On July 31, 2023 J INTS BIO reported the successful dosing of the first patient in its global multi-center Phase 1/2 clinical study of ‘JIN-A02’ on 31st July at Severance Hospital, Seoul, Korea (Press release, J INTS BIO, JUL 31, 2023, View Source;dosing-of-first-patient-in-the-global-multi-center-phase-12-clinical-study-began-301888973.html [SID1234633559]).
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More clinical sites will follow suit, including seven more hospitals in Korea (National Cancer Center, Chungbuk National University Hospital, Samsung Seoul Hospital, Seoul National University Hospital, Seoul St. Mary’s Hospital, St. Vincent Hospital, Asan Medical Center), two in the United States, and one in Thailand.
This global phase 1/2 clinical trial seeks to evaluate the safety, pharmacokinetics and anti-tumor activity of "JIN-A02" in advanced NSCLC patients carrying EGFR mutations.
‘JIN-A02’ is a novel orally administered 4th Generation EGFR TKI, which is highly selective for and strongly inhibits NSCLC with C797S double or triple mutations, showing efficacy even against intracranial tumors by exhibiting high blood-brain barrier penetrance.
Anna Jo, CEO of J INTS BIO, said, "We expect the positive results of ‘JIN-A02’ in the pre-clinical studies to translate to positive outcomes for patients in the clinical trial" adding that, "We hope also to proceed with the application for designation of orphan drug, and thereby quickly occupy the global NSCLC therapy market through conditional use."