SillaJen plans to conduct a clinical trial in the United States to evaluate the therapeutic effect and safety when BAL0891, which is being developed as an anticancer drug, is used together with an anticancer drug from global pharmaceutical company BiOne Medicine.
SillaJen said on the 13th that the U.S. Food and Drug Administration (FDA) has approved an amendment to its investigational new drug (IND) application to combine BAL0891 with BiOne Medicine's immune checkpoint inhibitor tislelizumab (product name Tevimbra).
SillaJen signed a strategic partnership agreement with BiOne Medicine in Jan. Under the agreement, the company will receive tislelizumab free of charge and conduct combination trials of BAL0891 in solid tumors, including triple-negative breast cancer and gastric cancer.
Through this trial, the company plans to confirm the safety and optimal dose of the BAL0891–tislelizumab combination therapy and evaluate the synergy of the two drugs.
The company said the trial was approved based on organoid (mini-organ) research results that have drawn attention following the FDA's recent policy to phase out animal testing, marking the world's first case for a combination trial.
Earlier, SillaJen presented preclinical results at the American Association for Cancer Research (AACR2025) on Apr. 4 indicating that BAL0891 modulates the tumor microenvironment in favor of antitumor immunity and may enhance the therapeutic effect of immune checkpoint inhibitors.