Cue Biopharma to Present New In vitro Data for CUE-401 at the 20th World Immune Regulation Meeting (WIRM) 2026
Rhea-AI Summary
Cue Biopharma (Nasdaq: CUE) will present new in vitro data for lead asset CUE-401 at the World Immune Regulation Meeting (WIRM) in Davos, March 11–14, 2026.
The poster (Session P5) on March 12, 2026 highlights CUE-401’s TGF-β/IL-2 bifunctional design, reporting TGF-β–dependent suppression of proinflammatory cells, prevention of B cell plasma differentiation, NK cell modulation, and expansion of regulatory T cells.
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News Market Reaction – CUE
In the Mar 9 session, CUE gained 0.40%, reflecting a mild positive market reaction. Argus tracked a peak move of +5.6% during that session. Our momentum scanner triggered 5 alerts that day, indicating moderate trading interest and price volatility. Trading volume was elevated at 2.9x the daily average, suggesting notable buying interest.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Feb 17 | Preclinical safety data | Positive | -5.1% | Reported preclinical safety and tolerability data for lead asset CUE-401. |
| Feb 12 | Executive appointment | Positive | -6.8% | Appointed Lucinda Warren as Chief Financial and Business Officer. |
| Dec 19 | Public offering priced | Negative | -21.6% | Priced approximately $10 million underwritten public offering with warrants. |
| Dec 18 | Offering announced | Negative | -21.6% | Announced proposed underwritten public offering of stock and warrants. |
| Nov 13 | Licensing deal | Positive | -7.2% | Announced exclusive in-licensing deal with ImmunoScape for solid tumor program. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent positive corporate and pipeline updates often coincided with negative price reactions, while dilutive offerings also saw sharp declines.
Over the last few months, Cue Biopharma has focused on advancing CUE-401 and strengthening its capital position. On Feb 17, 2026, preclinical safety and tolerability data for CUE-401 showed no adverse events, yet shares fell after the news. A new Chief Financial and Business Officer was appointed effective Feb 9, 2026, also followed by a decline. In Dec 2025, the company announced and priced a $10 million public offering with warrants, which coincided with substantial negative price reactions. Earlier, a Nov 13, 2025 licensing deal with ImmunoScape likewise saw a post-news drop.
Key Terms
in vitro medical
tgf-beta medical
interleukin-2 (IL-2) medical
regulatory T cell medical
CD4+ T effector memory cells medical
natural killer (NK) cells medical
cytokines medical
autoimmune and inflammatory diseases medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
BOSTON, March 09, 2026 (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 and inflammatory diseases, today announced that it will deliver a poster presentation on the company’s lead asset, CUE-401, at the World Immune Regulation Meeting (WIRM) being held March 11-14, 2026 in Davos, Switzerland. The presentation will include new in vitro data that demonstrate the therapeutic potential of CUE-401 to restore immune balance for the treatment of autoimmune and inflammatory diseases.
Poster Presentation
Session: P5 – Autoimmunity and Innate Immunity
Title: CUE-401: A Novel Bifunctional TGF-beta/IL-2 Fusion Protein for the Treatment of Autoimmune and Inflammatory Diseases
Presenter: Natasha M. Girgis, Director, Translational Pharmacology
Date and Time: Day 2 – Thursday, March 12, 2026, 8:00 p.m.–11:00 p.m. CET, 3:00 p.m.–6:00 p.m. EDT
Natasha M. Girgis, Director, Translational Pharmacology will discuss new in vitro data that support CUE-401’s ability to directly inhibit proinflammatory immune cells via the direct effects of TGF-beta (TGF-β).
TGF-β is a potent immunoregulatory cytokine that maintains peripheral tolerance by inhibiting diverse types of inflammatory immune cells and proinflammatory pathways, making it an attractive therapeutic target for treating autoimmune and inflammatory diseases. In addition to expanding Tregs, we show that CUE-401 controlled proinflammatory pathways via direct effects of TGF-β on multiple cell types that contribute to autoimmune disease. In CD4+ T effector memory cells, CUE-401 showed TGF-β-dependent suppression of proinflammatory cytokines, including Th1, Th2, and Th17 responses. In addition, the TGF-β in CUE-401 prevented activated B cells from differentiating into plasma cells and limited antibody production. In natural killer (NK) cells, TGF-β in CUE-401 counterbalanced the activating effects of interleukin-2 (IL-2), preventing proliferation and upregulation of proinflammatory cytokine production. Together, we believe these results demonstrate that CUE-401 has the potential to provide both short-term control of diverse inflammatory processes via TGF-β, while also potentially providing durable long-term benefit through the induction and expansion of regulatory T cell responses.
