San Diego, CA — Qureator extends its sincere appreciation to The BIO for its in-depth reporting on our landmark FDA IND approval achieved without animal PoC data. The coverage underscores a transformative moment for the global drug-development landscape and highlights the pivotal collaboration between Qureator and SillaJen.
Together with SillaJen, Qureator generated all core preclinical efficacy data for the BAL0891 + Tislelizumab combination therapy using vTIME™, our vascularized tumor-immune microenvironment model. This marks the first IND approval in the world supported exclusively by organoid-derived, AI-enhanced human-relevant data—defining a new regulatory precedent.
“Our partnership with SillaJen showcases how human-relevant platforms can replace traditional animal testing while improving predictive power,” said Kyu Baek, CEO and Co-Founder of Qureator. “This achievement signals a new era in which innovative companies and regulators work together to advance safer, faster, and more effective drug development for patients.”
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