Cue Biopharma Announces Preclinical Safety and Tolerability Data for CUE-401 for the Treatment of Autoimmune and Inflammatory Diseases

Rhea-AI Summary

Cue Biopharma (Nasdaq: CUE) reported preclinical safety and tolerability data for lead candidate CUE-401 on Feb 17, 2026. Two non-GLP studies in mice (n=24) and non-human primates (n=6) used step-up IV dosing; all core dose levels were well tolerated with no adverse events observed.

Follow-up NHP repeat dosing showed better tolerability at 1 mg/kg versus 3 mg/kg. Management said an IND filing for CUE-401 is planned in upcoming months.

Positive

• No adverse events observed across core murine and NHP studies
• Well tolerated at all core dose levels in both species
• Planned IND filing for CUE-401 in upcoming months

Negative

• Repeat dosing at 3 mg/kg in NHPs showed reduced tolerability versus 1 mg/kg
• Small preclinical sample sizes (n=6 NHPs) limit broader safety conclusions

Key Figures

Murine study size: 24 animals Mouse dosing levels: 1, 3, 10 mg/kg NHP study size: 6 animals +5 more

8 metrics

Murine study size 24 animals Non-GLP mouse safety and tolerability study (12 males, 12 females)

Mouse dosing levels 1, 3, 10 mg/kg Escalating intravenous CUE-401 doses in murine study

NHP study size 6 animals Non-GLP non-human primate core safety study (3 males, 3 females)

NHP core dosing 0.1, 0.3, 1 mg/kg Escalating intravenous CUE-401 doses in NHP core study

NHP follow-up 1 mg/kg 1 mg/kg (n=2) Repeat dosing cohort better tolerated than 3 mg/kg cohort

NHP follow-up 3 mg/kg 3 mg/kg (n=4) Higher repeat dose showed less favorable tolerability than 1 mg/kg

No adverse events 0 adverse events No adverse events observed across murine non-GLP dosing levels

NHP adverse observations 0 adverse observations No adverse observations at 0.1–1 mg/kg in NHP core study

Market Reality Check

Price: $0.2911 Vol: Volume 352,036 is well be...

low vol

$0.2911 Last Close

Volume Volume 352,036 is well below the 1,259,710 share 20-day average, suggesting a muted positioning ahead of this news. low

Technical Shares trade below the 200-day MA, with price at 0.3066 versus MA 0.64, reflecting a longer-term downtrend.

Peers on Argus

Peers show mixed moves, with some up and others down, while CUE gained 2.2%, ind...

1 Up 2 Down

Peers show mixed moves, with some up and others down, while CUE gained 2.2%, indicating this update is more stock-specific than broad sector momentum.

Historical Context

5 past events · Latest: Feb 12 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Feb 12	Executive appointment	Positive	-6.8%	Named new Chief Financial and Business Officer to support CUE-401 strategy.
Dec 19	Dilutive offering	Negative	-21.6%	$10M underwritten public offering with common stock and warrant units.
Dec 18	Planned offering	Negative	-14.5%	Proposed underwritten offering of common stock or pre-funded warrants plus warrants.
Nov 13	Licensing deal	Positive	-7.2%	ImmunoScape in-licensed Immuno-STAT molecules for a novel WT1 tumor approach.
Nov 12	Earnings and updates	Positive	-2.3%	Q3 2025 results plus ImmunoScape collaboration and positive CUE-101 clinical data.

Pattern Detected

Financing announcements have coincided with notable price declines, while several seemingly positive corporate and partnership updates have also seen negative price reactions, suggesting a pattern of weak market confidence into news.

Recent Company History

Over the last six months, Cue Biopharma has combined business development, financings, and pipeline progress. An ImmunoScape licensing deal and Q3 2025 results highlighted collaboration cash and encouraging CUE‑101 data, yet shares fell after those updates. Two December 2025 offerings also triggered double‑digit declines. A February 2026 C-suite appointment similarly saw a negative move. Today’s CUE‑401 preclinical safety data adds to this pipeline story, but against a backdrop of prior dilutive financings and cautious market reactions to positive news.

Market Pulse Summary

This announcement highlights supportive preclinical safety and tolerability data for CUE-401 in both...

Analysis

This announcement highlights supportive preclinical safety and tolerability data for CUE-401 in both mouse and non-human primate models, with no adverse events observed across tested dosing ranges up to 10 mg/kg in mice and 1 mg/kg in the NHP core study. It reinforces CUE-401’s potential as a bifunctional tolerogenic agent ahead of a planned IND filing. Investors may watch for timing of regulatory submissions, initial clinical trial designs, and future capital-raising needs given the company’s development stage.

Key Terms

non-glp, t cells, bifunctional, tolerogenic, +3 more

7 terms

non-glp medical

"In two non-GLP studies, CUE-401 was well tolerated with no adverse events observed"

Non-GLP describes laboratory studies or tests conducted without following formal government-quality and documentation standards called Good Laboratory Practice. For investors, non-GLP results can still show early promise—think of a rough prototype or internal check—but they carry more uncertainty and usually won’t be accepted by regulators as definitive evidence, so they require confirmatory, GLP-compliant work before being relied on for approvals or major financial decisions.

t cells medical

"therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment"

T cells are a type of immune system cell that help the body identify and fight infections and abnormal cells. They act like security guards, recognizing threats and triggering responses to eliminate them. In the context of health and medicine, T cells are important because their activity can influence disease outcomes and treatments, which can impact investor interest in biotech and healthcare sectors.

bifunctional medical

"potential of CUE-401 as a first-in-class bifunctional tolerogenic agent for the treatment"

