ISU Abxis has published an interim report confirming the safety profile for ISU104, an immunotherapy candidate.
The report came after the company held a steering committee as it has finished recruiting patients for Part 1 of the drug’s phase 1 clinical trial.
ISU 104 is a targeted therapy that controls ErbB3, also known as a human epidermal growth factor receptor 3 (HER3), the third of the group of ErbB or epidermal growth factor (EGF) proteins in the body related to cancer development.
Based on the data on dose and carcinoma identified in Part 1, the company plans to confirm the safety and efficacy of various regimens in Part 2 of the trial.
Part 1 of the clinical phase 1, consisted of a dose-increasing cohort study to determine the maximum tolerated dose after confirming safety by increasing the dose of ISU104 from 1 mg/kg to 20 mg/kg on 15 patients.
Part 2, which begins in the second half of the year, will include about 40 patients. Based on the results of the study identified in Part 1, the company plans to conduct a dose-expansion cohort study to confirm the efficacy of ISU104's recommended phase 2 dose.
Isu Abxis is currently conducting clinical trials in five institutions -- Asan Medical Center, Seoul National University Hospital, Samsung Medical Center, Kosin University Gospel Hospital and Kyungpook National University Medical Center.
Participating in the trial are patients with end-stage advanced solid cancer who were resistant to standard therapy or who had no standard treatment. The company plans to evaluate the safety, efficacy, tolerability, and pharmacokinetics in phase 1 clinical trials.
Isu Abxis plans to complete the trial by 2020.