On Tuesday, Sillajen announced that the early clinical research findings of its cancer drug BAL0891 were presented at the American Society of Clinical Oncology (ASCO).
ASCO is the world’s largest cancer conference, and this year’s annual meeting (ASCO2026) will take place from May 29 to June 2 in Chicago, Illinois.
According to the abstract published on the official website, a group of 23 patients who received ultra-low doses (5 mg) of BAL0891 successfully underwent sequential dose escalation without significant side effects, aiming to confirm safety and achieve gradual dose increases.
In a group of 8 patients who received doses above a certain level (120 mg), the efficacy of BAL0891 was observed. One patient achieved complete remission (CR), another experienced partial remission (PR), and three showed stable disease (SD). Furthermore, in the clinical group where BAL0891 was combined with paclitaxel, three patients demonstrated PR and four had SD, resulting in a high disease control rate (DCR) of 87.5%.
The company emphasized the significance of these results, noting that most patients in this clinical trial had advanced conditions with a history of two or more treatments for metastatic cancer.
The abstract revealed that the maximum tolerated dose (MTD) for monotherapy was established at 240 mg, while the recommended phase 2 dose (RP2D) was determined to be 160 mg. Sillajen believes this 80 mg safety margin between the two doses will provide a substantial advantage in future development processes.
A Sillajen spokesperson stated that while these are still early data, successfully determining the safety profile and recommended phase 2 dose (RP2D) is a significant milestone. The team of expert researchers, both in the U.S. and abroad, will continue to work diligently to demonstrate the therapeutic value of BAL0891.
Sillajen conducted phase 1 clinical trials of BAL0891 on patients with solid tumors and acute myeloid leukemia (AML) in the U.S. and South Korea. The phase 1 clinical trial was composed of four sub-trial groups (sub-trials 1-4). These included monotherapy for patients with solid tumors (sub-trial 1), combination therapy with immune checkpoint inhibitors (sub-trial 2), combination therapy with chemotherapy (sub-trial 3), and monotherapy for patients with acute myeloid leukemia (sub-trial 4).