Cue Biopharma (CUE) R&D Day 2026 summary

Pipeline overview and program updates

• CUE-401 is the lead candidate for autoimmune and inflammatory diseases, with manufacturing and IND-enabling activities completed and IND filing planned for Q2 2026.

• CUE-501, licensed to Boehringer Ingelheim, achieved its first preclinical milestone, triggering a $7.5M payment and up to $345M in potential milestones plus royalties.

• CUE-100 series was licensed to ImmunoScape, with a $15M upfront payment, high single-digit royalties, and a 40% equity stake; ImmunoScape is advancing toward additional IND submissions.

Clinical trial data and development milestones

• IND-enabling studies for CUE-401, including a four-week GLP toxicology study, are complete; IND submission is planned for June 2026.

• Phase 1 study for CUE-401 will start in Q3 2026, with single and multiple ascending dose arms in healthy volunteers; initial readouts expected by Q4 2026 and Q2 2027.

• Preclinical models show CUE-401 increases, expands, and stabilizes Tregs, suppresses effector T cell function, and provides durable immune tolerance in autoimmune disease models.

• Efficacy demonstrated in models of multiple sclerosis, GVHD, and hypersensitivity, supporting broad clinical applicability.

R&D strategy and innovation priorities

• Focus is on autoimmune disease programs, leveraging the Immuno-STAT platform and precision immunoengineering to restore immune tolerance by targeting Tregs with bifunctional cytokine therapeutics.

• CUE-401 incorporates key functional components from earlier CUE-100 series, combining attenuated IL-2 and TGF-β3 to selectively expand and activate Tregs while minimizing off-target effects.