Cue Biopharma received positive Pre-Investigational New Drug (Pre-IND) feedback from the FDA for CUE-401, a first-in-class bispecific molecule designed to treat autoimmune diseases by inducing and expanding regulatory T cells (Tregs). The FDA reviewed the proposed first-in-human trial design, including dose escalation, target populations, and safety monitoring, paving the way for an IND filing upon completion of final enabling studies. CUE-401 utilizes a novel mechanism combining transforming growth factor beta (TGF-β) and a modified variant of interleukin 2 (IL-2).
This positive feedback represents a crucial step toward potentially transforming autoimmune disease treatment. Current therapies often focus on broad immunosuppression, leading to significant side effects. CUE-401’s targeted approach, focused on expanding and modulating Tregs, offers the possibility of restoring immune balance with improved safety and long-term disease management. This targeted mechanism holds promise for addressing the root cause of autoimmune diseases rather than just managing symptoms.
CUE-401 is a preclinical, bispecific fusion protein that leverages the combined power of TGF-β and IL-2, essential factors for Treg development and stability. This approach aims to not only expand existing Tregs but also convert autoreactive T cells (cells that attack the body’s own tissues) into disease-specific Tregs, creating a “tolerance positive feedback loop.” Preclinical models suggest that CUE-401 effectively converts inflammatory cells into regulatory ones, addressing the underlying dysfunction driving autoimmune diseases.
This FDA feedback validates Cue Biopharma’s approach and sets the stage for clinical investigation of CUE-401. Successful development could lead to a new class of autoimmune therapies with improved efficacy and safety profiles, potentially offering patients a more durable and targeted treatment option. A successful clinical trial would be a significant step forward for Cue Biopharma and the broader field of Treg-based therapies, potentially establishing a new standard of care for autoimmune diseases.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
