Qureator's tumor-on-chip featured in world's first animal-free IND approval

27 October 2025

As we enter a new era of drug discovery, where IND authorization can now be granted based on human data only, marking a clean departure from mandatory animal testing, Qureator's human organ-on-chip platform has laid the groundwork for the world’s first IND approval of its kind.

The IND grant concerns SillaJen's BAL0891-tislelizumab combination therapy to treat solid tumors. Qureator's patient-derived vascularized tumor-immune microenvironment (TME) model has equipped SillaJen with preclinical evidence that small-molecule mitotic checkpoint inhibitor BAL0891 reshapes the tumor immune microenvironment, promoting a ‘cold’ to ‘hot’ transition and enhances tumor killing in combination with anti-PD-1 antibody tislelizumab.

These vascularized TME models were developed by co-culturing endothelial cells, fibroblasts, and organoids derived from renal cell carcinoma, triple-negative breast cancer, gastric cancer, and colorectal cancer patients. To evaluate the synergy between BAL0891 and checkpoint inhibitors like pembrolizumab, tumor growth, immune cell infiltration, T cell activation/exhaustion, cytokine secretion and macrophage polarization were measured in patient-derived organoids (PDO). Responsive PDO exhibited significant organoid shrinkage, increased immune cell infiltration, enhanced T cell activation, and macrophage polarization towards an anti-tumoral phenotype.

Given that animal models are not representative of human-specific features of innate and adaptive immunity, stromal and fibroblast composition and function, vascular structure, angiogenic signaling, and metabolic organisation of the tumor niche, animal testing would have likely produced misleading results. 

“Without Qureator’s collaboration, this IND approval would not have been possible,” said Seunghyun Ma, M.D., Ph.D., Chief Medical Officer of SillaJen.

“This milestone demonstrates how close collaboration between regulators and innovators can accelerate the transition to human-relevant testing,” Kyu Baek, Ph.D., CEO of Qureator highlighted. “By replacing animal POC studies with more predictive, human-based efficacy models, we are reshaping how preclinical data translate into clinical outcomes.”

Headquartered in San Diego, California, Qureator is committed to transforming the drug discovery process through integration of organ-on-a-chip technology and AI. Looking ahead, Qureator’s proprietary platforms will further support reliable assessment of therapeutic candidates, generate meaningful insights into the mechanisms of human diseases, and unlock precision medicine solutions.