SillaJen is making strides in its new drug development by presenting interim results for its next-generation cancer treatment BAL0891 at the European Society for Medical Oncology Annual Congress (ESMO 2026).
The company announced on Monday that it shared interim analysis results from a Phase 1 clinical trial of BAL0891, which involved 54 patients with advanced solid tumors, at ESMO 2026 in Madrid, Spain.
BAL0891 is a groundbreaking first-in-class dual inhibitor that simultaneously targets TTK and PLK1, enzymes crucial for cell division. This study analyzed data from ongoing Phase 1 trials in South Korea and the U.S., examining both standalone therapy and combination treatment with paclitaxel.
The analysis revealed that BAL0891 was generally well-tolerated. Neutropenia, the primary adverse effect, was manageable through dose adjustments and supportive care. Most non-hematological side effects were mild. Notably, no treatments were discontinued or deaths occurred due to drug-related adverse reactions.
Early signs of antitumor activity were observed. In the paclitaxel combination group, the objective response rate (ORR) was 21.4%, with a disease control rate (DCR) of 78.6%. Remarkably, in the monotherapy group, one bladder cancer patient achieved a complete response (CR) that lasted over seven months.
It’s worth noting that 81.5% of trial participants had undergone systemic chemotherapy at least twice before. Given that stable disease was observed even in heavily pre-treated patients, SillaJen plans to further investigate the treatment’s potential in upcoming clinical trials.
In a significant development this August, BAL0891 received orphan drug designation from the U.S. Food and Drug Administration (FDA) for acute myeloid leukemia (AML) treatment.
Beyond its current solid tumor trials, SillaJen is also evaluating a combination therapy of the immunotherapy drug tislelizumab with BAL0891.
The company is broadening its cancer drug development scope by initiating a BAL0891 monotherapy clinical trial for AML patients.
SillaJen intends to leverage BAL0891’s clinical data to pursue discussions with global pharmaceutical companies for potential technology transfer and collaborative development.
A SillaJen spokesperson stated that it has determined the maximum tolerated dose for BAL0891 monotherapy and observed promising initial antitumor activity when combined with paclitaxel. It’s now focusing on refining the future clinical development strategy based on these findings and continuing talks for global partnerships.