J INTS BIO announced promising interim results from its global Phase 1/2 clinical trial of JIN-A02, a fourth-generation EGFR tyrosine kinase inhibitor (TKI), at the American Society of Clinical Oncology 2025 (ASCO 2025) conference in Chicago. The oral drug candidate is specifically designed to overcome resistance mutations, such as C797S, that develop after treatment failure with third-generation EGFR-TKIs, which currently serve as first-line therapy for EGFR-mutant non-small cell lung cancer (NSCLC).
Clinical Efficacy Demonstrates Sustained Tumor Responses
The multi-center clinical trial (NCT05394831) Part A dose escalation study revealed confirmed partial responses (PRs) across multiple dose cohorts, verified by independent evaluation. In the 50mg dose group, patients achieved a remarkable 77.3% reduction in tumor size, maintaining a partial response over six consecutive treatment cycles from cycle 3 to cycle 13.
The 300mg dose group demonstrated a confirmed partial response with a 39.7% tumor size reduction, including significant reduction in brain metastatic lesions. Similarly, the 100mg dose group reported a partial response with a 35.3% reduction in tumor size, while brain metastatic lesions remained stable, further supporting JIN-A02's potential in treating brain metastases.
Safety Profile Supports Higher Dose Administration
No dose-limiting toxicities (DLTs) or serious adverse events were observed with JIN-A02 at doses up to 300mg, which represents six times the dose level when partial response was first observed. The majority of adverse events reported at 300mg were mild (Grade 1-2) and included Grade 1 skin rash, diarrhea, and skin desquamation in 3 out of 5 subjects – events commonly associated with EGFR inhibitors and generally considered clinically manageable.
Importantly, no systemic toxicities such as cardiovascular events or hepatotoxicity were reported, supporting the drug's excellent safety profile. This favorable tolerability has translated into extended treatment durations, with one patient remaining on JIN-A02 treatment after one year and seven months.
Brain Metastases Show Therapeutic Response
The trial demonstrated notable responses in brain metastases first observed at the 100mg dose level, suggesting that JIN-A02 achieves therapeutically relevant concentrations in brain tissue. This finding is particularly significant given the challenge of treating central nervous system metastases in NSCLC patients.
Government Recognition Accelerates Development Timeline
J INTS BIO was recently selected for the 2025 Baby Unicorn Fostering Project by the Ministry of SMEs and Startups, officially recognizing both the company's scientific technology and commercialization potential. The Baby Unicorn Fostering Project focuses on developing promising startups with innovative technologies and growth potential in the global market as potential unicorns.
This recognition will provide dual funding for JIN-A02's Phase 2 trial and global expansion over the next two years, expected to significantly accelerate clinical and commercialization efforts alongside private investment. The company plans to initiate Phase 2 clinical trials before the end of this year, following discussions with the US FDA.
"The ASCO presentation of JIN-A02's ability to induce anti-cancer responses and its ability to respond to central nervous system metastatic lesions is of great significance," said Dr. Anna Jo, CEO. "The government's continued support is a recognition of our technical capabilities and potential for growth. We will take advantage of this opportunity to accelerate global clinical expansion, technology transfer, and indication expansion to realize our goal of early commercialization."
JIN-A02 is currently undergoing clinical trials in South Korea, the United States, Thailand, and other countries, positioning the company for potential global market entry upon successful completion of clinical development.
