CUE - Cue Biopharma, Inc.

NasdaqGS - NasdaqGS Real-time price. Currency in USD
19.91
+1.00 (+5.29%)
At close: 4:00PM EDT

19.91 0.00 (0.00%)
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Previous close18.91
Open18.93
Bid15.00 x 800
Ask19.95 x 800
Day's range18.72 - 20.01
52-week range6.95 - 31.69
Volume290,011
Avg. volume346,382
Market cap566.436M
Beta (5Y monthly)2.18
PE ratio (TTM)N/A
EPS (TTM)N/A
Earnings dateN/A
Forward dividend & yieldN/A (N/A)
Ex-dividend dateN/A
1y target estN/A
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News
Press releases
  • GlobeNewswire

    Cue Biopharma Begins Dosing Cohort 5 in an Ongoing Phase 1 Monotherapy Trial of CUE-101 in HPV+ Recurrent/Metastatic Head and Neck Cancer

    * CUE-101 advances to cohort 5 following Safety Review Committee assessment of expanded cohort 4 * Cohort 5 is fully enrolled, with first patient having been dosed on July 20 * Additional patients to be enrolled in cohort 4 to further characterize pharmacodynamics and clinical activity in support of selecting a recommended Phase 2 doseCAMBRIDGE, Mass., July 28, 2020 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (NASDAQ: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics designed to selectively engage and modulate targeted T cells within the body, announced today it has advanced CUE-101 into cohort 5 in its ongoing multicenter, open-label, dose escalation Phase 1 monotherapy trial in patients with human papilloma virus-positive recurrent/metastatic head and neck squamous cell carcinoma (HPV+ HNSCC) (NCT03978689).Patients in cohort 5 will receive 2 mg/kg of CUE-101, which is two times the CUE-101 dose of 1 mg/kg in cohort 4. The first patient in cohort 5 received their dose and has been monitored for the initial protocol safety period of seven days with no evidence of adverse reactions. The next two patients in cohort 5 have been identified and have been scheduled to receive their first dose of CUE-101.As previously noted in a press release dated June 15, 2020, three additional patients were enrolled in cohort 4 at the recommendation of the Safety Review Committee to further characterize immune activity and confirm safety after one of the first three patients in cohort 4 experienced a possible treatment-related dose limiting toxicity (DLT). That patient subsequently received the next planned dose of CUE-101 at the same 1.0 mg/kg dosage without an observed adverse event. As no serious (Grade 3 or higher) treatment-related adverse events were observed during a 21-day safety evaluation period for the three additional cohort 4 patients, Cue Biopharma received approval from the Safety Review Committee to initiate enrollment and treatment of patients in cohort 5.“We are pleased to have enrolled three more patients in cohort 4 and to rapidly initiate cohort 5. Our progress is due, in large part, to the continued enthusiasm and support of our leading investigators during this challenging and uncertain time of COVID-19,” said Ken Pienta, M.D., acting chief medical officer of Cue Biopharma. “In parallel to evaluating CUE-101 at the cohort 5 dose level, we have identified additional patients to be enrolled in a further expansion of up to nine patients in cohort 4, as permitted per protocol. This allows us to further enhance our understanding of the pharmacokinetics (PK), pharmacodynamics (PD), and clinical activity of CUE-101 at what we believe could be a clinically active dose.”To date, sixteen patients have been dosed in the Phase 1 trial. Apart from a patient in cohort 4 with a possible treatment-related Grade 3 DLT as mentioned above, there have been no other DLTs. Importantly, the Grade 3 DLT and all other reported adverse events have resolved without further complications. To date, there have been no patient discontinuations from the trial due to adverse events.About the CUE-100 Series The CUE-100 series consists of Fc-fusion biologics that incorporate peptide-MHC (pMHC) molecules along with rationally engineered IL-2 molecules. This singular biologic is anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells directly in the patient. The binding affinity of IL-2 for its receptor has been deliberately attenuated to achieve preferential selective activation of tumor-specific effector T cells while reducing potential for effects on regulatory T cells (Tregs) or broad systemic activation, potentially mitigating the dose-limiting toxicities associated with current IL-2-based therapies.About Cue Biopharma Cue Biopharma, a clinical-stage biopharmaceutical company, is engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body to transform the treatment of cancer, infectious diseases and autoimmune diseases. The company’s proprietary Immuno-STAT™ (Selective Targeting and Alteration of T cells) platform is designed to harness the body’s intrinsic immune system without the need for ex vivo manipulation.Headquartered in Cambridge, Massachusetts, we are led by an experienced management team and independent Board of Directors with deep expertise in the design and clinical development of protein biologics, immunology and immuno-oncology treatments.For more information, visit www.cuebiopharma.com and follow us on Twitter https://twitter.com/CueBiopharma.Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the “safe harbor” created by those sections. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “potential,” “expect,” “may,” “will,” “should,” “would,” “could,” “seek,” “intend,” “plan,” “goal,” “project,” “estimate,” “anticipate,” “strategy,” “future,” “likely” or other comparable terms. All statements other than statements of historical facts included in this press release regarding our strategies, prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding anticipated results of our drug development efforts, including study results, our expectations regarding attractive therapeutic window potential, regulatory developments and expected future operating results. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, our limited operating history, limited cash and a history of losses; our ability to achieve profitability; potential setbacks in our research and development efforts including negative or inconclusive results from our preclinical studies; our ability to secure required U.S. Food and Drug Administration (“FDA”) or other governmental approvals for our product candidates and the breadth of any approved indication; adverse effects caused by public health pandemics, including COVID-19, including possible effects on our operations and clinical trials; negative or inconclusive results from our clinical studies or serious and unexpected drug-related side effects or other safety issues experienced by participants in our clinical trials; delays and changes in regulatory requirements, policy and guidelines including potential delays in submitting required regulatory applications to the FDA; our reliance on collaborators, contract research organizations, suppliers and other business partners; our ability to obtain adequate financing to fund our business operations in the future; and the other risks and uncertainties described in the Risk Factors and in Management's Discussion and Analysis of Financial Condition and Results of Operations sections of our 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 us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake 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 Ashley R. Robinson LifeSci Advisors arr@lifesciadvisors.comMedia Contact Alison Chen LifeSci Communications achen@lifescicomms.com

