Cue Biopharma (CUE) Status Update summary

Platform and program updates

• Highlighted the unique biologics platform designed to restore immune balance by selectively modulating T cell populations for cancer and autoimmune diseases.

• CUE-401, a first-in-class bispecific targeting TGF-β and IL-2, demonstrated robust induction and expansion of regulatory T cells (Tregs) and reduction of effector T cells in preclinical models.

• CUE-401 showed durable suppression of autoimmunity and long-term immune tolerance in multiple animal models, including autoimmune gastritis, GVHD, EAE, and DTH.

• CUE-501 collaboration with Boehringer Ingelheim validated the CUE-500 series for B-cell depletion in autoimmune disease, with retained rights for other indications.

• CUE-100 oncology series continues to show encouraging survival benefits, supporting potential strategic partnerships.

Mechanistic and translational insights

• CUE-401 uniquely enables simultaneous, conditional signaling of TGF-β and IL-2, overcoming previous challenges with cytokine toxicity and manufacturability.

• Preclinical data confirmed CUE-401 induces stable, suppressive Tregs from both naïve and memory T cells, with robust expansion and phenotypic stability.

• CUE-401 outperformed IL-2 mutants by inducing new Tregs and not expanding effector T cells, translating to superior efficacy in disease models.

• Non-human primate studies showed even greater Treg expansion at lower doses, with excellent tolerability and no adverse safety signals.

• The platform's modular design allows targeting of various pathogenic cell types, with ongoing exploration of additional cell lineages for future programs.

Clinical and strategic outlook

• IND-enabling studies for CUE-401 are underway, with indication prioritization guided by preclinical efficacy and commercial opportunity.

• CUE-401 is positioned as a potential new standard of care for autoimmune and inflammatory diseases, aiming for durable immune reset and drug-free remission.

• The approach is not holistically immunosuppressive, reducing risk of broad immunosuppression seen with current therapies.

• Monitoring of Treg expansion and immune signatures will enable personalized, durable dosing strategies in future clinical trials.

• Resources are expected to support key strategic developments, with further updates anticipated as programs advance.