SillaJen Registers First Patient in US Phase 1 Trial of Technology-Introduced Anticancer Drug 'BAL0891'

SillaJen headquarters. [Photo by SillaJen]

Shinilajen announced on the 27th that the first patient has been enrolled in the Phase 1 clinical trial of the mitotic checkpoint inhibitor (MCI) 'BAL0891' in the United States. This marks the first patient enrollment five months after technology transfer from the Swiss pharmaceutical company Vasilia.

Shinilajen plans to evaluate the safety of BAL0891 administered intravenously during the dose-escalation period as a single dose in patients with metastatic solid tumors, and to determine the maximum tolerated dose and the appropriate dose for Phase 2 clinical trials. After confirming the single-dose setting and safety by next year, combination therapy trials with paclitaxel are scheduled to begin.

BAL0891 effectively inhibited various cancer cell lines in preclinical studies, showing superior efficacy when administered intravenously compared to oral administration. Notably, 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 at the '2022 EORTC-NCI-AACR' symposium held in Barcelona, Spain, last October.

A Shinilajen representative stated, "It is significant that the first patient was enrolled in the Phase 1 clinical trial so quickly, about five months after acquiring the candidate compound," and added, "Based on the research data secured through this US Phase 1 clinical trial, we plan to explore technology export opportunities." Shinilajen plans to conduct the clinical trial not only at the four confirmed US clinical sites for BAL0891 but also domestically in Korea.