Quarterly Report · 10-Q
Cue Biopharma, Inc.
CUENASDAQEQUITYCurrent
Quarterly Report
Company context
CUE-221 (Ascendant-221, UB-221) is a humanized anti-IgE IgG1 monoclonal antibody designed with a precision engineered dual mechanism of action. CUE-221 binds to IgE at sites that are distinct from the binding sites for other anti-IgE monoclonal antibodies. In doing so, it maintains the capacity of total IgE to bind the CD23 receptor at the surface of B cells, resulting in reduced IgE synthesis. Therefore, CUE-221 is a functionally distinct novel anti-IgE antibody designed to not only neutralize free IgE with high potency, but also prevents the synthesis of new IgE which could ultimately result in functional cure if IgE is eradicated. The CUE-221 Phase 2 clinical trial in CSU produced positive topline results and clinical evidence providing initial validation of the clinical potential of a precision engineered anti-IgE dual mechanism of action. The study also demonstrated fundamental biological differences compared to current therapies. Based on these data, we are planning to advance CUE-221 in a Phase 2b/3 study in chronic spontaneous urticaria and in a Phase 2 study in food allergy.