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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
Globenewswire· 2025-06-24 20:48
Core Insights - Cue Biopharma, Inc. has received positive Pre-IND feedback from the FDA regarding its lead autoimmune asset, CUE-401, a first-in-class bispecific molecule designed to induce and expand regulatory T cells (Tregs) in vivo [1][2] - CUE-401 utilizes the combined activities of transforming growth factor beta (TGF-β) and a modified variant of interleukin 2 (IL-2) to potentially provide durable immune rebalance and tolerance for various autoimmune diseases [2][4] Company Overview - Cue Biopharma is a clinical-stage biopharmaceutical company focused on developing a novel class of therapeutic biologics that selectively engage and modulate disease-specific T cells for autoimmune disease treatment [1][8] - The company’s proprietary platform, Immuno-STAT™, aims to harness the body's intrinsic immune system without the adverse effects of broad systemic immune modulation [8] Product Details - CUE-401 is engineered to enhance the Treg induction capacity of TGF-β combined with IL-2 signaling, which is believed to improve the quality and stability of Tregs [5][6] - The design of CUE-401 allows for "conditional binding," which minimizes off-target activity and simplifies manufacturing processes [6] Mechanism of Action - CUE-401 acts as a master switch to convert autoreactive effector T cells into stable, induced T-regulatory cells (iTregs), establishing a 'tolerance positive feedback loop' that increases nonspecific Treg populations while reducing autoreactive T cells [7]
Kilburg: My word of the day is rebalance
CNBC Television· 2025-06-18 12:24
All right, Jeeoff, we got to start here. Has the thesis changed at all with everything that's going on in the Middle East. I I have a feeling that you researched and put this piece together before all this quite ramped up.Yes, you're absolutely right, Frank. And it is tough from a micro perspective to look at every tweet that comes out. It seems like the market is kind of tilting hour by hour, but I think in the bigger picture, this March higher to retest these S&P 500 all-time highs is underway.Call it a m ...
Bill Ackman Loads Up On Uber, Dumps Nike In Major Q1 Portfolio Rebalance
Benzinga· 2025-05-15 21:52
Bill Ackman could have a new love for the automotive sector with a new investment made in the first quarter and an added position to a stake from the fourth quarter of 2024 that was revealed in April.Here's a look at Ackman's investment holdings in Pershing Square as of March 31.First Quarter Changes: Ackman and Pershing Square unveiled a new stake in Uber Technologies UBER in the first quarter with a position of more than 30 million shares. The stake is now the largest holding the Pershing Square portfolio ...