Pharma Focus Asia

J INTS BIO, ASCO 2024 - JIN-A02 showed tumor reductions including brain metastasis in the ongoing first-in-human, dose-finding Phase 1 clinical study

Monday, June 10, 2024

J INTS BIO provided an update of its ongoing Phase 1 clinical study of JIN-A02, a 4th generation EGFR-TKI for NSCLC treatment, during the 3rd of June poster session of the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting held at McCormick Place in Chicago, USA, from May 31 to June 4.

This latest study update of JIN-A02 reported another tumor Partial Response (PR) in a patient in Cohort 4 (100mg daily). The first tumor Partial Response (PR) recorded in this study, was a patient in the earlier Cohort at a lower dose of 50mg daily. In addition, the first instance of brain tumor activity was recorded in Cohort 4, with a 28.6% reduction of the brain metastasis.

To-date, Partial Response (PR) has been confirmed in two patients and Stable Diseases in three other, including the patient with reduction of brain metastasis in Cohort 4 and two patients from the lower Cohorts at a lower dose.

The final patient in Cohort 4 (100mg) is expected to complete the dose-limiting toxicity (DLT) assessment period soon and thus far, no DLT has been detected. In addition, no rash, diarrhea, or cardiac toxicity (side effects commonly associated with EGFR TKIs use), has been reported in this study despite the positive efficacy signals and clinical benefits already observed. The next Cohort at 150mg daily will begin end of June.

J INTS BIO said, "It is very meaningful to be able to share key clinical results in large-scale global conferences attended by global anticancer experts and research and development officials." and "JIN-A02 is expected to be a game changer to improve the life of patients with EGFR C797S positive NSCLC, for which there is currently no approved treatment," they added. According to the company, JIN-A02 is scheduled to enter phase 2 clinical trial by the end of this year.


J INTS BIO is a bio company specialized in developing innovative anti-cancer and orphan drugs to realize the goal of changing lives and improving health for patients around the world. J INTS BIO's teams have prior multi-year experience in multinational pharmaceutical companies and CROs and track records in medical, regulatory affairs, drug discovery and development.

About 'JIN-A02'

'JIN-A02' is a novel orally administered 4th Generation EGFR TKI targeting C797S mutations in NSCLC. Although 1st, 2nd, and 3rd Generation EGFR TKIs have been used with some success, recurrence occurs in most patients including 3rd Generation TKIs such as Osimertinib. Currently, there are no approved therapies for patients who developed EGFR C797S mutations due to the use of 3rd Generation EGFR TKIs and with the high propensity of these cancers to metastasize to the brain, there is an urgent need to develop an effective drug with high blood-brain barrier permeability. 'JIN-A02', a novel oral EGFR TKI, which is effective against C797S mutations and have a high brain penetrance, is therefore expected to become the most promising Best-in-Class 4th-generation EGFR TKI in NSCLC patients with limited or no viable treatment options.



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