SillaJen Receives MFDS IND Approval for Combination Clinical Trial of BAL0891 and Tislelizumab
Full-Scale Launch of Combination Strategy with Immune Checkpoint Inhibitors
On September 10, SillaJen announced that it has received approval from the Ministry of Food and Drug Safety for an amendment to its Investigational New Drug (IND) application to conduct a combination clinical trial of its anticancer drug 'BAL0891' with tislelizumab, an anti-PD-1 immune checkpoint inhibitor developed by global pharmaceutical company BeiGene.
Earlier this year in January, SillaJen signed an agreement with BeiGene to receive tislelizumab free of charge, and the company plans to conduct combination clinical trials targeting patients with solid tumors in both the United States and South Korea.
The two companies will focus on confirming the safety and optimal dosage of the BAL0891 and tislelizumab combination therapy through this trial, as well as evaluating the synergistic effect. Their goal is to verify the potential of BAL0891 as an optimal combination partner for immune checkpoint inhibitors. Depending on the clinical research results, they hope to provide new treatment options for patients with solid tumors who have limited therapeutic choices.
SillaJen has previously demonstrated the combination effect of BAL0891 with immune-oncology drugs through various studies. Notably, at the American Association for Cancer Research (AACR 2025) held in April, the company presented research showing that the immune response was significantly enhanced and cancer cell death was markedly increased when BAL0891 was administered in combination with an immune-oncology (anti-PD-1) antibody. Furthermore, the same synergistic effect was observed in models resistant to immune-oncology antibodies, suggesting that BAL0891 could be a strategy to overcome resistance to immune-oncology drugs.
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A SillaJen representative stated, "With this approval for the combination clinical trial, both companies will do their utmost to provide superior treatment options for patients with solid tumors," adding, "We will actively pursue clinical approval in the United States as soon as possible, following the approval in South Korea."
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