SillaJen Registers First Patient in South Korea for BAL0891 Phase 1 Clinical Trial

Shinilagen announced on the 31st that the first patient in Korea has been enrolled in the clinical trial of the mitotic checkpoint inhibitor (MCI) 'BAL0891'. The first patient in Korea was registered at Sinchon Severance Hospital. After completing the screening process, the first drug administration was completed.

BAL0891 is an anticancer drug licensed in from the Swiss pharmaceutical company Basilea and is undergoing clinical trials in the United States and Korea. The first patient was registered in the United States in February. In Korea, clinical trial approval was obtained from the Ministry of Food and Drug Safety in April.

Shinilagen plans to evaluate the safety of BAL0891 by administering it intravenously during the dose-escalation period as a single dose to patients with metastatic solid tumors, and to determine the maximum tolerated dose and the appropriate dose for phase 2 clinical trials. By 2024, after confirming the dose setting and safety of the single dose, combination therapy trials with paclitaxel will begin.

Previously, BAL0891 effectively inhibited various cancer cell lines in preclinical studies, showing superior efficacy with intravenous administration compared to oral administration. In particular, it demonstrated synergistic anticancer effects when combined with paclitaxel. The cancer models used in the experiments were moderately responsive to BAL0891 and paclitaxel individually, but a clear anticancer effect was observed with the combination of the two drugs. These research results were presented and received attention at the ‘2022 EORTC-NCI-AACR’ symposium held in Barcelona, Spain, last October.

A Shinilagen official stated, “The first patient in phase 1 clinical trials was rapidly enrolled within three months of domestic clinical approval,” adding, “We will do our utmost to ensure smooth research progress and the successful development of new drugs through close collaboration with domestic and international researchers.”

Meanwhile, Shinilagen submitted the phase 1 clinical trial of BAL0891 to the Trial in Progress section at the ‘European Society for Medical Oncology Annual Meeting 2023’ (ESMO 2023), held in Madrid, Spain, in October, and it was selected for poster presentation.

This content was produced with the assistance of AI translation services.