- Cue Biopharma (CUE, Financial) receives positive FDA feedback on its CUE-401 Pre-IND submission.
- CUE-401 is a first-in-class bispecific fusion protein targeting autoimmune diseases.
- The Company plans an IND filing following the completion of final enabling studies.
Cue Biopharma, Inc. (CUE) has announced that it received positive feedback from the U.S. Food and Drug Administration (FDA) regarding its Pre-Investigational New Drug (Pre-IND) briefing document for CUE-401, the company's lead product candidate for autoimmune diseases. The feedback paves the way for Cue Biopharma to proceed with its Investigational New Drug (IND) submission, once final enabling studies are completed.
CUE-401 is a bispecific fusion protein designed to induce and expand regulatory T cells (Tregs) through the combined activity of transforming growth factor-beta (TGF-β) and a modified variant of interleukin 2 (IL-2). This novel drug candidate aims to address unmet needs in the treatment of autoimmune diseases and represents a potentially disruptive approach in the current landscape of Treg-directed therapies.
The FDA's feedback covered key aspects of the proposed first-in-human trial, including dose escalation plans, patient populations, and safety monitoring protocols. Cue Biopharma believes that this positive feedback significantly reduces the regulatory risks associated with the upcoming IND filing process.
Dr. Dan Baker, Chief Development Officer of Cue Biopharma, highlighted the unique mechanism of CUE-401, stating that it not only increases nonspecific Treg populations but also converts specific autoreactive T cells into regulatory phenotypes, fostering immune tolerance and balance.
Despite the positive regulatory progress, Cue Biopharma remains in the early stages of development for CUE-401, with no clinical data yet available. The company continues to focus on completing the final IND-enabling studies, and anticipates that a successful IND filing will further validate its clinical development strategy.
Investors and stakeholders are closely monitoring Cue Biopharma's progress as the company moves forward with its plans to file an IND and commence clinical trials to explore the therapeutic potential of CUE-401 in treating various T-cell mediated autoimmune and inflammatory diseases.