  • GlobeNewswire

    Cue Biopharma Announces PLOS One Publication Demonstrating the Generation and Evaluation of Novel Molecules with Directed Mutations within the B7 Superfamily

    - Novel insights into receptor binding events and interfaces have led to generation of selective molecules with unique biochemical and functional properties through an effort.

  • GlobeNewswire

    Cue Biopharma Provides Update on Ongoing Phase 1 Trial Evaluating CUE-101 in Recurrent/Metastatic Head and Neck Cancer

    Cue Biopharma, Inc. (CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics designed to selectively engage and modulate targeted T cells within the body, is providing an update on its Phase 1 trial of CUE-101 monotherapy as second-line or later therapy for patients with HPV+ recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC). As of June 15, 2020, the ongoing Phase 1, first-in-human, multicenter trial has enrolled 13 patients, with a majority of patients having received multiple cycles of therapy. Out of the 13 patients enrolled, there are six patients presently remaining on study for ongoing data generation.

  • GlobeNewswire

    Cue Biopharma to Present Corporate Overview and Pipeline Progress at Jefferies Virtual Healthcare Conference

    Cue Biopharma, Inc. (CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body, announced today it will present at the Jefferies Virtual Healthcare Conference 2020 on Thursday, June 4, 2020 at 9:00 a.m. EDT. Daniel Passeri, chief executive officer, will provide an overview of the Company’s Immuno-STAT™ (Selective Targeting and Alteration of T cells) and Neo-STAT™ platforms and an update on the on-going clinical trial for its lead drug candidate CUE-101, as well as pipeline progress and anticipated corporate development milestones. The presentation will also be archived for 30 days on the Company's website.

  • GlobeNewswire

    Cue Biopharma Reports First Quarter 2020 Results, Updates of CUE-101 Phase 1 Dose Escalation Study and Recent Business Highlights

    CAMBRIDGE, Mass., May 19, 2020 -- Cue Biopharma, Inc. (NASDAQ: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively.

  • GlobeNewswire

    Cue Biopharma to Present at AACR Virtual Annual Meeting

    Cue Biopharma, Inc. (CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body, announced today a poster presentation featuring pre-clinical data on CUE-102/A02 and CUE-102/A24, the company’s second and third drug candidates from the CUE-100 series at the American Association for Cancer Research (AACR) Virtual Annual Meeting II. CUE-102 biologics are Immuno-STATs™ (Selective Targeting and Alteration of T cells) designed to selectively target and expand Wilms’ tumor 1 (WT1) specific T cells for the treatment of patients with solid and hematological cancers.

