SillaJen Completes First Patient Enrollment in Clinical Trial for Acute Myeloid Leukemia Anticancer Drug

First Patient Enrollment for BAL0891 in Korea Completed
U.S. Clinical Trial Enrollment to Begin Soon

On September 1, SillaJen announced that it has completed the first domestic patient enrollment for its anticancer drug BAL0891 in a clinical trial targeting acute myeloid leukemia (AML).

The clinical site is Seoul St. Mary's Hospital in Seocho-gu, Seoul, and patient enrollment is expected to begin soon in the United States as well. In addition to the ongoing clinical trials for solid tumors, SillaJen will initiate trials for BAL0891 in patients with relapsed or refractory acute myeloid leukemia, aiming to determine the optimal dosage, safety, and efficacy.

Previously, BAL0891 received approval for acute myeloid leukemia clinical trials from the U.S. Food and Drug Administration (FDA) in April and from the Ministry of Food and Drug Safety (MFDS) in Korea in June. Acute myeloid leukemia is a representative type of blood cancer with a high relapse rate and poor prognosis. It is known as a particularly challenging cancer among elderly patients and those with relapsed or refractory disease.

At the European Hematology Association (EHA 2025) conference held in June, BAL0891 demonstrated promising anticancer activity in preclinical studies for acute myeloid leukemia. In the MOLM-14 acute myeloid leukemia transplantation model, BAL0891 showed significant tumor growth inhibition and increased survival rates. Notably, tumor suppression and survival benefits were observed even at low doses, and a synergistic effect was seen when combined with a BCL-2 inhibitor. Domestically, Seoul St. Mary's Hospital, recognized as a leading research institution in the field of hematologic malignancies, is participating in the clinical trial. In the United States, MD Anderson Cancer Center, Yale Cancer Center, Montefiore Cancer Center, and Sandra & Edward Meyer Cancer Center at Cornell are also participating.

A SillaJen representative stated, "As the first patient enrollment in Korea has proceeded smoothly, we expect patient enrollment in the United States to begin soon. Based on the mechanistic strength of BAL0891 as a dual inhibitor of TTK and PLK1, we will do our utmost in clinical research to provide new treatment options for patients with relapsed or refractory AML."

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