Kairos Pharma has shared interim safety data from its ongoing Phase I clinical trial evaluating ENV-105 (carotuximab) in combination with osimertinib (AstraZeneca’s Tagrisso) in patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC).

The company says the data represent a pivotal milestone in its lead programme: resensitising patients who have acquired resistance to osimertinib.  

With no serious adverse events observed across 13 treated patients to date from ENV-105 treatment, the safety profile supports continued progression toward an early efficacy readout. 

Non-small cell lung cancer accounts for approximately 85% of all lung cancer diagnoses globally. The EGFR-NSCLC market alone is valued at approximately $10 billion across leading current markets, growing at a CAGR of 10.5%, projected to be over $13 billion by 2030. 

Osimertinib is the gold-standard, first-line therapy for this patient population with about $6 billion in sales annually. However, once a patient progresses on osimertinib, therapeutic options are limited. 

CD105 (endoglin) is pathologically elevated in patients who develop osimertinib resistance, and its overexpression drives one of the core resistance signalling pathways. ENV-105 (carotuximab) is a first-in-class CD105 antibody that blocks the signalling of this overexpressed protein, mechanistically dismantling the resistance phenotype and creating the biological conditions for osimertinib sensitivity.  

This strategy supports extending progression-free survival, preserving quality of life, and fundamentally increasing the clinical utility of the world’s most prescribed EGFR-targeted therapy. If successful, ENV-105 would not compete with osimertinib – it would extend its commercial life across the entire EGFR-mutated patient population. 

“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 of Kairos Pharma.