Cue Biopharma is a clinical-stage biopharmaceutical company developing injectable biologics to treat autoimmune and inflammatory diseases by selectively modulating disease-relevant T cells. The core technology is the Immuno-STAT platform, a modular biologic engineering framework that targets specific immune cells rather than broadly suppressing the immune system. Cue Biopharma's lead internal program is CUE-401, a preclinical bifunctional fusion protein that combines engineered variants of TGF-β and IL-2 to convert disease-causing T cells into regulatory T cells, expand existing regulatory T cells, and reduce pro-inflammatory cells — with the goal of inducing durable immune tolerance. Cue Biopharma regained full worldwide rights to CUE-401 in March 2025 after Ono Pharmaceutical relinquished its rights. An IND filing is targeted for Q2 2026, with initial human safety data expected in the second half of 2026. Beyond CUE-401, Cue Biopharma has out-licensed two other program series: the CUE-500 series to Boehringer Ingelheim in April 2025, and the oncology-focused CUE-100 series to ImmunoScape in late 2024. Cue Biopharma generates no product revenue and funds operations through upfront and milestone payments from licensing deals. The company holds an exclusive license from Albert Einstein College of Medicine for its core technology, in exchange for royalties, sublicensing fees, and milestone payments.