On February 26, 2024 J INTS BIO reported that the Phase 1/2 clinical study of its Novel Oral 4th Generation EGFR TKI "JIN-A02" for the treatment of NSCLC has been accepted for poster presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) meeting to be held in San Diego USA from 5 to 10 April (Press release, J INTS BIO, FEB 26, 2024, View Source [SID1234640472]).
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The American Association for Cancer Research (AACR) (Free AACR Whitepaper) is an authoritative cancer society and is considered one of the world’s top three societies in the field of cancer, along with the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper). J INTS BIO will present a poster during the "Phase I Clinical Trials in Progress" session, which will be held on April 8 from 1:30 to 5:00 p.m.
The topic of the presentation is "Phase 1/2 clinical trial of JIN-A02, a 4th generation EGFR-TKI for 3rd generation EGFR-TKI resistant patients in EGFR mutated advanced/metastatic non-small cell lung cancer".
‘JIN-A02’, a 4th generation EGFR-TKI, selectively binds to C797S, a mutation that leads to resistance to the use of 3rd generation EGFR-TKIs (such as Osimertinib, Lazertinib), in the treatment of EGFR+ NSCLC. ‘JIN-A02’ is highly selective for and strongly inhibits NSCLC with C797S double or triple mutations and is expected to show efficacy against intracranial tumors due to its high blood-brain barrier permeability.
In August last year, J INTS BIO registered the first patient for the global Phase 1/2 clinical trial of ‘JIN-A02’ at Severance Hospital in Korea. This clinical study is currently recruiting patients with EGFR mutation-positive and advanced NSCLC at in Korea, including Asan Medical Center and the National Cancer Center, and the University of California (U.C. Irvine).
The dose escalation part of the study is now at its 4th dose level, and despite the preceding low dose levels, early efficacy responses were observed in targeted lesions, especially in patients with the C797S mutation. J INTS BIO plans to expand the number of clinical trial sites globally and in Korea, this will include Seoul National University Hospital, Samsung Seoul Hospital, and Seoul St. Mary’s Hospital.
A J INTS BIO official said, "The global clinical trial for ‘JIN-A02’ is progressing well and is receiving interest in the global market."
Details of the AACR (Free AACR Whitepaper) presentation will be released on April 8th.