#South Korea #Seoul #J INTS BIO #JIN-A02 #EGFR-TKI

J INTS BIO Presents Global Clinical Results of JIN-A02

The American Society of Clinical Oncology 2025 (ASCO 2025) has been the stage where J INTS BIO, a notable player in the field of therapeutics for cancer and rare diseases, announced interim findings from its ongoing global clinical trial of JIN-A02. As the largest oncology conference globally, ASCO provided an ideal platform for J INTS BIO to share exciting data regarding their fourth-generation EGFR-TKI, designed specifically for overcoming resistance mutations that occur after traditional treatments fail.

Overview of JIN-A02

JIN-A02 is administered orally and particularly targets patients whose cancers have developed resistance, such as the C797S mutation. This drug is critical in treating patients with EGFR-mutant Non-small cell lung cancer (NSCLC) — a condition often challenging to handle with conventional therapies. The clinical trials are currently taking place in several countries, including South Korea, the US, and Thailand, emphasizing its global significance.

Key Findings from the Clinical Trial

In the presentation at ASCO, crucial outcomes from Part A of the multi-center clinical trial (NCT05394831) were disclosed. Among these, one of the most striking findings was the sustained anti-tumor responses observed across different dosage groups, including 50mg, 100mg, and 300mg. Notably, in the 50mg dosage category, patients experienced a staggering 77.3% reduction in tumor size, maintaining this without a hitch for six consecutive treatment cycles. Similarly, the 300mg group exhibited a verified partial tumor size reduction of 39.7%, along with meaningful improvements in brain metastases.

Furthermore, the data reported indicated that patients in the 100mg group saw a 35.3% reduction in tumor size, with stable brain metastatic lesions, underscoring JIN-A02’s potential in addressing brain metastases effectively.

Safety and Tolerability Profile

Safety metrics also emerged positively, revealing no dose-limiting toxicities (DLTs) or severe adverse events at doses as high as 300mg — notably six times higher than when a partial response was first recorded. The majority of reported adverse events were mild (Grade 1-2) and included common reactions such as skin rash and diarrhea, typical for EGFR inhibitors but manageable. Encouragingly, no severe systemic toxicities were reported, establishing a robust safety profile for JIN-A02.

The favorable safety outcomes have facilitated longer treatment periods in real-world settings, with reports of patients remaining on JIN-A02 for over a year and seven months. Importantly, the trial indicated notable responses in brain metastases from as early as the 100mg dose, suggesting effective penetration of the drug into brain tissues.

Continued Success for J INTS BIO

Recognition of JIN-A02 has transcended just clinical results. Recently, J INTS BIO was selected for South Korea's '2025 Baby Unicorn Fostering Project,' which aims at supporting promising startups with innovative technology and significant growth potential. This government initiative will provide both financial support for JIN-A02's Phase 2 trial and broader global expansion, highlighting the drug's potential in the oncology landscape.

Dr. Anna Jo, CEO of J INTS BIO, expressed hopefulness saying, "The ASCO presentation underscored our capability to trigger anti-cancer responses and address central nervous system metastatic lesions, showcasing our drug's significance in treating complicated cases. Additionally, the sustained governmental support validates our innovative abilities and growth potential. We aim to capitalize on this momentum for a quicker global clinical reach and commercialization."

J INTS BIO plans to kick off the Phase 2 clinical trials for JIN-A02 before year’s end, alongside ongoing discussions with the US FDA, marking an exciting progression in their endeavors to bring this promising therapeutic option to market.