Kairos Pharma Reports Positive Phase 2 ENV-105 Data

LOS ANGELES — October 6, 2026

ENV-105 Demonstrates Statistically Significant PFS Signal

The interim Phase 2 analysis provides a clinical efficacy signal for ENV-105 in metastatic prostate cancer resistant to standard hormone therapy. ENV-105 is an investigational first-in-class antibody targeting CD105, a protein that Kairos Pharma has identified as a driver of treatment resistance and disease relapse following standard cancer therapy. The company is evaluating whether targeting CD105 can help overcome mechanisms that allow cancer cells to resist established treatments. In the current study, ENV-105 is being evaluated in combination with apalutamide, a standard androgen-signaling inhibitor, with the objective of improving disease control. The reported difference in median PFS between the treatment groups forms the key clinical finding from the interim analysis and provides the principal basis for the company’s decision to modify the Phase 2 development strategy. Kairos Pharma said the results further support its broader approach of addressing drug resistance in oncology through targeted therapeutic strategies.

Kairos Pharma Modifies Phase 2 Trial Enrollment Strategy

Following the interim efficacy signal, Kairos Pharma has modified the Phase 2 protocol to evaluate patients earlier in the course of disease progression. Under the modified protocol, rather than requiring patients to receive treatment after one or two anti-androgen agents, the study will enroll patients who experience a PSA increase following upfront treatment with an androgen signaling inhibitor. Patients will be randomized to receive enzalutamide alone or enzalutamide in combination with ENV-105. According to the company, the protocol modification is intended to broaden the eligible patient population and facilitate trial enrollment while continuing to investigate the potential clinical benefit of ENV-105. The Phase 2 study has enrolled patients at Cedars-Sinai Medical Center, City of Hope and Huntsman Cancer Institute at the University of Utah. Kairos Pharma is targeting completion of the Phase 2 trial in or before the fourth quarter of 2027.

Kairos Pharma Advances Drug-Resistance Oncology Strategy

The Phase 2 update strengthens Kairos Pharma’s clinical development strategy focused on overcoming cancer drug resistance and immune suppression. The company is developing ENV-105 as a targeted approach against CD105, with the broader goal of restoring or improving the activity of standard cancer therapies in resistant disease. The current clinical program is centered on metastatic prostate cancer, while the company’s stated development strategy seeks to explore the potential of CD105 targeting across multiple cancer types. The interim PFS findings provide an important clinical data point for the ENV-105 program, while the modified protocol will test the therapy in an earlier disease setting and use a revised treatment combination involving enzalutamide. As Kairos Pharma continues the Phase 2 study, the company expects the modified enrollment strategy to support continued clinical evaluation and target trial completion by late 2027. The interim results and protocol modification represent key development milestones for ENV-105 as Kairos Pharma advances its drug-resistance-focused oncology pipeline.

Source:: Kairos Pharma, press release