Cue Biopharma's 8-K confirms Phase 2 CUE-221 data in chronic hives, outlines next steps

Cue Biopharma filed an 8-K on September 21, 2026 disclosing the Phase 2 CUE-221 (UB-221) results it had announced a day earlier for chronic spontaneous urticaria (CSU), along with detail on regulatory next steps. The Phase 2 clinical trial in CSU was conducted in China by Genesis Life Sciences, an affiliate of Ascendant Health Ltd.¹ The trial enrolled 145 participants with moderate to severe CSU whose disease remained inadequately controlled despite treatment with H1-antihistamines.¹

The multicenter, randomized, double-blind, placebo and active comparator-controlled study ran a 16-week treatment period with a 20-week follow-up, randomizing patients 2:2:2:1:1 to subcutaneous CUE-221 at 4 mg/kg, 2 mg/kg, or 1 mg/kg every four weeks, or placebo every four weeks, or omalizumab 300 mg every four weeks.¹ The primary endpoint was the proportion of patients achieving HSS7=0 at week 12, and a key secondary endpoint assessed complete response defined as UAS7=0 at week 12.¹

The primary endpoint was dose-responsive and met at all three CUE-221 dose levels, while the secondary UAS7=0 endpoint was also dose-responsive and reached statistical significance at the 4 mg/kg level.¹ At week 12, complete resolution of hives (HSS7=0) occurred in 54% of the 4 mg/kg group, 53% of the 2 mg/kg group, 43% of the 1 mg/kg group, 11% of placebo, and 41% of the omalizumab arm.¹ After the last dose at week 16, benefit was maintained through week 28 in the 4 mg/kg group, and a post hoc analysis at that timepoint showed a statistically significant 36-percentage-point difference versus omalizumab.¹

CUE-221 demonstrated a favorable safety profile, with no treatment-related serious adverse events, no hypersensitivity reactions including anaphylaxis, and infrequent injection site reactions, none of which led to discontinuation.¹

Cue said it recently submitted an IND to the FDA for food allergy and, subject to the FDA's review of the CSU trial data, intends to initiate a Phase 2 trial in food allergy and a Phase 2b/3 trial in CSU.¹