CUE-221 (UB-221)

September 20, 2026: Cue Biopharma (NASDAQ: CUE) reported positive topline Phase 2 results for CUE-221 (UB-221) in 145 patients in China with moderate to severe chronic spontaneous urticaria inadequately controlled by H1 antihistamines. In the randomized, double-blind study versus placebo and omalizumab, the primary endpoint (HSS7=0 at week 12) was met at all CUE-221 doses: 54% for 4 mg/kg, 53% for 2 mg/kg, and 43% for 1 mg/kg versus 11% for placebo (p<0.005, p<0.005, and p<0.05, respectively); omalizumab was 41% and was not statistically tested. The key secondary endpoint (UAS7=0 at week 12) reached statistical significance at 4 mg/kg: 46% versus 11% for placebo (p<0.05); 2 mg/kg and 1 mg/kg were 39% and 38%, and omalizumab was 29%.

The company said responses peaked at week 22 and that benefit at 4 mg/kg was maintained through week 28, 12 weeks after the last dose; a post hoc week 28 analysis showed a statistically significant 36% difference versus omalizumab. Safety was favorable, with no treatment-related serious adverse events, no hypersensitivity or anaphylaxis, and infrequent injection-site reactions. Cue said it is working toward rapid initiation of a Phase 2b/3 CSU study, continuing a planned Phase 2 study in food allergy, and plans to present the full 36-week dataset, including PK and IgE analyses, at an upcoming scientific meeting.