JIN-A02 Demonstrates Tumor Reduction in Phase 1 Study, Including Brain Metastasis

In an important update, J INTS BIO announced progress in its Phase 1 clinical trial of JIN-A02, a 4th generation EGFR-TKI developed for the treatment of non-small cell lung cancer (NSCLC). The latest findings were shared during the June 3 poster session at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago from May 31 to June 4.

Recent data revealed a new instance of tumor Partial Response (PR) in a patient from Cohort 4, who was administered a daily dose of 100mg. Previously, the first PR was observed in a patient from an earlier cohort with a daily dose of 50mg. Notably, the first evidence of brain tumor activity also emerged in this cohort, showing a 28.6% reduction in brain metastasis.

To date, two patients have exhibited partial responses, while three others have maintained stable disease. The patient with reduced brain metastasis is among the stable cases, alongside two individuals from earlier cohorts who received lower doses. The final patient in the 100mg dose group is completing their dose-limiting toxicity (DLT) assessment, with no DLT detected so far. Additionally, common side effects associated with EGFR TKIs, such as rash, diarrhea, or cardiac toxicity, have not been reported, despite the positive clinical outcomes. The next stage of the study, involving a daily dose of 150mg, is set to commence at the end of June.

A representative from J INTS BIO remarked on the significance of presenting crucial clinical results at a major global conference attended by leading cancer experts and research professionals. They expressed optimism that JIN-A02 could revolutionize the treatment landscape for patients with EGFR C797S positive NSCLC, currently lacking approved therapies. The company plans to initiate Phase 2 clinical trials by the end of the year.

J INTS BIO is a biotechnology company dedicated to developing innovative anti-cancer and orphan drugs, aiming to enhance and extend the lives of patients worldwide. Staffed by experienced professionals with backgrounds in multinational pharmaceutical firms and clinical research organizations, J INTS BIO excels in fields such as medical, regulatory affairs, and drug discovery and development.

JIN-A02 stands out as an advanced orally administered 4th generation EGFR TKI, targeting C797S mutations in NSCLC. While earlier generations of EGFR TKIs have shown varying levels of success, recurrence remains a common issue, even with 3rd generation treatments like Osimertinib. Currently, no approved treatments exist for patients who develop C797S mutations following 3rd generation EGFR TKI use. Given the high likelihood of these cancers to spread to the brain, there is an urgent need for a drug with high blood-brain barrier permeability.

JIN-A02 promises to address this critical gap. As an effective oral EGFR TKI against C797S mutations with high brain penetrance, it has the potential to become the leading 4th generation EGFR TKI for NSCLC patients who currently have limited or no viable treatment options. The ongoing development and promising results of JIN-A02 mark a significant step forward in the quest for more effective NSCLC treatments.