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Significant anti ~ J INTS BIO, a leading biopharmaceutical company focused on developing therapeutics for cancer and rare diseases, made a major announcement at the American Society of Clinical Oncology 2025 (ASCO 2025) conference in Chicago, USA. The company officially presented interim results from its global Phase 1/2 clinical trial of JIN-A02, its fourth-generation EGFR-TKI drug candidate.
The presentation was made by Professor Byoung Chul Cho from Yonsei Cancer Center, who posed with the JIN-A02 poster at the conference. JIN-A02 is an oral medication designed to overcome resistance mutations that develop after treatment failure with third-generation EGFR-TKIs. These mutations are common in patients with EGFR-mutant Non-small cell lung cancer (NSCLC), which is currently treated with third-generation EGFR-TKIs as first-line therapy.
The drug is currently being tested in clinical trials in South Korea, the United States, Thailand, and other countries. The company presented key efficacy and safety results from Part A of the multi-center clinical trial (NCT05394831).
One of the most significant findings from the ASCO presentation was that tumor responses were sustained in specific dose cohorts. Confirmed partial responses (PRs) were observed in patients who received doses of 50mg, 100mg, and 300mg once daily. These PRs were verified by independent evaluation and provide strong evidence of anti-tumor activity.
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In the 50 mg dose group, patients experienced a 77.3% reduction in tumor size and maintained a PR over six consecutive treatment cycles. In the 300 mg dose group, a confirmed PR was observed with a 39.7% reduction in tumor size, including a significant reduction in brain metastatic lesions. In the 100 mg dose group, a PR was also reported with a 35.3% reduction in tumor size, and brain metastatic lesions remained stable. These results support the potential of JIN-A02 in treating brain metastases.
The drug also demonstrated a favorable safety profile, with no dose-limiting toxicities or serious adverse events observed at doses up to 300mg. This is six times the dose level when the first PR was observed, indicating that the drug is well-tolerated even at higher doses. The majority of adverse events reported at 300mg were mild and manageable. Importantly, there were no reports of systemic toxicities such as cardiovascular events or hepatotoxicity.
The trial also showed promising responses in brain metastases, which were first noted at a dose of 100mg. This suggests that JIN-A02 can achieve therapeutically relevant concentrations in brain tissue.
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In addition to the ASCO presentation, J INTS BIO has recently achieved significant recognition in Korea. The company was selected for the '2025 Baby Unicorn Fostering Project' by the Ministry of SMEs and Startups, which recognizes innovative startups with potential for global growth. As part of this project, JIN-A02 will receive dual funding for its Phase 2 trial and global expansion over the next two years.
Dr. Anna Jo, CEO of J INTS BIO, expressed her excitement about these achievements and their plans for the future. "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," she said. "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."
Based on these achievements, the company plans to initiate a Phase 2 clinical trial before the end of this year in discussions with the US FDA. With the support of the government and private investment, J INTS BIO is well-positioned to continue its mission of developing innovative therapeutics for cancer and rare diseases.
The presentation was made by Professor Byoung Chul Cho from Yonsei Cancer Center, who posed with the JIN-A02 poster at the conference. JIN-A02 is an oral medication designed to overcome resistance mutations that develop after treatment failure with third-generation EGFR-TKIs. These mutations are common in patients with EGFR-mutant Non-small cell lung cancer (NSCLC), which is currently treated with third-generation EGFR-TKIs as first-line therapy.
The drug is currently being tested in clinical trials in South Korea, the United States, Thailand, and other countries. The company presented key efficacy and safety results from Part A of the multi-center clinical trial (NCT05394831).
One of the most significant findings from the ASCO presentation was that tumor responses were sustained in specific dose cohorts. Confirmed partial responses (PRs) were observed in patients who received doses of 50mg, 100mg, and 300mg once daily. These PRs were verified by independent evaluation and provide strong evidence of anti-tumor activity.
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In the 50 mg dose group, patients experienced a 77.3% reduction in tumor size and maintained a PR over six consecutive treatment cycles. In the 300 mg dose group, a confirmed PR was observed with a 39.7% reduction in tumor size, including a significant reduction in brain metastatic lesions. In the 100 mg dose group, a PR was also reported with a 35.3% reduction in tumor size, and brain metastatic lesions remained stable. These results support the potential of JIN-A02 in treating brain metastases.
The drug also demonstrated a favorable safety profile, with no dose-limiting toxicities or serious adverse events observed at doses up to 300mg. This is six times the dose level when the first PR was observed, indicating that the drug is well-tolerated even at higher doses. The majority of adverse events reported at 300mg were mild and manageable. Importantly, there were no reports of systemic toxicities such as cardiovascular events or hepatotoxicity.
The trial also showed promising responses in brain metastases, which were first noted at a dose of 100mg. This suggests that JIN-A02 can achieve therapeutically relevant concentrations in brain tissue.
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In addition to the ASCO presentation, J INTS BIO has recently achieved significant recognition in Korea. The company was selected for the '2025 Baby Unicorn Fostering Project' by the Ministry of SMEs and Startups, which recognizes innovative startups with potential for global growth. As part of this project, JIN-A02 will receive dual funding for its Phase 2 trial and global expansion over the next two years.
Dr. Anna Jo, CEO of J INTS BIO, expressed her excitement about these achievements and their plans for the future. "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," she said. "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."
Based on these achievements, the company plans to initiate a Phase 2 clinical trial before the end of this year in discussions with the US FDA. With the support of the government and private investment, J INTS BIO is well-positioned to continue its mission of developing innovative therapeutics for cancer and rare diseases.
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