J INTS BIO, a bio company based in Seoul, South Korea, has initiated a Phase 1/2 clinical study for its novel EGFR TKI drug, called JIN-A02, designed to treat non-small cell lung cancer (NSCLC) patients. The company announced the successful dosing of the first patient in the study, which is being conducted at Severance Hospital in Seoul. This global multi-center trial aims to assess the safety, pharmacokinetics, and anti-tumor activity of JIN-A02 in advanced NSCLC patients with EGFR mutations, which are common in this type of cancer.
JIN-A02 is a 4th Generation EGFR TKI that is administered orally. It is highly selective and offers strong inhibition of NSCLC with specific double or triple EGFR mutations, including the C797S mutation. The drug has shown efficacy against intracranial tumors, as it can effectively cross the blood-brain barrier. Unlike previous generations of EGFR TKIs, JIN-A02 offers potential treatment options for patients who have developed the EGFR C797S mutation after using 3rd Generation TKIs such as Osimertinib. Currently, there are no approved therapies available for these patients.
CEO of J INTS BIO, Anna Jo, expressed optimism about the clinical trial, stating that positive results from pre-clinical studies have led to high expectations for patient outcomes during the trial. The company also hopes to apply for the designation of an orphan drug, which would expedite the process of bringing JIN-A02 to market for NSCLC therapy.
In addition to Severance Hospital, the study will be conducted at seven other hospitals in Korea, including the National Cancer Center, Chungbuk National University Hospital, Samsung Seoul Hospital, Seoul National University Hospital, Seoul St. Mary’s Hospital, St. Vincent Hospital, and Asan Medical Center. Two sites in the United States and one in Thailand will also participate in the trial.
J INTS BIO specializes in developing innovative anti-cancer and orphan drugs. The company’s teams have extensive experience in multinational pharmaceutical companies and contract research organizations (CROs), with a strong track record in medical, regulatory affairs, and drug discovery and development.
The initiation of the clinical trial for JIN-A02 brings hope for NSCLC patients with EGFR mutations, who currently have limited treatment options. With its potential to target specific mutations and cross the blood-brain barrier, JIN-A02 holds promise as a Best-in-Class 4th-generation EGFR TKI. The study will provide valuable data on the drug’s safety, efficacy, and pharmacokinetics, paving the way for its potential approval and widespread use in the future.
