Salute e Benessere
J INTS BIO Presents Interim Findings from Phase 1/2 Clinical Trial of 4th-Generation EGFR-TKI 'JIN-A02' in NSCLC: A Potential Breakthrough in Overcoming Acquired Resistance to Targeted Therapy
Mutations in the epidermal growth factor receptor (EGFR) is a key driver in the pathogenesis of NSCLC, with 3 Generation EGFR-TKIs like osimertinib serving as the cornerstone of treatment. Unfortunately, eventually resistance to this treatment will occur, leading to cancer relapse and disease progression. JIN-A02, developed by J INTS BIO, is the 4th-generation EGFR-TKI specifically designed to address this. By targeting both the original mutations and those acquired subsequently as a result of cancer treatments, it offers a therapeutic solution for these patients.
The ongoing Phase 1/2 clinical trial evaluates JIN-A02 in patients with advanced or metastatic NSCLC who have developed resistance and disease progression after 3rd-generation EGFR-TKIs use. The study consist of 3 parts: dose escalation (Part A), dose exploration (Part B), and dose expansion (Part C). The data generated so far in Part A has been encouraging with a good safety profile and early efficacy signals, underscoring JIN-A02's position as a novel treatment for EGFR-TKI-resistant NSCLC.
J INTS BIO said, "New treatment are urgently needed for lung cancer patients whose disease has worsened or relapsed after treatment with 3rd-generation EGFR-TKI. JIN-A02 is potentially one such treatment option that can bring hope to patients world wide."
To date, the Part A of the study has enrolled 16 patients who received increasing doses of JIN-A02, starting with a low dose of 12.5mg daily to 150 mg daily, with the primary objective of determining the maximum tolerated dose (MTD). This Part also look at safety, pharmacokinetics, and anti-tumor activity as secondary objectives. Doses higher than 150mg are currently being studied in this Part.
Once we have the final doses to be used in Phase 2, the dose-expansion part of the study (Part B) will begin, and two doses will be selected and studied in bigger groups of patient to verify its safety, pharmacokinetics, and anti-tumor activity. Part B is essential for the selection of the final dose level to be used in Phase 2 or Part C of this study.
In this final part (Part C), we will investigate JIN-A02 in specific patient populations who are stratified by EGFR mutation subtypes and the presence of CNS metastases. Part C is critical for generating a bigger dataset on the drug's therapeutic potential across distinct NSCLC patient groups for regulatory approval purposes.
Professor Byeong Cheol Cho of Severance Hospital's Division of Medical Oncology, South Korea , commented on the significance of these findings, stating, "JIN-A02's demonstrated efficacy against both lung and its associated CNS disease underscores its potential as a groundbreaking treatment for patients with EGFR-TKI-resistant NSCLC, including and especially those with brain metastases."
JIN-A02's ability to effectively target CNS lesions represents a notable advancement and as a 4 generation EGFR-TKI, offers hope for patients with very limited options as a result of progression after 3rd-generation TKIs use.
J INTS BIO is fully committed to accelerating the clinical development of JIN-A02. And as the clinical study continues to enroll patients ahead of schedule, JIN-A02, is poised to shape the treatment landscape of NSCLC and to offer hope to lung cancer patients worldwide.