LOS ANGELES, July 15, 2026
Kairos Pharma announced encouraging interim safety results from its ongoing Phase 1 clinical trial evaluating ENV-105 (carotuximab) in combination with osimertinib (Tagrisso®) for patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC). Across the first 13 treated patients, the investigational combination demonstrated a favorable safety profile with no Grade 3 or higher toxicities attributed to ENV-105, supporting continued clinical development and progression toward an early efficacy assessment.
ENV-105 Aims to Reverse Resistance to EGFR Therapy
ENV-105 is a first-in-class CD105-targeting antibody designed to overcome acquired resistance to osimertinib, the current global standard-of-care for EGFR-mutated NSCLC. CD105 (endoglin) has been identified as a key driver of resistance pathways that emerge following prolonged EGFR-targeted therapy. By blocking CD105 signaling, ENV-105 is intended to restore tumor sensitivity to osimertinib, potentially extending progression-free survival and addressing a significant unmet need for patients whose disease progresses after first-line treatment.
Interim Phase 1 Data Support Continued Clinical Development
The ongoing Phase 1 study is evaluating the safety, tolerability, and recommended Phase 2 dose of the ENV-105 and osimertinib combination. Interim results showed that all treatment-related adverse events were manageable with standard supportive care, while no dose-limiting Grade 3 or higher toxicities were observed among the initial patient cohort. These findings support continued enrollment and future efficacy evaluation of the combination therapy.
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Broader Potential Across Drug-Resistant Cancers
Kairos Pharma is developing ENV-105 as a platform therapy targeting drug resistance across multiple cancer types. In addition to the ongoing NSCLC study, the antibody is being evaluated in a Phase 2 clinical trial for castration-resistant prostate cancer, where previous clinical findings demonstrated encouraging progression-free survival. The company believes targeting CD105 may provide a differentiated strategy to restore responsiveness to established cancer therapies, potentially expanding treatment options for patients with resistant malignancies while extending the clinical utility of existing targeted therapies such as Tagrisso.
Source: Kairos Pharma press release
