Kairos reports positive interim Phase 1 safety data for ENV-105 in EGFR-mutated lung cancer
Kairos Pharma has reported positive interim safety results from an ongoing Phase 1 trial evaluating ENV-105 in combination with osimertinib for patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC).
The early-stage study is investigating whether ENV-105 (carotuximab), an antibody targeting CD105, can be safely combined with AstraZeneca’s EGFR inhibitor osimertinib in patients whose disease has developed resistance to treatment.
According to the company, 13 patients have received the combination therapy to date, with no Grade 3 or higher toxicities attributed to ENV-105.
The Phase 1 study is designed to evaluate safety, tolerability and determine the recommended Phase 2 dose, with adverse events assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Kairos said all reported side effects were manageable with standard supportive care.
Patients with EGFR-mutated NSCLC often respond well initially to osimertinib, but many eventually develop resistance, limiting future treatment options. Kairos is investigating whether inhibiting CD105 could help restore tumour sensitivity to EGFR-targeted therapy.
John Yu, chief executive officer of Kairos Pharma, said: “Our goal is not simply to complete a Phase 1 trial; it is to deliver a re-sensitization 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.”
The company said CD105 has been identified as a potential driver of treatment resistance in several cancer types, including EGFR-mutated NSCLC, providing the scientific rationale for evaluating ENV-105 in combination with existing targeted therapies.
Kairos also noted that ENV-105 is being investigated in a separate Phase 2 study in castration-resistant prostate cancer.
The company said the Phase 1 lung cancer study will continue to assess safety while generating data to support future efficacy evaluation and dose selection.
