SillaJen, a Korean biotech company, said it will expand its phase 1 clinical trial of its investigational cancer drug BAL0891 in acute myeloid leukemia (AML) with five U.S. institutions, including MD Anderson Cancer Center, Yale Cancer Center, and Montefiore Medical Cancer Center, and one Korean hospital -- St. Mary’s Seoul Hospital.
SillaJen is expanding its phase 1 clinical trial of BAL0891 to acute myeloid leukemia, enlisting top U.S. and Korean cancer centers to boost the drug’s global development.
With the six additional hospitals, the total number of U.S. and Korean hospitals participating in the phase 1 clinical trial for BAL0891 in AML has risen to 13.
BAL0891 is a first-in-class dual inhibitor that targets both threonine tyrosine kinase (TTK) and polo-like kinase 1 (PLK1), enzymes essential to cancer cell division. By simultaneously blocking TTK and PLK1, the drug disrupts cell cycle progression and induces cancer cell death.
Preclinical studies using the MOLM-14 AML xenograft model have shown that BAL0891 significantly suppresses tumor growth and improves survival outcomes, even at low doses. Notably, the drug also demonstrated synergistic effects when combined with BCL-2 inhibitors, a standard therapeutic class in AML treatment.
“These compelling preclinical results have led renowned institutions such as MD Anderson and Yale Cancer Center to actively participate in the upcoming trial,” a company official said. “Their involvement is expected to enhance the clinical credibility and global competitiveness of BAL0891.”
The phase 1 trial will focus on evaluating the safety of BAL0891 monotherapy in patients with relapsed or refractory AML. The study will also determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D).
“AML is a highly recurrent and difficult-to-treat hematologic cancer, but BAL0891’s dual inhibition mechanism offers a promising strategy to overcome the limitations of current therapies,” a SillaJen official said. “We are committed to advancing BAL0891 as a next-generation treatment for both solid tumors and blood cancers.”
SillaJen aims to initiate the AML clinical trial within the year. The company also plans to present some of its preclinical AML data at an international scientific conference in the first half of this year.
Meanwhile, the company is also currently conducting clinical trials of BAL0891 in various solid tumors in Korea and the U.S.