Kairos Pharma to Present Promising Phase 2 Prostate Cancer Data Highlighting Carotuximab’s Potential to Overcome Hormone Therapy Resistance at ESMO 2025
Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused on developing novel cancer therapeutics that address treatment resistance, announced today that it has been selected to present pivotal data at the upcoming European Society for Medical Oncology (ESMO) Congress 2025. The company’s presentation, titled “Preliminary safety and clinical activity from a Phase 2 study of apalutamide and carotuximab in advanced, castration-resistant prostate cancer,” will be featured during the conference taking place in Berlin, Germany, from October 17–21, 2025.
The inclusion of Kairos Pharma’s Phase 2 data at one of the most prestigious oncology meetings in the world underscores the growing scientific interest in ENV105 (carotuximab), a first-in-class CD105 antagonist designed to overcome resistance mechanisms in advanced prostate cancer. This presentation marks an important milestone for Kairos as it seeks to validate its approach of combining novel molecular targeting with existing standard-of-care therapies.
Addressing a Major Challenge in Prostate Cancer Therapy
Prostate cancer remains one of the most commonly diagnosed cancers in men worldwide and continues to be a leading cause of cancer-related mortality. In the United States alone, more than one million new cases are diagnosed each year, and thousands of patients progress to advanced stages despite receiving frontline androgen deprivation therapy (ADT) or androgen receptor (AR)-targeted agents such as enzalutamide, apalutamide, or abiraterone.
For patients with metastatic castration-resistant prostate cancer (mCRPC), treatment options become increasingly limited once resistance to androgen-targeted therapy develops. This resistance often results from tumor adaptations in the microenvironment and activation of alternative growth pathways that sustain disease progression even in low-androgen conditions.
Kairos Pharma’s research is focused on addressing precisely this resistance. ENV105 (carotuximab) is designed to inhibit CD105 (endoglin), a co-receptor involved in TGF-β signaling that plays a key role in tumor angiogenesis, metastasis, and resistance to standard cancer therapies. By targeting CD105, Kairos aims to disrupt the tumor microenvironment and resensitize cancer cells to anti-androgen therapies, ultimately improving patient outcomes.
Details of the Phase 2 Study
The ongoing Phase 2 trial of ENV105 (ClinicalTrials.gov Identifier: NCT05534646) is a randomized, multicenter study enrolling 100 men with metastatic castration-resistant prostate cancer who have progressed on prior androgen-targeted therapies. The study is being conducted across three leading U.S. cancer centers: Cedars-Sinai Medical Center, City of Hope, and the Huntsman Cancer Institute at the University of Utah.
Participants are randomized to receive apalutamide—an established androgen receptor inhibitor—either alone or in combination with ENV105. The primary objectives of the trial are to assess safety, tolerability, and preliminary efficacy, with secondary endpoints including progression-free survival (PFS), prostate-specific antigen (PSA) response rates, radiographic response, and biomarkers of resistance modulation.
The interim analysis, which will be presented at ESMO 2025, evaluates early safety outcomes and initial signals of clinical activity. According to Kairos Pharma, preliminary results demonstrate encouraging tolerability and early signs of antitumor efficacy, providing a strong rationale for continued development and possible expansion into later-stage trials.
Early Findings Show Promise
Neil Bhowmick, PhD, Chief Scientific Officer of Kairos Pharma and principal investigator of the study, expressed optimism regarding the data to be presented at ESMO.
“The data we will be presenting at the 2025 ESMO Congress demonstrate encouraging safety and early efficacy findings from our Phase 2 trial,” said Dr. Bhowmick. “This is an important venue for us to share the therapeutic potential of ENV105 for patients with few remaining treatment options after hormone therapy resistance develops.”
While detailed efficacy metrics remain embargoed until presentation, Kairos Pharma indicated that combination therapy with ENV105 and apalutamide was generally well tolerated, with manageable side effects consistent with the known safety profile of each agent. Early indications suggest potential synergistic activity, as evidenced by PSA declines and radiographic improvements in several patients receiving the combination regimen.
These findings, though preliminary, highlight the possibility that targeting CD105-mediated signaling may represent a novel approach to overcoming therapy resistance in mCRPC—a domain where treatment innovation has been sorely needed.
The Scientific Rationale: CD105 and the Tumor Microenvironment
CD105 (endoglin) is a transmembrane glycoprotein highly expressed on proliferating endothelial cells within the tumor vasculature. It modulates TGF-β signaling, which governs cell growth, differentiation, and angiogenesis. Elevated CD105 expression has been associated with aggressive disease behavior, poor prognosis, and resistance to chemotherapy and radiation in various solid tumors, including prostate cancer.
