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Cue Biopharma Inc - CUE STOCK NEWS

Welcome to our dedicated page for Cue Biopharma news (Ticker: CUE), a resource for investors and traders seeking the latest updates and insights on Cue Biopharma stock.

Company Overview

Cue Biopharma Inc (symbol: CUE) is a clinical‐stage biopharmaceutical company at the forefront of innovative immunotherapy. Specializing in developing a novel class of therapeutic biologics, the company designs and engineers agents that selectively engage and modulate disease‐specific T cells. By targeting specific antigen‐expressing cells, Cue Biopharma aims to treat a broad range of cancers and autoimmune disorders while potentially reducing the adverse effects associated with broad systemic immune modulation. The company leverages its proprietary Immuno-STAT platform to create therapies that are not only precise in their action but are also designed to rapidly move from discovery to clinical validation through a streamlined development process.

Innovative Immuno-STAT Platform and Pipeline

The core of Cue Biopharma’s strategy lies in its Immuno-STAT platform, a technology that enables the modification of T cell activity through a customizable peptide exchange mechanism. This approach allows the company to design biologics that are capable of engaging specific T cell populations associated with a variety of disease indications. Unlike traditional treatments that may cause widespread immune activation, the selective targeting minimizes unintended effects, offering an advantage in terms of both safety and efficacy.

Within its diversified pipeline, Cue Biopharma is investigating several product candidates. Its lead candidates, such as CUE-101 and CUE-102, are being developed for oncology applications with a focus on HPV-driven head and neck squamous cell carcinoma and tumors expressing specific markers such as Wilms’ Tumor 1. In parallel, the company is also advancing programs in the autoimmune and inflammatory disease sectors, demonstrating the flexibility of its platform across different therapeutic areas.

Business Model and Clinical Strategy

Operating as a clinical-stage biopharmaceutical company, Cue Biopharma generates revenue primarily through strategic collaborations with industry partners. These collaborations support the company’s advancement of clinical trials and provide an operational runway as its product candidates progress through early-phase trials. The company’s business model emphasizes a cost-efficient approach to drug development by leveraging existing, validated drug frameworks for rapid therapeutic candidate selection and clinical validation.

In the realm of clinical development, Cue Biopharma focuses on designing trials that carefully evaluate both monotherapy and combination therapy strategies. For instance, its approach to pairing CUE-101 with established checkpoint inhibitors in oncology trials is a testament to its commitment to enhancing treatment efficacy. The trial designs incorporate careful dose escalation and expansion strategies that help establish a robust safety and efficacy profile necessary for advancing toward later-stage development.

Competitive Positioning and Industry Relevance

In the competitive and rapidly evolving field of immuno-oncology, Cue Biopharma’s commitment to precision in immune modulation distinguishes its therapeutic approach. By concentrating on the selective activation of disease-specific T cells, the company avoids the pitfalls of broad systemic activation that can lead to significant toxicities in conventional therapies. This strategic focus not only positions the company uniquely among its peers but also underscores its potential to address significant unmet medical needs in oncology and autoimmunity.

The company’s approach also emphasizes flexibility. The ability to rapidly exchange peptides within its Immuno-STAT platform means that Cue Biopharma can efficiently recalibrate its therapeutics to address different antigens relevant to various cancers and autoimmune diseases. This adaptability is critical in an era where precision medicine is rapidly transforming treatment paradigms.

Experienced Leadership and Scientific Expertise

Cue Biopharma is guided by an experienced management team and a board of directors with deep expertise in immunology, immuno-oncology, and biologics development. The leadership team’s track record in drug development, combined with an advisory board comprising renowned scientists and clinicians, enhances the company’s credibility. This collective expertise supports a rigorous, science-driven approach to clinical development and underpins the company’s strategy to transform therapeutic standards in challenging disease areas.

Key appointments and strategic transitions within the company further reflect its commitment to innovative clinical and registrational strategies. Such organizational enhancements are aimed at strengthening the company’s operational capabilities and ensuring that sound scientific and clinical principles continue to guide its development efforts.

Research Collaborations and Strategic Partnerships

Recognizing the importance of collaborative research, Cue Biopharma has established partnerships with prominent pharmaceutical companies and leading academic institutions. These partnerships have facilitated access to advanced research tools and clinical trial infrastructures, thereby accelerating the pace of clinical validation for its product candidates. The collaboration with major industry partners not only enhances resource efficiency but also contributes to a broader validation of its novel therapeutic approach.

These alliances enable the company to integrate diverse expertise, ranging from regulatory affairs to clinical trial management, ensuring that its innovations are rigorously evaluated and refined. Through these strategic engagements, Cue Biopharma further reinforces its position as a dynamic and scientifically robust player in the immunotherapy space.

