hondaboost
2月前
Cue Biopharma Announces 1-for-30 Reverse Stock Split
2026-04-22 08:37 ET - News Release
BOSTON, April 22, 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 implement a 1-for-30 reverse stock split of the issued shares of the company’s common stock, effective at 5:00 p.m. Eastern Time on April 23, 2026.
INV4
3月前
CUE-401 Shows Promise in Restoring Immune Balance: Cue Biopharma Highlights New Preclinical Data at IMMUNOLOGY2026
April 15, 2026
CUE-401 Highlights Innovative Immune Modulation at IMMUNOLOGY2026
At the annual IMMUNOLOGY2026 conference, Cue Biopharma is bringing fresh attention to autoimmune and inflammatory disease research with its presentation of new preclinical data on CUE-401. The company's lead candidate is designed to restore immune homeostasis by expanding and generating key regulatory T cells—a promising development for patients seeking less toxic alternatives to traditional treatments.
Mechanistic Strengths: Three-Pronged Treg Activation
The core of CUE-401's therapeutic strategy centers on three complementary mechanisms:
• Direct regulation of proinflammatory responses via its TGF-beta moiety.
• Expansion of existing regulatory T cells (Tregs) using a proprietary interleukin-2 (IL-2) mutein.
• Induction of new FOXP3+ Tregs by converting conventional CD4+ T cells—achieved by combining both TGF-beta and IL-2 signals, a pathway grounded in science recently recognized by the Nobel Prize in 2025.
New Data Supports a Pathway to Immune Tolerance
According to the company’s presentation, the latest in vivo findings demonstrate CUE-401’s ability to selectively expand functional FOXP3+ Tregs from FOXP3- conventional T cells. This data bolsters the hypothesis that CUE-401 can modulate the immune system in a manner that encourages balance—without broadly suppressing immunity. For autoimmune or inflammatory disease sufferers, targeted immune regulation represents a major step forward, potentially minimizing systemic side effects and opening doors to safer, more effective interventions.
Key Data at a Glance
Product: CUE-401
Key Mechanism: TGF-beta/IL-2 Fusion Protein
Preclinical Focus: Selective FOXP3+ Treg expansion and induction
Conference Detail:
IMMUNOLOGY2026 | Poster #733 | April 18, 2026, 11:30 a.m.
Cutting-Edge Design Rooted in Notable Science
CUE-401 stands out as a bifunctional therapeutic, merging a novel TGF-beta 'breathing-mask' moiety with an IL-2 mutein validated in prior clinical settings. This dual mechanism draws directly from Nobel Prize-winning insights into immune system tolerance and showcases Cue Biopharma's innovative approach to balancing efficacy with safety in autoimmune therapy.
Takeaway: What Investors and the Scientific Community Should Watch Next
While these new preclinical results are promising, CUE-401’s real challenge lies ahead in translating immune modulation from model systems to clinical reality. Investors and scientists will be watching for upcoming trial data and regulatory progress, especially as Cue Biopharma’s Immuno-STAT® platform continues to push for targeted, less disruptive autoimmune solutions. If CUE-401 can fulfill its early promise, it may redefine what’s possible for treating immune-driven diseases without broadly dampening the body's natural defenses.
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$CUE 🗞️
INV4
3月前
Cue Biopharma to Present New Preclinical Data on Lead Autoimmune and Inflammatory Disease Candidate CUE-401 at IMMUNOLOGY2026
April 15, 2026
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 present new preclinical data for its lead autoimmune and inflammatory disease candidate, CUE-401, as part of a poster at IMMUNOLOGY2026, the annual meeting of the American Association of Immunologists (AAI) taking place in Boston, Massachusetts, April 15-19, 2026.
Poster Presentation Details:
Title: CUE-401: A Novel Bifunctional TGF-beta/IL-2 Fusion Protein that Induces Selective Expansion of Functional, Stable FOXP3+ Tregs for the Treatment of Autoimmunity
Presenter: Natasha M. Girgis, Director, Translational Pharmacology
Date and Time: Saturday, April 18, 2026, 11:30 a.m. – 12:30 p.m. EDT
Poster Number: 733
Session: Therapeutics for Autoimmune Diseases II
Location: Exhibit Hall
As part of the presentation, Dr. Girgis will discuss new in vivo data that supports CUE-401’s ability to induce FOXP3+ antigen-specific induced T regulatory cells (iTregs) from FOXP3- conventional CD4+ T cells through the coordinated delivery of TGF-ß and interleukin-2 (IL-2) signals. This new and promising preclinical data supports CUE-401’s therapeutic potential to restore immune homeostasis in autoimmune and inflammatory diseases.
