Kairos Pharma Reports Positive Interim Safety Results from Phase 1 Trial of ENV-105 in EGFR-Mutated Lung Cancer
Thursday, July 16, 2026
Kairos Pharma has reported positive interim safety results from its ongoing Phase 1 clinical trial of ENV-105 (carotuximab) in combination with osimertinib (Tagrisso) for patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC).
The trial is evaluating ENV-105 as a treatment to restore the effectiveness of osimertinib in patients who have developed resistance to the therapy. Interim results from 13 treated patients showed no serious treatment-related adverse events of Grade 3 or higher linked to ENV-105, supporting the programme's continued development towards an early assessment of efficacy.
Non-small cell lung cancer accounts for around 85% of all lung cancer cases worldwide. Patients with EGFR mutations represent a major treatment group, with the global EGFR-mutated NSCLC market valued at approximately US$10 billion and expected to exceed US$13 billion by 2030. Osimertinib is the standard first-line treatment for these patients, generating annual sales of around US$6 billion. However, patients eventually develop resistance to the drug, and there are currently no approved treatments specifically designed to reverse this resistance.
Kairos Pharma is developing ENV-105 to address this unmet need. The therapy targets CD105 (endoglin), a protein that is found at increased levels in patients who develop resistance to osimertinib. By blocking CD105 signalling, ENV-105 is designed to restore tumour sensitivity to osimertinib, with the aim of extending progression-free survival, maintaining quality of life, and improving the long-term effectiveness of the treatment.
The company stated that the favourable safety profile observed in the Phase 1 trial supports further clinical development of ENV-105 as a complementary therapy for EGFR-mutated NSCLC rather than a replacement for osimertinib.
The scientific basis for targeting CD105 has been supported by previous research showing its role in treatment resistance and disease recurrence across several types of cancer. Preclinical studies have also demonstrated that ENV-105 can improve tumour sensitivity to radiation and hormone therapies.
In addition to the lung cancer programme, ENV-105 is being evaluated in an ongoing Phase 2 trial for castration-resistant prostate cancer. According to the company, the study has shown a median progression-free survival of more than 13 months, suggesting that suppressing CD105 may provide lasting clinical benefits across different tumour types and treatment-resistant cancers.
Kairos Pharma believes the latest safety findings further support the continued clinical development of ENV-105 as a potential treatment for overcoming drug resistance in cancer.
Source: businesswire.com
