SEOUL, South Korea, Dec. 5, 2023 /PRNewswire/ — J INTS BIO announced that early results of the Phase 1/2 study of its novel, orally administered 4th generation EGFR-TKI ‘JIN-A02’ were presented at the ESMO Asia 2023 conference held in Singapore from 1st to 3rd December 2023.
‘JIN-A02’, a 4th generation EGFR-TKI, is a substance that selectively binds to C797S, a mutation that leads to resistance to 3rd generation EGFR-TKIs (Osimertinib, Lazertinib), a treatment for EGFR+ NSCLC. It has demonstrated strong efficacy in preclinical studies, and the results have already been presented at several academic conferences.
Currently, the company is conducting a global phase 1/2 clinical study to evaluate the safety, pharmacokinetics, and anti-tumor activity of “JIN-A02” in patients with advanced NSCLC carrying EGFR mutations.
During ESMO Asia, the safety and PK results for the first two cohorts of patients recruited in Part A (Dose Escalation) of the clinical study were presented. To-date, no dose limiting toxicities (DLTs) or maximum tolerated dose (MTD) were reported and dosing for the 3rd cohort of patients will begin very soon.
According to J INTS BIO, the clinical study is progressing well and recruitment has been unexpectedly successful with no unnecessary delays between the cohorts. The company also noted that further dose escalations will allow a robust evaluation of the anti-tumor effects of ‘JIN-A02’, and enable the assessment of its overall safety.