Kairos Pharma, Ltd., a clinical-stage biopharmaceutical company pioneering innovative cancer therapeutics, announced today it will host a virtual Key Opinion Leader (KOL) event on Thursday, September 18 at 5:00 p.m. ET / 2:00 p.m. PT. The event will spotlight interim efficacy results from the Company’s ongoing Phase 2 clinical trial of ENV105, its lead candidate for the treatment of advanced prostate cancer.
The webcast will feature perspectives from leading oncology experts who will discuss the significance of the interim data, the therapeutic potential of ENV105, and the broader challenges in treating advanced and drug-resistant prostate cancers. Registration is required to access the webcast.
CEO Commentary
“The safety results of the trial are an important catalyst as we prepare to share the interim efficacy analysis of ENV105 in patients with advanced prostate cancer,” said Dr. John Yu, CEO of Kairos Pharma. “This evaluation was conducted four months after the initiation of combination therapy with ENV105 and apalutamide in the last safety lead-in patient. Our aim is to demonstrate both the clinical need filled by ENV105 and the compound’s potential benefits. We believe this panel of distinguished experts will provide valuable insights into how ENV105 could address drug resistance in prostate cancer and reshape treatment expectations.”
Featured Speakers
The KOL event will bring together a panel of experts with deep experience in prostate cancer research and treatment:
- Dr. Neil Bhowmick, President and Chief Scientific Officer, Kairos Pharma
- Dr. Umang Swami, Associate Professor, Division of Oncology, Department of Internal Medicine, Huntsman Cancer Institute
- Dr. Richard Lee, Clinical Co-Director, The Claire and John Bertucci Center for Genitourinary Cancers, Massachusetts General Hospital, Harvard Medical School
- Dr. Edwin Posadas, Director, Experimental Therapeutics Program and Medical Director, Center for Uro-Oncology Research Excellence, Samuel Oschin Comprehensive Cancer Institute
Together, the panel will discuss ENV105’s mechanism of action, trial progress, and the implications of the interim results for patients and the oncology community.
Trial Background and Interim Safety Data
ENV105 is a first-in-class CD105 antagonist, designed to target pathways involved in tumor resistance to existing therapies. In prostate cancer, CD105 has been linked to disease progression and treatment failure, making it a novel and promising therapeutic target.
The interim safety analysis, released in July 2025, evaluated the first 10 patients enrolled in the Phase 2 study. Results showed that ENV105, when combined with standard-of-care hormone therapy apalutamide, was well tolerated with no dose-limiting toxicities or unexpected adverse events. Side effects observed were manageable with standard supportive care, and no Grade 3 or 4 toxicities were reported. These findings support continued investigation into ENV105’s efficacy in addressing resistance to hormone therapies.
The Urgent Need in Prostate Cancer
Prostate cancer remains one of the most prevalent cancers worldwide, with over one million men diagnosed annually in the United States alone. Despite advances in hormone therapy, many patients eventually develop castration-resistant prostate cancer (CRPC)—a stage of disease where tumors progress despite treatment with androgen-blocking agents. Once resistance emerges, therapeutic options become limited, underscoring the urgent need for novel mechanisms and more effective therapies.
By developing ENV105, Kairos Pharma aims to fill this critical treatment gap. The company’s approach is to combine innovation in molecular targeting with clinically meaningful outcomes that improve both survival and quality of life for patients with advanced disease.
Looking Ahead
With interim safety data already demonstrating tolerability and the upcoming presentation of efficacy results, ENV105 is positioned as a potentially transformative therapy for men with advanced, drug-resistant prostate cancer. Kairos Pharma believes that ENV105 could establish a new treatment paradigm, especially for patients whose disease continues to progress despite available hormone therapies.
“Castration-resistant prostate cancer represents one of the greatest ongoing challenges in oncology,” added Dr. Yu. “ENV105 has the potential to offer a safe and effective treatment option for patients with few alternatives, and we are excited to engage the medical community through this KOL event to discuss the significance of our interim findings.”
Event Access
The KOL event will be held virtually on September 18, 2025, at 5:00 p.m. ET / 2:00 p.m. PT. Interested participants must register in advance to access the webcast. A replay of the event will be made available on Kairos Pharma’s website following the live session.
About Kairos Pharma, Ltd.
Based in Los Angeles, California, Kairos Pharma Ltd. (NYSE American: KAPA) aims to work at the forefront of oncology therapeutics, utilizing structural biology to overcome drug resistance and immune suppression in cancer. Our lead candidate, ENV105, is an antibody that targets CD105 – a protein identified as a key driver of resistance to various cancer treatments.
Elevation of CD105 in response to standard therapy results in resistance and disease relapse. ENV105 aims to reverse drug resistance by targeting CD105 and restore the effectiveness of standard therapies across multiple cancer types. Currently, ENV105 is in a Phase 2 clinical trial for castrate-resistant prostate cancer and a Phase 1 trial for lung cancer aimed at addressing significant unmet medical needs. For more information, visit kairospharma.com.
