10 hours ago
Cue Biopharma receives Pre-IND feedback from FDA for CUE-401
Cue Biopharma (CUE) announced it has received Pre-Investigational New Drug, or Pre-IND, feedback from the FDA. The FDA reviewed the first-in-human trial design, including the Company's plan for dose escalation, proposed populations and safety monitoring plan. On the basis of the FDA feedback, the Company, intends to file an IND pending completion of final IND enabling studies. CUE-401 is the Company's lead autoimmune asset, a first-in-class bispecific fusion protein/molecule designed to induce and expand regulatory T cells in vivo through the co-activity of transforming growth factor beta and a modified variant of interleukin.
