Business
Cue Biopharma Receives FDA Feedback on Pre-IND Briefing Document Reinforcing Company’s Intention to Advance IND Submission for CUE-401 to Address Unmet Need in the Treatment of Autoimmune Disease
CUE-401, a first-in-class bispecific molecule designed to induce and expand Tregs in vivo through the co-activity of transforming TGF-β and a modified variant of IL-2BOSTON, June 24, 2025 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune disease, today announced it has received Pre-Investigational New Drug (P
About this update from Cue Biopharma, Inc.
[{"type":"image","alt":"Cue Biopharma, Inc.","displaySize":"","headline":null,"caption":"Cue Biopharma, Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":110,"url":"https://media.zenfs.com/en/globenewswire.com/2e66156a6e123e96f63fe86db58bbe09"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/btk.uQvFNhbkAb9kiEpvZA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTE1NDtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/2e66156a6e123e96f63fe86db58bbe09","width":300,"height":110}},"lazy":false},{"type":"text","content":"CUE-401, a first-in-class bispecific molecule designed to induce and expand Tregs in vivo through the co-activity of transforming TGF-β and a modified variant of IL-2","length":166,"tagName":"p"},{"type":"text","content":"BOSTON, June 24, 2025 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune disease, today announced it has received Pre-Investigational New Drug (Pre-IND) feedback from the U.S. Food and Drug Administration (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 (Tregs) in vivo through the co-activity of transforming growth factor beta (TGF-β) and a modified variant of interleukin 2 (IL-2).","length":954,"tagName":"p"},{"type":"text","content":"“We are highly encouraged by the FDA’s positive feedback on our proposed development plan for this important program. We believe CUE-401, with its first-in-class mechanism exploiting the combined activities of TGF-β and IL-2 is a potentially disruptive approach differentiated from other Treg-directed therapies, and has the potential to provide durable, long-lasting immune rebalance and tolerance addressing multiple, significant disease indications,” said Daniel Passeri, chief executive officer of Cue Biopharma.","length":516,"tagName":"p"},{"type":"text","content":"Dr. Dan Baker, chief development off...