SillaJen Receives FDA IND Approval for Combination Trial of BAL0891 and Tislelizumab

On October 13, 2025, SillaJen announced that it has received approval from the U.S. Food and Drug Administration (FDA) for a change to its Investigational New Drug (IND) application, allowing the combination clinical trial of its anticancer drug 'BAL0891' with 'Tislelizumab,' an immune checkpoint inhibitor developed by global pharmaceutical company BiOne Medicine (formerly BeiGene).

With this approval, SillaJen plans to actively proceed with the combination clinical trial of BAL0891 and the immune checkpoint inhibitor in the United States. This clinical trial is based on the strategic partnership established with BiOne Medicine in January, under which SillaJen will receive Tislelizumab free of charge to conduct combination trials targeting solid tumors with BAL0891.

This combination trial aims to verify both the safety and optimal dosage of the BAL0891 and Tislelizumab combination therapy, while also evaluating the synergistic effects to assess BAL0891's potential as an optimal partner for immune checkpoint inhibitors. Depending on the clinical research results, the company hopes to offer new treatment options for patients with limited choices, such as those with triple-negative breast cancer (TNBC) and gastric cancer (GC).

SillaJen has previously demonstrated the efficacy of combining BAL0891 with immune-oncology drugs through various studies. Notably, at the American Association for Cancer Research (AACR 2025) held in April, the company presented preclinical research suggesting that BAL0891 can modulate the tumor microenvironment to favor antitumor immunity and enhance the therapeutic effect of immune checkpoint inhibitors. According to the research, a highly reliable Bayesian statistical method confirmed a 'decisive' level of synergy when BAL0891 was administered in combination with the immune checkpoint inhibitor. This clinical trial is also the world's first combination trial approved based on organoid-based research results, which have gained attention due to the recent policy shift toward phasing out animal testing.

A SillaJen representative stated, "With this FDA approval, we can officially begin the combination clinical trial of BAL0891 and the immune checkpoint inhibitor. Our research team will do their utmost, in close collaboration with global clinical institutions, to provide outstanding treatment options for patients with refractory solid tumors."

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