Qureator Organ-on-Chip Breakthrough Marks Milestone Under FDA Modernization Act 2.0
World’s First IND Approval in Oncology Based Solely on Human Vascularized Organoid Efficacy Data Confirms Shift Toward Human-Relevant Preclinical Testing
SAN DIEGO, Calif. – October 27, 2025 – Qureator Inc., a San Diego–based innovator in AI-powered, human-relevant organ-on-a-chip platforms, today announced that its proprietary vascularized tumor immune microenvironment model (vTIME) generated pivotal preclinical efficacy data that enabled SillaJen to secure U.S. Food and Drug Administration (FDA) approval of an Investigational New Drug (IND) application for a combination therapy of BAL0891 with immune checkpoint inhibitors.
This landmark decision represents the world’s first FDA IND approval in which efficacy data were generated solely from human vascularized organoid–based combination studies, without relying on traditional animal efficacy (POC) testing—underscoring a fundamental shift toward human-relevant efficacy evaluation under the FDA Modernization Act 2.0.
“This milestone demonstrates how close collaboration between regulators and innovators can accelerate the transition to human-relevant testing,” said Kyu Baek, Ph.D., CEO of Qureator. “By replacing animal POC studies with more predictive, human-based efficacy models, we are reshaping how preclinical data translate into clinical outcomes.”
Transforming Preclinical Testing With vTIME
Qureator’s vTIME is a 3D tumor organoid technology that accurately recreates human vascular structures and immune environments. Compared with conventional organoids, vTIME offers superior modeling of drug effects, penetration, distribution, and immune responses. Enhanced with Qureator’s Quricore AI engine, the platform integrates human data to improve clinical predictability at the preclinical stage.
In the joint study with SillaJen, a pronounced synergistic effect was observed when combining the anticancer drug BAL0891 with an immune checkpoint inhibitor. The results were presented at the American Association for Cancer Research (AACR) 2025 Annual Meeting in April. Based on these data, SillaJen submitted an IND amendment to evaluate BAL0891 with Tislelizumab (developed by BeOne Medicine, formerly BeiGene Ltd.), which the FDA approved on October 6, 2025.
The study was led by Dr. Sanghee Yoo, Qureator’s Head of Biology, whose team developed the vascularized tumor–immune co-culture system that generated the efficacy data supporting the IND filing.
Regulatory Momentum: Animal Efficacy Testing Phase-Out
The FDA has announced a phased reduction in animal efficacy testing and is actively promoting the use of New Approach Methodologies (NAMs). In parallel, the National Institutes of Health (NIH) has announced a new policy direction to reduce reliance on animal-only models, encouraging human-based alternatives. Together, these agencies are encouraging the industry to adopt more human-relevant approaches for preclinical decision-making.
Vascularized organoid models such as vTIME are emerging as next-generation preclinical platforms, enabling precise reconstruction of human tissue and detailed analysis of drug delivery and immune cell interactions. Industry interest has surged since the FDA’s NAM initiatives, positioning Qureator and SillaJen as early leaders in this paradigm shift.
Global Regulatory Validation
The milestone has drawn attention beyond the United States. The Ministry of Food and Drug Safety (MFDS) of Korea has also reviewed and approved Qureator’s organoid-based efficacy data, marking one of the earliest regulatory recognitions of human-relevant models in Korea. This dual validation from the FDA and MFDS reinforces Qureator’s position as a global leader in next-generation preclinical platforms.
Fruit of a Strategic Partnership
SillaJen’s proactive partnership with Qureator—initiated with a joint research agreement in June 2024—was instrumental in achieving this milestone.
“Without Qureator’s collaboration, this IND approval would not have been possible,” said Seunghyun Ma, M.D., Ph.D., Chief Medical Officer of SillaJen. “Through their innovative vascularized organoid model, we’ve demonstrated that global regulatory agencies can approve efficacy studies without traditional animal POC testing.”
Looking Ahead: Expanding Organ-on-Chip Collaboration
Qureator plans to broaden its research collaborations to further support the FDA Modernization Act 2.0. The company will showcase ongoing advancements of its vTIME platform—which utilizes human and patient-derived tissues within an organ-on-chip system—at the Society for Immunotherapy of Cancer (SITC) Annual Meeting, November 5–9, 2025, at the Gaylord National Resort & Convention Center in National Harbor, Md.
For more information about Qureator please visit our website at qureator.com or email us at [email protected]