Key Therapeutic Advantages and Operational Efficiency

The potential therapeutic advantages of Cue Biopharma’s approach are multifold. First, by selectively targeting antigen-specific T cell populations, its biologics offer the promise of improved clinical outcomes with a lower incidence of adverse effects. The rational design of its products—incorporating attenuated interleukin signals to fine-tune immune activation—illustrates a sophisticated approach to overcoming the limitations seen in conventional immunotherapies.

Secondly, the company’s ability to streamline the drug development process through a modular platform design could lead to more efficient clinical validation and cost-effective therapeutic candidate progression. This operational efficiency is central to the company’s long-term mission of transforming therapeutic approaches in both oncology and autoimmunity.

Conclusion

In summary, Cue Biopharma Inc stands as a notable entrant in the biopharmaceutical arena, leveraging advanced immunotherapy techniques to develop precise, selective biologics. With a robust Immuno-STAT platform, a diversified clinical pipeline, and a leadership team endowed with substantial industry experience, the company is methodically addressing some of the most challenging therapeutic areas including cancer and autoimmune diseases. Its strategic collaborations and innovative drug development model are designed to bridge the gap between scientific discovery and clinical application, thereby demonstrating significant potential for establishing new standards in patient care.

This comprehensive profile aims to provide investors, industry analysts, and stakeholders with a clear understanding of Cue Biopharma’s business model, technological advancements, and market positioning. By continuing to focus on precision immunotherapy and strategic clinical development, the company reinforces its commitment to scientific excellence and operational efficiency in an increasingly competitive landscape.

  • Innovative Platform: Utilizes a modular approach to target disease-specific T cells.
  • Diversified Pipeline: Focused on both oncology and autoimmune indications.
  • Strategic Collaborations: Engages in partnerships to accelerate clinical development.
  • Operational Efficiency: Streamlined drug development process reducing timelines and costs.
  • Experienced Leadership: Driven by industry veterans with proven track records.

The detailed overview provided here is intended to serve as a resource that encapsulates the company’s evolving strategy, technological innovation, and competitive edge, forming a solid foundation for understanding Cue Biopharma’s unique contributions to the field of immunotherapy.

Rhea-AI Summary

Cue Biopharma (Nasdaq: CUE) announced plans to present at the 2021 Federation of Clinical Immunology Societies Annual Meeting from June 8-11, 2021. Anish Suri, the company's president, will discuss preclinical data on CUE-401, aimed at treating autoimmune diseases. CUE-401 is a bispecific molecule designed to induce regulatory T cells (iTregs) in vivo. The presentation is scheduled for June 10, 2021, and will highlight its effectiveness in inducing iTregs from healthy donors and patients with autoimmune conditions like rheumatoid arthritis.

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Cue Biopharma (CUE) has announced its participation in the Jefferies Virtual Healthcare Conference from June 1-4, 2021. The company will showcase its advancements, particularly focusing on CUE-101, an Immuno-STAT™ therapeutic being tested for HPV+ recurrent/metastatic head and neck cancer. Additionally, Cue Biopharma will discuss CUE-102, a drug candidate targeting Wilms Tumor 1 (WT1), with an IND filing expected in the first half of 2022. The presentation is scheduled for June 3, 2021, at 8:30 a.m. EDT, and will be available for live streaming.

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On May 17, 2021, Cue Biopharma provided a clinical and business update for Q1 2021. The company reported a confirmed partial response in a patient from its Phase 1 monotherapy trial of CUE-101, with stable disease observed in five patients. Cue Biopharma's collaboration revenue increased to approximately $1.6 million, while R&D expenses slightly decreased to $9.8 million. The firm strengthened its financial position by raising $10.4 million through its ATM facility. The company ends Q1 2021 with cash and equivalents of $73.3 million, supporting operations through Q4 2022.

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Cue Biopharma (CUE) has announced a conference call and webcast scheduled for May 17, 2021, at 4:30 p.m. EDT to share a business update. This includes a clinical update on the ongoing Phase 1a/1b trial of CUE-101, with emphasis on a confirmed partial response in a patient treated for HPV+ recurrent/metastatic head and neck squamous cell carcinoma. The management will also discuss recent advancements in their technology platform and strategic objectives. Investors can access the event via the company's website.

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Cue Biopharma (CUE) announced interim clinical data from its Phase 1a/1b study of CUE-101, showing a confirmed partial response (PR) in a patient with HPV+ recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). This marks initial clinical proof of concept for its Immuno-STAT™ platform, highlighting activity in modulating the anti-tumor T-cell repertoire. The study reported favorable tolerability and evidence of immune cell activation. The company plans to discuss these findings in its upcoming quarterly update on May 17, 2021.