  • GlobeNewswire

    Cue Biopharma Announces Strategic Research Collaboration with Dr. Michael Dustin and Oxford University

    Cue Biopharma, Inc. (CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body, announced today it has entered into a research collaboration agreement with Dr. Michael Dustin and the University of Oxford to determine the molecular mechanisms underlying the activity of its IL-2 based CUE-100 series Immuno-STAT™ (Selective Targeting and Alteration of T cells) Biologics. “Cue Biopharma is pleased to enter into this strategic collaboration with Dr. Dustin and the University of Oxford,” said Saso Cemerski, senior director of immuno-oncology discovery and translational immunology at Cue Biopharma.

  • GlobeNewswire

    Cue Biopharma to Host Business Update Call and Webcast

    Cue Biopharma, Inc. (CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body, announced today it will host a conference call and webcast to provide a business update on Tuesday, May 19, 2020 at 4:30 p.m. EDT. Members of the Cue Biopharma executive management team will provide an update on the Company’s platform and pipeline progress, as well as updates on its strategic objectives and anticipated milestones. Cue Biopharma, a clinical-stage biopharmaceutical company, is engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body to transform the treatment of cancer and autoimmune diseases.

  • GlobeNewswire

    Cue Biopharma Announces Clinical Trial Collaboration Agreement with Merck to Evaluate CUE-101 in Combination with KEYTRUDA® (pembrolizumab) as First-line Treatment For HPV+ Recurrent/Metastatic Head and Neck Cancer

    Cue Biopharma, Inc. (CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body, announced today it has entered into a clinical collaboration agreement with Merck (known as MSD outside the United States and Canada), through a subsidiary, to evaluate the combination of Cue Biopharma’s investigational product candidate CUE-101, a first-in-class biologic, with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with advanced head and neck cancer. Under the terms of the agreement, Cue Biopharma will conduct a Phase 1 study, KEYNOTE-A78, evaluating CUE-101 in combination with KEYTRUDA in first-line HPV+ advanced head and neck cancer.

  • GlobeNewswire

    Cue Biopharma Reports Fourth Quarter and Full Year 2019 Financial Results and Recent Business Highlights

    Extended cash runway with $33.3 million from at-the-market equity offerings in Q4’19Focused and effective execution of clinical development of CUE-101 as a Phase 1 monotherapy.

  • GlobeNewswire

    Cue Biopharma to Present at Upcoming Investor Conferences in March 2020

    Cue Biopharma, Inc. (CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body, announced today it will present at the Cowen & Co. 40th Annual Health Care Conference on Monday, March 2, 2020 in Boston, Massachusetts and the 30th Annual Oppenheimer Healthcare Conference on Wednesday, March 18, 2020 in New York. A live and archived version of the webcast will be available at http://wsw.com/webcast/cowen57/cue/.

  • GlobeNewswire

    Cue Biopharma’s Therapeutic Immuno-STAT Platform to be Featured in Merck Presentation at Antigen-Specific Immune Tolerance Drug Development Summit

    Cue Biopharma, Inc. (CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body, announced today that the company’s therapeutic Immuno-STAT™ (Selective Targeting and Alteration of T cells) platform is scheduled to be featured in a Merck presentation at the Antigen-Specific Immune Tolerance Drug Development Summit taking place on Feb. 25-27, 2020 at the Colonnade Hotel in Boston, Massachusetts. Cue entered into a strategic research collaboration and license agreement with Merck in November 2017 to develop biologics for the treatment of selected autoimmune diseases.

  • GlobeNewswire

    Cue Biopharma to Present at the Biomarkers Series UK

    Cue Biopharma, Inc. (CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body, announced today Dr. Mary Simcox, vice president of translational biology and early development, will give a presentation highlighting the strategy and  tactical details for testing CUE-101, the company’s lead biologic drug candidate, in a first-in-human Phase 1 trial (NCT03978689) at the Biomarkers Series UK taking place on Feb. 18-20, 2020 at the Manchester Central Convention Complex.

  • GlobeNewswire

    Cue Biopharma Announces Publication in Clinical Cancer Research of Preclinical and Translational Data Supporting the Therapeutic Potential of CUE-101 in HPV16-Related Malignancies

    Cue Biopharma, Inc. (CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body, announced today the publication of research demonstrating the ability of its lead biologic candidate CUE-101 to activate tumor antigen specific antitumor immunity in the peer-reviewed medical journal Clinical Cancer Research, a journal of the American Association for Cancer Research. In addition, mCUE-101 administered as a combination therapy with anti-PD-1 checkpoint inhibition further enhanced anti-tumor efficacy.

  • GlobeNewswire

    Cue Biopharma to Present at the World Vaccine & Immunotherapy Congress

    CAMBRIDGE, Mass., Dec. 02, 2019 -- Cue Biopharma, Inc. (NASDAQ: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to.

