Qureator announced that the FDA has cleared an IND for SillaJen’s BAL0891 combination based primarily on efficacy data generated with Qureator’s vascularized tumor immune microenvironment (vTIME) organoid platform — the first U.S. oncology IND relying solely on human vascularized organoid efficacy without traditional animal proof‑of‑concept data. The approval, enabled under the FDA Modernization Act 2.0 framework, signals regulatory openness to validated human‑relevant preclinical models. Qureator’s vTIME integrates 3D vascular structures and immune components and is coupled with AI analytics to assess drug penetration, immune engagement and combinatorial effects. The platform produced synergistic efficacy when BAL0891 was combined with checkpoint blockade, data the FDA accepted for an IND amendment to evaluate BAL0891 plus tislelizumab. This milestone may accelerate adoption of organoid and organ‑on‑chip approaches in regulatory submissions and reduce reliance on animal efficacy studies where validated human models can demonstrate translational relevance. Sponsors, CROs and regulators will watch subsequent clinical performance to determine how broadly this pathway will be applied.