SAN DIEGO – Qureator Inc. announced a major milestone today, confirming a fundamental shift in drug development under the FDA Modernization Act 2.0. We have enabled the world’s first FDA Investigational New Drug (IND) approval in oncology based solely on human vascularized organoid efficacy data, successfully replacing traditional animal efficacy (POC) studies.
Our proprietary AI-powered vTIME (vascularized tumor immune microenvironment) organ-on-a-chip platform generated the pivotal preclinical data. This allowed our partner, SillaJen, to secure IND approval for their combination therapy, BAL0891, with an immune checkpoint inhibitor.
“This milestone demonstrates how close collaboration between regulators and innovators can accelerate the transition to human-relevant testing,” said Dr. Kyu Baek, Qureator CEO. “By replacing animal POC studies with more predictive, human-based efficacy models, we are reshaping how preclinical data translate into clinical outcomes.”
This breakthrough, also recognized by Korea’s MFDS, solidifies Qureator’s position as a global leader in next-generation preclinical platforms.