  • GlobeNewswire

    Cue Biopharma Reports Third Quarter 2019 Financial Results and Recent Business Highlights

    Initiated patient dosing in Phase 1 clinical study of lead program CUE-101 in head and neck squamous cell carcinoma (HNSCC)Extended cash runway with $11.9 million from.

  • GlobeNewswire

    Cue Biopharma to Present at Upcoming Investor Conferences in November 2019

    Cue Biopharma, Inc. (CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body, announced today that it will present at the Oncology Investor Conference on Wednesday, November 13, 2019 In New York and Stifel Healthcare Conference on Wednesday, November 20, 2019 in New York. Daniel Passeri, chief executive officer of Cue Biopharma, will provide an overview of the Immuno-STAT™ (Selective Targeting and Alteration of T cells) biologics platform for selective modulation of disease relevant T cells within the patient’s body.

  • GlobeNewswire

    Cue Biopharma Announces Upcoming Scientific Presentation at the Society for Immunotherapy of Cancer (SITC) 34th Annual Meeting

    Cue Biopharma, Inc. (CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body, announced today that it will deliver a poster presentation on its lead program, CUE-101, at the Society for Immunotherapy of Cancer 34th Annual Meeting (SITC 2019). SITC is being held on November 6-10, 2019 at the Gaylord National Hotel and Convention Center in National Harbor, Maryland. The CUE-100 series consists of Fc-fusion biologics that incorporate peptide-MHC (pMHC) molecules along with rationally engineered IL-2 molecules.

  • GlobeNewswire

    Cue Biopharma to Present at the Oppenheimer Houston Oncology Summit at the University of Texas MD Anderson Cancer Center

    Cue Biopharma, Inc. (CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body, announced today that it will present at the Houston Oncology Summit at the University of Texas MD Anderson Cancer Center on Thursday, October 17, 2019 at 10:40 a.m. CT in Houston, Texas. Daniel Passeri, chief executive officer of Cue Biopharma, will provide an overview of the clinical development plan and strategy for the company’s lead program CUE-101, which is currently being tested in a Phase 1 clinical trial for the treatment of HPV16-driven recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

  • GlobeNewswire

    Cue Biopharma Announces Changes to its Board of Directors

    Cue Biopharma, Inc. (CUE) a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body, announced today changes to its board of directors. Anthony DiGiandomenico has stepped down from the board and Aaron Fletcher, Ph.D. has been appointed, as the company executes its next phase of growth. Mr. DiGiandomenico joined Cue Biopharma as a director in June 2015, shortly after the company’s founding.

  • GlobeNewswire

    Cue Biopharma to Present at Upcoming October 2019 Scientific Conferences

    CAMBRIDGE, Mass., Oct. 09, 2019 -- Cue Biopharma, Inc. (NASDAQ: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to.

  • GlobeNewswire

    Cue Biopharma Promotes Dr. Anish Suri to President and CSO

    Cue Biopharma, Inc. (CUE) a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body, announced today the promotion of Anish Suri, Ph.D., to the role of president in addition to his current role as chief scientific officer.

  • GlobeNewswire

    Cue Biopharma to Present Corporate Overview and Update on Clinical Development Progress for CUE-101 at the Cantor 2019 Global Healthcare Conference

    Cue Biopharma, Inc. (CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body, announced today that it will present at the Cantor 2019 Global Healthcare Conference on Wednesday, October 2, 2019 at 4:10 p.m. ET in New York City. Daniel Passeri, president and chief executive officer of Cue Biopharma, will provide a corporate overview and update on the clinical development progress for the Company’s lead program CUE-101, which is currently being tested in a Phase 1 clinical trial for the treatment of HPV16-driven recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

  • GlobeNewswire

    Cue Biopharma Initiates Patient Dosing in Phase 1 Study of CUE-101 for HPV16-driven Head and Neck Squamous Cell Carcinoma

    Cue Biopharma, Inc. (CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body, announced today that on September 23, 2019 it dosed the first patient in a Phase 1 clinical trial of CUE-101 at Washington University, Alvin J. Siteman Cancer Center, St. Louis, Missouri for the treatment of HPV16-driven recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). Enabled by the company’s proprietary Immuno-STAT™ (Selective Targeting and Alternation of T cells) platform, CUE-101 is the company’s lead biologic drug candidate from the IL-2 based CUE-100 series, designed to directly engage and activate T cells in the body to target HPV-driven cancers.