma to test ENV105 in a broader patient population to identify blood markers that could help select patients expected to benefit most from ENV105 treatment, and the reputation of Huntsman only serves to elevate the study among the medical community," said Dr. Bhowmick.
Leadership Perspective
Kairos CEO Dr. John Yu added, "This is an important milestone in our mission to develop first-in-class approaches to address the inevitable resistance that develops in prostate cancer patients receiving hormone therapy, as it provides additional validation for the science behind ENV105."
About ENV105
ENV105 is Kairos Pharma's lead candidate, designed to reverse drug resistance by targeting CD105 and restore the effectiveness of standard therapies across multiple cancer types. It is currently in a Phase 2 clinical trial for castrate-resistant prostate cancer and a Phase 1 trial for lung cancer.
