BOSTON — September 20, 2026

Cue Biopharma announced positive topline results from a Phase 2 study of CUE-221 (UB-221) in patients with moderate to severe chronic spontaneous urticaria (CSU) inadequately controlled by H1 antihistamines. Conducted in China by Genesis Life Sciences, the randomized, double-blind, placebo- and active-comparator-controlled study enrolled 145 participants and evaluated three dose levels of CUE-221 against placebo and XOLAIR® (omalizumab). The trial met its primary endpoint at all three CUE-221 doses, while the key secondary endpoint was statistically significant at the highest dose, supporting plans to advance CUE-221 into a Phase 2b/3 registration-enabling study in CSU.

CUE-221 Demonstrates Dose-Responsive Resolution of Hives

At Week 12, 54% of participants receiving CUE-221 4 mg/kg achieved complete resolution of hives (HSS7=0) compared with 11% receiving placebo, with statistically significant results also observed at the 2 mg/kg and 1 mg/kg doses. For the key secondary endpoint of complete response measured by UAS7=0, 46% of patients in the 4 mg/kg group achieved complete response, compared with 11% for placebo. The 4 mg/kg group also showed sustained activity after treatment ended, with 69% achieving HSS7=0 at Week 22 and 60% maintaining complete hive resolution at Week 28, 12 weeks after the last doses.

CUE-221 Shows Distinct Activity Compared With Omalizumab

The Phase 2 data showed a differentiated efficacy profile for CUE-221 compared with the active comparator omalizumab, although the study was not designed for planned statistical testing between the two treatments. At Week 28, 60% of participants receiving CUE-221 4 mg/kg maintained complete resolution of hives compared with 24% in the omalizumab group, representing a 36-percentage-point difference in a post hoc analysis that was statistically significant. CUE-221 is designed as a precision-engineered anti-IgE antibody with a dual mechanism intended to neutralize free IgE while preserving IgE binding to CD23 on B cells, potentially reducing new IgE synthesis. The findings provide initial clinical evidence supporting the company’s mechanism-based development strategy.

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Cue Biopharma Advances CUE-221 Toward Phase 2b/3

CUE-221 demonstrated a favorable safety profile, with no treatment-related serious adverse events or hypersensitivity reactions, including anaphylaxis. Injection-site reactions were infrequent and did not lead to study discontinuation. Based on the topline findings, Cue Biopharma plans to rapidly initiate a Phase 2b/3 study in chronic spontaneous urticaria while continuing preparations for a Phase 2 study in food allergy. The company expects to present the complete 36-week dataset, including pharmacokinetic and IgE analyses, at an upcoming scientific meeting. CUE-221 is being developed under an exclusive license from Ascendant Health for territories outside China, Hong Kong, Macau and Taiwan.

Source :Cue Biopharma press release