ShillaJen Unveils 'BAL0891 and Immuno-Oncology Drug' Combination Strategy at SITC

On November 10, ShillaJen announced that two research findings on 'BAL0891', a first-in-class anticancer drug, were presented at the annual meeting of the Society for Immunotherapy of Cancer (SITC 2025) in the United States.

The Society for Immunotherapy of Cancer (SITC) is the world's largest conference specializing in immuno-oncology, attended by leading global anticancer drug developers and key researchers. This year, the event was held in Maryland, United States, from November 5 to 9. At this conference, ShillaJen received attention by presenting concrete scientific evidence for the unique immunomodulatory mechanism of 'BAL0891' and its combination strategy with immuno-oncology drugs.

The presented studies quantitatively analyzed the immune activity of 'BAL0891' using a three-dimensional tumor microenvironment (3D organoid) platform that simulates human tissue. The research team confirmed that 'BAL0891' induces immune cell infiltration into the tumor, increases the secretion of pro-inflammatory cytokines, and activates the innate immune cGAS-STING pathway, thereby enhancing the tumor's immune responsiveness.

In particular, by modeling a dual curve where immune activation and T-cell suppression responses intersect at different drug concentrations, the simulation showed that the greatest synergistic effect with immune checkpoint inhibitors was observed 3 to 5 days after administration in the 3D organoid model. This is considered to be an 'optimized approach to immuno-oncology combination therapy', rather than a simple analysis.

Additionally, at this conference, ShillaJen unveiled the outline of a Phase 1 clinical trial combining 'BAL0891' with Biomedicine's immune checkpoint inhibitor 'Tislelizumab' in patients with advanced solid tumors. This dose-escalation study will be conducted at multiple sites in the United States and Korea with approximately 30 participants, aiming to evaluate safety and tolerability, and to determine the recommended Phase 2 dose (RP2D) and maximum tolerated dose (MTD).

'BAL0891' will be administered intravenously on days 1 and 15 of a 3-week cycle, while 'Tislelizumab' will be administered in combination on day 8. The drug dosage will be determined using a Bayesian statistical method with high scientific reliability to establish the MTD and RP2D. This clinical trial aims to verify whether the synergistic effect between 'BAL0891' and immune checkpoint inhibitors, demonstrated in preclinical studies, can also produce significant results in the clinical setting. Full-scale patient enrollment is scheduled to begin early next year.

A ShillaJen representative stated, "This presentation marks an official global recognition of the scientific potential of BAL0891 and the rationale for combination immuno-oncology strategies. We will focus our research capabilities to deliver meaningful results and provide new therapeutic alternatives for patients."

This content was produced with the assistance of AI translation services.