FDA accepts IND backed only by human organoid efficacy — a regulatory first

Qureator and partner SillaJen secured an FDA IND that relied solely on efficacy data generated from human vascularized tumor organoid models (vTIME), marking the first U.S. oncology IND cleared without traditional animal proof‑of‑concept studies. The FDA approval to proceed with a combination trial of oncolytic candidate BAL0891 with checkpoint inhibitors signals regulators’ increasing openness to human‑relevant preclinical models under the FDA Modernization Act 2.0. Developers said the vascularized organoid data captured drug penetration, immune interactions and combination synergy that animal models had failed to predict.