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.
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$CUE 🗞️
hondaboost
3月前
CUE, $0.25, amazing news out: up to $337.5 million royalty payments: "Pursuant to the terms of the collaboration, Cue Biopharma is also eligible to earn, in addition, up to approximately $337.5 million in additional research, development and commercial milestone-based payments as well as royalty payments on net sales."
INV4
12月前
Cue Biopharma Reports New Complete Response and Confirmed 50% Overall Response Rate in Ongoing Phase 1 Trial of CUE-101 and Pembrolizumab in Recurrent/Metastatic HPV+ Head and Neck Cancer
July 16, 2025
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 and cancer, today provided a clinical update on its most advanced asset, CUE-101, representative of the CUE-100 series.
“We are excited to report an additional CR in a patient that had recurrent metastatic HPV+ head and neck squamous cell carcinoma (HNSCC) treated with CUE-101 in combination with pembrolizumab (KEYTRUDA®),” said Matteo Levisetti, chief medical officer at Cue Biopharma. “This patient had durable stable disease for close to two years and more recently demonstrated significant tumor reductions and now a complete response. Notably, the patient had multiple sites of disease, including the lungs that cleared prior to the complete response observed in the target lesion. We believe the kinetics of tumor reduction and disease eradication in this patient is due to the repeated stimulation and expansion of tumor-specific T cells given the mechanism of action of CUE-101. It also serves as a clear example of the differences in timing of the clinical activity often observed with immunotherapy compared to traditional cytotoxic therapies and supports the prolonged mOS observed in this trial.”
Key data highlights from the expansion portion of the trial evaluating CUE-101 at the recommended Phase 2 dose (RP2D) of 4mg/kg in combination with pembrolizumab in 1L patients (data cutoff of July 14, 2025) include:
• ORR of 50% (2 CR and 10 partial responses (PR) in patients with CPS =1, compared to an ORR of 19% observed with pembrolizumab alone in the historical third-party KEYNOTE-048 trial).
• Survival metrics have continued to mature favorably: 12-month overall survival (OS) of 88% compared to 57% with pembrolizumab alone in the historical KEYNOTE-048 trial, representing a reduction in the risk of death (HR 0.23) compared to historical data.
• mOS of 32 months compared to 12.3 months in the historical KEYNOTE-048 trial.
• ORR of 50% in patients, including 50% with low PD-L1 expression CPS (1-19).
Dan Passeri, chief executive officer at Cue Biopharma, added, "The culmination of maturing data further support our conviction that CUE-101, representative of our approach with the CUE-100 series, demonstrates a potential breakthrough therapeutic approach for establishing a new standard of care. With this maturing data, we are further emboldened in our conviction that our Immuno-STAT® platform represents transformative potential for selectively modulating the patient’s immune system.”
About CUE-101 and the Phase 1 Trial
CUE-101 is Cue Biopharma’s most advanced clinical stage drug candidate from the CUE-100 series of interleukin 2 (IL-2)-based biologics. It is designed to activate and expand HPV16 tumor-specific T cells by presenting two signals or “cues” to T cells. Signal #1 incorporates the HPV E7 protein, harbored by HPV-induced cancer cells, to provide selectivity through interaction with the HPV-specific T cell receptor. Signal #2 consists of an engineered IL-2 variant to stimulate the activity of T cells. CUE-101 is currently being evaluated in a fully enrolled Phase 1 open-label, dose escalation and expansion study, for the treatment of HPV16+ driven recurrent/metastatic head and neck squamous cell carcinoma in second line (2L) and beyond patients as a monotherapy, and as a first line (1L) therapy in combination with pembrolizumab (KEYTRUDA®).
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.
Headquartered in Boston, Massachusetts, we are led by an experienced management team with deep expertise in immunology and immuno-oncology 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.
https://ih.advfn.com/stock-market/NASDAQ/cue-biopharma-CUE/stock-news/96440730/cue-biopharma-reports-new-complete-response-and-co
====================
According to the 3 analysts' twelve-month price targets for Cue Biopharma, the average price target is $3.00. The highest price target for CUE is $4.00, while the lowest price target for CUE is $2.00. The average price target represents a forecasted upside of 255.87% from the current price of $0.84.
https://www.marketbeat.com/stocks/NASDAQ/CUE/forecast/
====================
Based on short-term price targets offered by three analysts, the average price target for Cue Biopharma, Inc. comes to $4.00. The forecasts range from a low of $2.00 to a high of $6.00. The average price target represents an increase of 471.43% from the last closing price of $0.70.
https://www.zacks.com/stock/research/CUE/price-target-stock-forecast
$CUE
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