Kairos Pharma has reported interim safety results from its ongoing Phase I clinical trial of ENV-105 (carotuximab), along with AstraZeneca’s Tagrisso (osimertinib), in patients with advanced epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).
The trial is designed to evaluate the safety, tolerability and recommended Phase II dose of ENV-105 when administered alongside osimertinib.
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So far, none of the 13 patients treated in the trial have experienced serious adverse events (Grade 3 or higher) linked to ENV-105.
The combination therapy is being assessed in patients who have developed resistance to osimertinib, which is the current global standard-of-care drug for EGFR-mutated NSCLC.
Adverse events are being assessed according to the common terminology criteria for adverse events (CTCAE) 5.0, and dose-limiting toxicities are monitored during the initial treatment cycles.
Side effects reported so far were manageable with the use of standard supportive care measures.
Kairos Pharma CEO Dr John Yu said: “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.”
Kairos Pharma stated that osimertinib is widely used for EGFR-mutated NSCLC, with annual sales of around $6bn.
ENV-105 is an antibody targeting cluster of differentiation 105 (CD105), a protein reported to be elevated in patients who develop resistance to osimertinib.
In a separate ongoing Phase II trial for castrate-resistant prostate cancer, it is being examined for its effect on median progression-free survival.
Kairos Pharma chief science officer Dr Neil Bhowmick said: “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.”