About CUE-401
CUE-401 is a novel bifunctional therapeutic that incorporates an innovative TGF-beta breathing-mask moiety with Cue Biopharma’s clinically validated interleukin-2 (IL-2) mutein in a single injectable biologic. The design of CUE 401 was inspired by Nobel Prize winning science in 2025 for the role of IL-2 and TGF-beta as essential components in helping establish immune tolerance by regulating FOXP3 signaling. CUE-401 is designed to promote immune regulation and tolerance by three complementary mechanisms: 1. Direct regulation of proinflammatory mechanisms by TGF-beta, 2. Expansion of existing Tregs by IL-2, and 3. Conversion of FOXP3- conventional CD4+ T cells into FOXP3+ induced Tregs through the coordinated provision of TGF-beta and IL-2 signals, both of which are required for the de novo induction of FOXP3 expression.
About Cue Biopharma
Cue Biopharma, a clinical-stage biopharmaceutical company, is developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient’s body. The company’s proprietary platform, Immuno-STAT® (Selective Targeting and Alteration of T cells) and biologics are designed to harness the curative potential of the body’s intrinsic immune system without the adverse effects of broad systemic immune modulation. CUE-401, the company’s lead autoimmune asset, is designed to act mechanistically both as a regulator of proinflammatory mechanisms, and as a master switch for regulatory T cell (Treg) differentiation to induce tolerance. It is a highly innovative, tolerogenic bifunctional molecule combining a TGF-beta breathing-mask moiety with Cue Biopharma’s clinically validated interleukin 2 (IL-2) mutein in a single injectable biologic.
Headquartered in Boston, Massachusetts, we are led by an experienced management team with deep expertise in immunology and protein engineering as well as the design and clinical development of protein biologics.
For more information please visit www.cuebiopharma.com and follow us on X and LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, those regarding: the company’s belief regarding the potential benefits and applications of its drug candidates and programs, including the company’s plans to further advance its differentiating Immuno-STAT® platform and lead autoimmune asset, CUE-401; the company’s belief that CUE-401 has the therapeutic potential to restore immune balance for the treatment of autoimmune and inflammatory diseases; and the company’s business strategies, plans and prospects. Forward-looking statements, which are based on certain assumptions and describe the company’s future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “would,” “could,” “seek,” “intend,” “plan,” “goal,” “project,” “estimate,” “anticipate,” “strategy,” “future,” “likely,” “promise” or other comparable terms, although not all forward-looking statements contain these identifying words. All statements other than statements of historical facts included in this press release regarding the company’s strategies, prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. Important factors that could cause the company’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the company’s ability to maintain its collaboration with ImmunoScape; the company’s limited operating history, limited cash and a history of losses; the company’s ability to obtain adequate financing to fund its business operations in the near term and successfully remediate its current “going concern” determination that it does not have sufficient capital on hand to continue operations beyond the next twelve months; the company’s ability to achieve profitability; potential setbacks in the company’s research and development efforts including negative or inconclusive results from its preclinical studies or clinical trials or the company’s ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; serious and unexpected drug-related side effects or other safety issues experienced by participants in clinical trials; its ability to secure required U.S. Food and Drug Administration (“FDA”) or other governmental approvals for its product candidates and the breadth of any approved indication; adverse effects caused by public health pandemics, including possible effects on the company’s operations and clinical trials; delays and changes in regulatory requirements, policy and guidelines including potential delays in submitting required regulatory applications to the FDA; the company’s reliance on licensors, collaborators, contract research organizations, suppliers and other business partners; the company’s ability to obtain adequate financing to fund its business operations in the future and ability to continue as a going concern; the company’s ability to maintain and enforce necessary patent and other intellectual property protection; competitive factors; general economic and market conditions and the other risks and uncertainties described in the Risk Factors and Management's Discussion and Analysis of Financial Condition and Results of Operations sections of the company’s most recently filed Annual Report on Form 10-K and any subsequently filed Quarterly Report(s) on Form 10-Q. Any forward-looking statement made by the company in this press release is based only on information currently available to the company and speaks only as of the date on which it is made. The company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Investor Contact
Marie Campinell
Senior Director, Corporate Communications
Cue Biopharma, Inc.
mcampinell@cuebio.com
Media Contact
Jonathan Pappas
LifeSci Communications
jpappas@lifescicomms.com
