J INTS BIO 4th Generation EGFR TKI (JIN-A02) US FDA Phase 1/2 IND submission completed

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Jun 03, 2022, 04:00 ET

SEOUL, South Korea, June 3, 2022 /PRNewswire/ -- J INTS BIO, a company specializing in the development of novel anticancer and orphan drugs, announced on the 3rd of June that it had completed the Phase 1/2 IND submission of 'JIN-A02', a novel 4th Generation EGFR-TKI for NSCLC treatment, to US FDA.

'JIN-A02' is a novel orally administered 4th generation EGFR TKI that targets NSCLC cancers harboring C797S mutation. C797S is a mutation that occur after the use of 3rd generation EGFR TKIs such as Osimertinib and Lazertinib, resulting in tumor resistance and disease relapse.

According to J INTS BIO, 'JIN-A02' not only showed robust inhibitory activities against NSCLC cancers with triple mutations (Ex19Del or L858R/T790M/C797S) involving EGFR C797S mutations, but also on double mutations (Ex19Del/C797S or L858R/C797S) with C797S, Ex19Del/T790M and L858R/T790M mutations in in vitro studies. In addition, 'JIN-A02' also effectively reduced tumor volume in a dose-dependent manner, compared to Osimertinib, in mouse model harboring EGFR Ex19Del/T790M/C797S triple mutation cancers and exhibited high brain penetrance with efficacy against intracranial tumor.

A company official added that 'JIN-A02' demonstrated a favorable safety profile with a low propensity for cardiotoxicity and did not show significant toxic effects such as weight loss and cytotoxicity in animal models at therapeutic dose levels. It is therefore expected to become a highly valued new drug in the armamentarium for the treatment of NSCLC.

Meanwhile, J INTS BIO announced that it plans to conduct a global clinical study with sequential IND submissions in Korea, China, Hong Kong, Singapore, Taiwan, and Australia, following the US FDA IND submission.

SOURCE J INTS BIO