Sillajen Applies for 'BAL0891' Combination Clinical Approval to US FDA

[Financial News] Sillajen announced on the 16th that it has applied for a change in the clinical trial plan (IND) to combine the anticancer drug BAL0891 with the immune checkpoint inhibitor Tislelizumab from global pharmaceutical company Biowon Medicine.
This clinical trial is based on the strategic partnership signed with Biowon Medicine last January. According to the contract, Sillajen will receive Tislelizumab free of charge from Biowon Medicine and conduct combination clinical trials with BAL0891 for solid cancer patients in both the United States and Korea.
BAL0891 is a mitotic checkpoint inhibitor (MCI) introduced by Sillajen from Basilea, Switzerland. It is the first-in-class anticancer drug that simultaneously inhibits two phosphorylation enzymes, PLK1 and TTK, which affect tumor growth.
Currently, phase 1 clinical trials are underway in the United States and Korea, and the clinical target has recently expanded to include acute myeloid leukemia (AML), pushing for an expansion of indications to blood cancers.
Tislelizumab, developed by Biowon Medicine, has proven efficacy in various solid cancers such as advanced esophageal cancer, non-small cell lung cancer (NSCLC), and hepatocellular carcinoma (HCC), rapidly expanding its market share in the global immuno-oncology market.
Sillajen presented preclinical results announced at the American Association for Cancer Research (AACR 2025) last April as evidence supporting the scientific validity of this combination clinical trial.
In this study, BAL0891 alone was found to induce the infiltration of immune cells into the tumor microenvironment and promote the secretion of inflammatory cytokines, confirming the mechanism of activating immune responses.
Furthermore, when combined with a PD-1 inhibitor, the cancer cell-killing effect was significantly enhanced, and Bayesian statistical analysis also derived a 'decisive' level of confidence in the combination effect, proving the potential of the combination strategy.
A Sillajen representative stated, “The global development strategy of BAL0891 is on a full-fledged track,” adding, “We expect to offer meaningful treatment options in the field of refractory solid cancers through the combination with Tislelizumab.”


vrdw88@fnnews.com Kang Joong-mo Reporter