Kairos Pharma has reported encouraging interim safety results from its ongoing Phase I clinical trialevaluating ENV-105 (carotuximab) in combination with AstraZeneca's Tagrisso (osimertinib) for patients with advanced epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).

The study is assessing the safety, tolerability and recommended Phase II dose of ENV-105 when administered alongside osimertinib, the current global standard of care for EGFR-mutated NSCLC.

According to the company, none of the 13 patients enrolled in the trial have experienced Grade 3 or higher treatment-related adverse events associated with ENV-105. Reported side effects have been manageable using standard supportive care measures.

The combination therapy is being investigated in patients whose disease has developed resistance to osimertinib, a major clinical challenge in the treatment of EGFR-mutated NSCLC. Adverse events are being evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) 5.0, with dose-limiting toxicities monitored during the initial treatment cycles.

"Our goal is not simply to complete a Phase I trial; it is to deliver a re-sensitisation solution that changes the post-progression treatment paradigm and positions Kairos as the essential complement to the EGFR-targeted therapy market with this clean safety profile now confirmed across 13 patients," said Dr. John Yu, Chief Executive Officer, Kairos Pharma.

ENV-105 is a monoclonal antibody targeting cluster of differentiation 105 (CD105), a protein believed to be elevated in patients who develop resistance to osimertinib. By targeting this pathway, the therapy aims to restore tumour sensitivity to EGFR-targeted treatment and potentially extend its clinical benefit.

Kairos noted that osimertinib, marketed as Tagrisso, generates annual global sales of approximately $6 billion, highlighting the significant market opportunity for therapies that can overcome resistance to the drug.

Beyond lung cancer, ENV-105 is also being evaluated in an ongoing Phase II trial for castration-resistant prostate cancer, where it is being studied for its potential to improve median progression-free survival.

"ENV-105 continues to be extremely well tolerated, now across two very different indications. As we continue to showcase ENV-105's potential for targeting drug resistance, this data is another important milestone in achieving our goal to ultimately provide better patient care over a longer term," said Dr. Neil Bhowmick, Chief Science Officer, Kairos Pharma.