Cue Biopharma
Pipeline
Precision Immuno-Engineering for
Allergic and Autoimmune Disease
The immune system plays a critical role in maintaining health by preventing inappropriate immune responses against the body’s own tissues while protecting against external threats.
Allergic and autoimmune diseases arise when these regulatory mechanisms break down, leading to overactive or misdirected immune responses.
Current therapies often manage these conditions by blocking IgE-mediated or downstream inflammatory pathways or by broadly suppressing immune activity. Significant unmet needs remain in the overall efficacy, durability of response and safety, as well as the convenience of currently available therapies.
As a result, there remains a need for more selective approaches and novel mechanisms of action that precisely target the underlying drivers of disease.
Our Pipeline
At Cue Biopharma, we have two distinct lead programs, CUE-221 and CUE-401, that are connected by a common scientific construct that we describe as precision immuno-engineering. These investigational therapies are deliberately designed to modulate the immune system in biologically informed ways. This approach is central to both programs and forms a cohesive portfolio with the potential to impact patients across both allergic and autoimmune diseases.
Program
Allergy
Autoimmune & Inflammation
Undisclosed Programs
*Additional partnered programs include CUE 501 which is licensed to Boehringer Ingelheim and the CUE-100 Series which is licensed to ImmunoScape.
Pipeline Assets
CUE-221
CUE-221 is an investigational anti-IgE molecule with a unique dual-mechanism-of-action and the potential to be used across all IgE-mediated allergic diseases. It is a functionally distinct novel anti-IgE antibody that not only neutralizes free IgE with high potency, but also down regulates new IgE production. In a Phase 1 single ascending dose study, CUE-221 showed robust and durable IgE suppression as well as clinically meaningful efficacy signals in patients with Chronic Spontaneous Urticaria (CSU) that is consistent with its mechanism of action. CUE-221 has a well-tolerated safety profile. Cue’s initial global indication will be in food allergy.
Kuo et al. J Clin Invest. 2022
CUE-401
CUE-401 is an investigational potential first-in-class bifunctional cytokine designed to restore immune balance in autoimmune disease. It combines affinity-attenuated interleukin 2 (IL-2) and transforming growth factor beta (TGF-β) signaling within a single molecule. Its goal is to deliver the combined signals required to selectively promote regulatory T cell biology, including both the expansion of naturally occurring Tregs and the conversion of effector T cells into inducible FOXP3+ regulatory T cells. CUE-401 has the potential to address a broad range of autoimmune diseases by restoring immune balance rather than broadly suppressing immune function.
Our science is advancing.
The need is now.
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