A bifunctional molecule or product performs two distinct actions at once—think of a Swiss Army knife that has both a knife and a screwdriver built into one tool. In biotech and pharmaceuticals this often means a single therapy can bind or act on two different targets or carry out two biological tasks, which can increase potential effectiveness or market value but also raise development, regulatory and safety complexity that investors should weigh.

tolerogenic medical

"CUE-401 as a first-in-class bifunctional tolerogenic agent for the treatment of autoimmune disease"

Tolerogenic describes a property of a therapy or substance that trains the immune system to accept a specific target instead of attacking it, like teaching a guard dog to ignore a family member. For investors, tolerogenic approaches matter because they promise treatments for autoimmune diseases or to prevent transplant rejection with fewer side effects and longer-lasting benefit, which can affect clinical success, regulatory risk, market size and long-term revenue potential.

investigational new drug regulatory

"details on the planned investigational new drug (IND) filing for CUE-401 in the upcoming months"

An investigational new drug is a medication that is still being tested in clinical trials to determine if it is safe and effective for treating a specific condition. For investors, it represents a potential breakthrough that could lead to a new treatment and significant financial gains if successful, but also carries risks since it has not yet been approved for widespread use.

non-human primates medical

"Two separate non-GLP studies in mice and non-human primates (NHPs) assessed the safety"

Non-human primates are members of the primate family other than people — such as monkeys and apes — that are used in biomedical research because their biology is closer to humans than rodents. For investors, results from studies in these animals can strongly influence a drug or vaccine’s safety profile, development timeline, regulatory chances and costs, acting like a high-fidelity dress rehearsal before human clinical trials.

intravenously medical

"CUE-401 was administered intravenously"

Delivered directly into a vein through a needle or tube so a medicine, fluid or diagnostic agent enters the bloodstream immediately; think of it as using a direct highway to reach the body’s circulation. For investors, the route matters because intravenous use often implies higher clinical control, faster effect, specialized administration settings and different safety, regulatory and cost implications than pills — all of which affect development timelines, pricing and market access.

AI-generated analysis. Not financial advice.

In two non-GLP studies, CUE-401 was well tolerated with no adverse events observed

Proof-of-concept studies reinforce promising preclinical profile and therapeutic potential of CUE-401

BOSTON, Mass., Feb. 17, 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 preclinical safety and tolerability data that further supports the preclinical profile of CUE-401, the Company’s lead autoimmune asset.

“We are very encouraged with this preclinical data, which demonstrated that CUE-401 was well tolerated, and no adverse events were observed,” said Usman Azam, M.D., president and chief executive officer of Cue Biopharma. “Data generated from these preclinical studies represent an important addition to the growing evidence supporting the potential of CUE-401 as a first-in-class bifunctional tolerogenic agent for the treatment of autoimmune disease. We look forward to sharing further scientific data and details on the planned investigational new drug (IND) filing for CUE-401 in the upcoming months.”

Study design and key data highlights include:
Two separate non-GLP studies in mice and non-human primates (NHPs) assessed the safety and tolerability of CUE-401 using a step-up dosing schedule, where animals successively received higher doses of CUE-401, weekly. CUE-401 was administered intravenously.

Murine Study (n=24, 12 males, 12 females)

• Animals received escalating doses of CUE-401 at 1 mg/kg, 3 mg/kg, and 10 mg/kg
• All dose levels were well tolerated, and no adverse events were observed
  
  

NHP Study (n=6, 3 males, 3 females)

• Core study: Animals received escalating doses of CUE-401 at 0.1 mg/kg, 0.3 mg/kg, and 1 mg/kg
• All dose levels were well tolerated in the core study with no adverse observations
• Follow-up dosing: Following observed tolerability and safety in the core study, animals were given an additional dose of CUE-401 a week later at 1 mg/kg (n=2 animals, 1 female, 1 male) or 3 mg/kg (n=4 animals, 2 male, 2 female)
• Repeat dosing of CUE-401 at 1 mg/kg was better tolerated than the repeat dosing at 3 mg/kg
  
  

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.

Cautionary Note Regarding 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 is a potential first-in-class bifunctional tolerogenic agent for the treatment of autoimmune disease and the company’s plans to file an IND application for CUE-401; 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

FAQ

What safety results did Cue Biopharma (CUE) report for CUE-401 on Feb 17, 2026?

CUE reported that CUE-401 was well tolerated with no adverse events observed in core studies. According to the company, two non-GLP studies in mice (n=24) and NHPs (n=6) using step-up IV dosing showed no adverse observations at core dose levels.

What doses were tested in the preclinical CUE-401 studies reported by CUE?

The murine study tested 1, 3, and 10 mg/kg; the NHP core study tested 0.1, 0.3, and 1 mg/kg. According to the company, follow-up NHP repeat doses included 1 mg/kg and 3 mg/kg to assess tolerability.

Did any repeat dosing concerns arise for CUE-401 in Cue Biopharma's NHP study?

Yes — repeat dosing at 3 mg/kg showed reduced tolerability compared with 1 mg/kg in NHPs. According to the company, repeat 1 mg/kg dosing was better tolerated than repeat 3 mg/kg in the follow-up cohort.

How large were the preclinical cohorts for CUE-401 safety testing reported by CUE?

The murine cohort was 24 animals (12 males, 12 females) and the NHP cohort was six animals (3 males, 3 females). According to the company, these sample sizes informed tolerability conclusions in non-GLP studies.

What route of administration did Cue Biopharma use for CUE-401 in the studies?

CUE-401 was administered intravenously using a step-up dosing schedule in both species. According to the company, animals received successive weekly escalating doses to assess safety and tolerability.

Will Cue Biopharma seek clinical testing for CUE-401 following these preclinical results?

The company plans to file an IND for CUE-401 in the upcoming months to enable clinical testing. According to the company, these preclinical tolerability data support the planned IND submission timeline.