NEW YORK – J Ints Bio said on Friday that it will begin enrolling non-small cell lung cancer patients in the US into a Phase I/II trial evaluating its EGFR inhibitor JIN-A02.
The US Food and Drug Administration cleared the firm's investigational new drug application, allowing J Ints Bio to begin evaluating JIN-A02 as a treatment for NSCLC patients harboring EGFR C797S mutations, a biomarker associated with resistance to earlier-generation EGFR inhibitors including AstraZeneca's third-generation EGFR TKI Tagrisso (osimertinib).
Through in vivo studies, J Ints Bio's investigational drug has demonstrated selective activity against C797S double or triple mutations presenting in either cis or trans form. The drug has also shown it can penetrate the blood-brain barrier.
Seoul, South Korea-based J Ints Bio said it is seeking IND clearance to begin evaluating the drug in clinical trials outside the US as well.