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On May 6, 2021, Cue Biopharma (Nasdaq: CUE) announced it will present at the virtual New York Academy of Sciences 2021 Frontiers in Cancer Immunotherapy meeting from May 12-14, 2021. The presentation will focus on the Immuno-STAT™ platform, designed to enhance anti-tumor immune responses, alongside its expanding pipeline including lead candidate CUE-101, which targets HPV+ head and neck squamous cell carcinoma. Dr. Steve Quayle will discuss clinical data demonstrating favorable activity for CUE-101 and introduce CUE-102, targeting WT1, expected to enter clinical trials in 2022.

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Cue Biopharma provided a business update for Q4 and full-year 2020, focusing on their ongoing clinical trials and financial performance. The company initiated the Phase 1 trial for CUE-101, both as monotherapy and in combination with KEYTRUDA, showing promising early results in treating HPV+ R/M HNSCC. However, collaboration revenues decreased from $3.5 million in 2019 to $3.2 million in 2020. R&D expenses rose to $33.5 million, reflecting increased clinical activity, and the company reported a net loss of $44.8 million.

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Cue Biopharma (Nasdaq: CUE) announced its participation in the Oppenheimer 31st Annual Healthcare Conference from March 16-18, 2021. The company will present a corporate update on March 18, 2021, at 9:20 a.m. EDT, focusing on the clinical progress of CUE-101, its lead therapeutic for HPV+ recurrent/metastatic head and neck cancer. Additionally, they will discuss advancements in the CUE-400 series, targeting various autoimmune diseases. The presentation will be available via webcast and archived for 30 days on their website.

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Cue Biopharma, based in Cambridge, Massachusetts, announced a conference call on March 16, 2021, at 4:30 p.m. EDT, to provide a business update. The call will cover updates on the CUE-101 Phase 1 dose escalation trial and the KEYNOTE-A78 combination trial with KEYTRUDA for HPV+ recurrent head and neck cancer. Additionally, the management will discuss pipeline developments and strategic milestones. Investors can join via phone or webcast, with details available on the company’s website.

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Cue Biopharma, a clinical-stage biopharmaceutical company, announced its participation in the Cowen 41st Annual Health Care Conference from March 1-4, 2021. The company will present an overview of its innovative Immuno-STAT™ platform, highlighting key developments, including updates on its Phase 1 trial for CUE-101 monotherapy and its combination trial with KEYTRUDA® for treating HPV+ recurrent/metastatic head and neck cancer. The presentation is scheduled for March 4, 2021, at 9:10 a.m. EST, and will be available via webcast.

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FAQ

What is the current stock price of Cue Biopharma (CUE)?

The current stock price of Cue Biopharma (CUE) is $0.7661 as of April 11, 2025.

What is the market cap of Cue Biopharma (CUE)?

The market cap of Cue Biopharma (CUE) is approximately 43.9M.

What is the primary focus of Cue Biopharma Inc?

Cue Biopharma Inc is focused on developing a novel class of biologic drugs that selectively modulate disease-specific T cells to treat a range of cancers and autoimmune disorders.

How does the Immuno-STAT platform work?

The Immuno-STAT platform involves engineering biologics that present specific peptides to activate and expand disease-specific T cells, thereby offering targeted therapeutic effects while minimizing adverse off-target immune responses.

Which therapeutic areas does the company target?

The company targets both oncology and autoimmune diseases, with specific programs addressing cancers such as head and neck squamous cell carcinoma and disorders associated with inflammatory and autoimmune conditions.

How does Cue Biopharma generate revenue?

Revenue is primarily generated through strategic collaborations with industry partners and through milestones achieved during the clinical development of its product candidates.

What differentiates Cue Biopharma from its competitors?

Cue Biopharma differentiates itself by leveraging its proprietary platform that enables selective modulation of T cells, potentially reducing systemic side effects and accelerating the drug development process.

What role does clinical research play in the company’s strategy?

Clinical research is central to the company’s strategy; rigorous phase 1 studies and combination therapy trials help establish both the safety and efficacy profiles of its novel biologics.

What is the significance of strategic partnerships for Cue Biopharma?

Strategic partnerships allow Cue Biopharma to leverage external expertise and resources, facilitating accelerated clinical development, resource sharing, and broader validation of its innovative therapeutic approach.

How does the company ensure operational efficiency in drug development?

By utilizing a modular and flexible platform for rapid peptide exchange within established drug frameworks, the company streamlines its development process, potentially reducing time and costs compared to traditional methodologies.
Cue Biopharma Inc

Nasdaq:CUE

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CUE Stock Data

43.85M
61.47M
0.55%
18.58%
1.51%
Biotechnology
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