By blocking CD105, carotuximab (ENV105) interferes with angiogenic signaling and may restore normal vascular function, improving the delivery and efficacy of co-administered therapies. In preclinical studies, ENV105 has shown the ability to disrupt aberrant tumor vasculature, reduce metastatic potential, and enhance the activity of androgen receptor inhibitors.
This mechanism positions ENV105 as a potential “microenvironment modulator,” offering a complementary strategy to traditional approaches that target cancer cells directly. Such dual targeting—tumor-intrinsic and microenvironmental—represents a next-generation paradigm in oncology, where understanding and manipulating the tumor’s supportive ecosystem is increasingly recognized as essential to achieving durable clinical responses.
Kairos Pharma’s Broader Vision and Pipeline
Beyond prostate cancer, Kairos Pharma is advancing a pipeline of targeted oncology programs designed to overcome resistance mechanisms in difficult-to-treat tumors. The company’s discovery platform integrates insights from tumor biology, stromal interactions, and immune modulation to identify new therapeutic combinations that enhance the effectiveness of existing treatments.
ENV105 represents the company’s lead asset and embodies its philosophy of “amplifying the efficacy of the standard of care.” Kairos’s research strategy focuses on leveraging established therapies while introducing novel agents that can counteract the resistance mechanisms limiting their long-term benefit.
According to the company, its future plans include expanding clinical evaluation of ENV105 into earlier disease settings and potentially in combination with immunotherapy or radioligand approaches, which are becoming increasingly relevant in prostate cancer management.
Participation at ESMO 2025: A Global Scientific Platform
The European Society for Medical Oncology (ESMO) Congress is one of the most influential annual meetings in global cancer research, bringing together oncologists, researchers, and industry leaders to share cutting-edge clinical data and scientific breakthroughs. Kairos Pharma’s selection to present its Phase 2 trial findings at this event marks a significant recognition of the company’s research credibility and the potential impact of ENV105 in prostate cancer therapy.
By engaging with the international oncology community at ESMO, Kairos aims not only to share data but also to foster collaborations that could accelerate the next phase of clinical development. The company’s participation reflects its commitment to scientific transparency, data-driven innovation, and patient-centered advancement in oncology.
Looking Ahead: Next Steps for ENV10
With promising safety and preliminary efficacy signals emerging from the ongoing Phase 2 trial, Kairos Pharma is planning for continued patient enrollment and data collection through 2026. The company anticipates that updated results, including more mature efficacy data and biomarker analyses, will help define the optimal clinical path forward.
If the favorable trends observed so far are confirmed in the final analysis, Kairos may pursue a pivotal Phase 3 trial, potentially positioning ENV105 as the first therapy to specifically target CD105 in combination with an androgen receptor inhibitor for mCRPC. Such an advancement could meaningfully expand the treatment landscape for men who have exhausted standard hormonal options.
The company’s broader goal is to demonstrate that targeting the tumor microenvironment can transform outcomes not only in prostate cancer but also across multiple solid tumor indications where resistance remains a key obstacle.
About Kairos Pharma
Kairos Pharma, Ltd. is a clinical-stage biopharmaceutical company dedicated to developing targeted therapies for cancer patients with high unmet medical needs. The company’s mission is to advance safe, effective, and science-driven solutions that enhance the efficacy of existing treatments and overcome therapeutic resistance mechanisms.
With a pipeline anchored by ENV105 and other novel agents in preclinical and early clinical development, Kairos is positioned at the forefront of innovation in tumor microenvironment research. By focusing on molecular mechanisms of resistance, Kairos seeks to redefine the standards of treatment durability and improve survival outcomes for patients facing aggressive and treatment-resistant cancers.
For more information, visit www.kairospharma.com.
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These include statements about the expected progress, success, and future development of Kairos Pharma’s clinical programs, including ENV105. Forward-looking statements are based on current expectations and projections and are not guarantees of future performance.
Actual results could differ materially due to various risks and uncertainties, including but not limited to: the success and completion of the Phase 2 trial, the initiation and completion of future clinical trials, regulatory approval processes, and commercial viability. Readers are advised to review Kairos Pharma’s filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K, for a more comprehensive discussion of these risks.
Kairos Pharma undertakes no obligation to update or revise any forward-looking statements, except as required by applicable law.
Kairos Pharma’s upcoming presentation at ESMO 2025 represents a pivotal moment in the company’s pursuit to redefine therapeutic strategies for metastatic castration-resistant prostate cancer. The promising early results from its Phase 2 trial of ENV105 (carotuximab) in combination with apalutamide offer new hope for patients who have exhausted standard options.
By targeting the tumor microenvironment through CD105 inhibition, Kairos is charting a path toward potentially overcoming one of oncology’s most stubborn challenges—treatment resistance. As the oncology community gathers in Berlin to discuss the future of cancer therapy, Kairos’s data will stand as a testament to the power of scientific innovation aimed at turning resistance into renewed responsiveness.
