News Releases

News Releases

Date Title and Summary Additional Formats
Toggle Summary Cue Biopharma Initiates Patient Dosing in Phase 1 Study of CUE-101 in Combination with KEYTRUDA® (pembrolizumab) as First-line Treatment for HPV+ Recurrent/Metastatic Head and Neck Cancer
CAMBRIDGE, Mass. , Feb. 08, 2021 (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 patient’s body, announced today that on
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Toggle Summary Cue Biopharma Presents Foundational Data on Immuno-STAT Platform and CUE-101 at the Society for Immunotherapy of Cancer’s (SITC) 33rd Annual Meeting
CUE-101 Demonstrates Selective Binding and Preferential Activation/Expansion of Antigen-specific T Cells, Inhibition of Tumor Growth as Monotherapy and in Combination with a PD-1 Inhibitor CAMBRIDGE, Mass. , Nov. 09, 2018 (GLOBE NEWSWIRE) -- Cue Biopharma ™, Inc., (NASDAQ: CUE) an innovative
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Toggle Summary Cue Biopharma Presents New Positive Data from Ongoing Phase 1 Trial of CUE-101 in Combination with KEYTRUDA(R) for Recurrent/Metastatic HPV+ Head and Neck Cancer at the Society for Immunotherapy of Cancer’s (SITC) 37th Annual Meeting
Overall response rate (ORR) of 40% and a clinical benefit rate (CBR) of 70%   observed to date in first line (1L) recurrent/metastatic HNSCC patients treated with CUE-101 at the recommended Phase 2 dose and pembrolizumab. Median overall survival (mOS) approaching greater than 12 months in third
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Toggle Summary Cue Biopharma Presents New Positive Data from Phase 1 Trials of CUE-101 in Head and Neck Cancer and CUE-102 in Wilms’ Tumor 1 Positive Cancers at SITC 2023
Overall response rate (ORR) of 47% and disease control rate (DCR) of 65% in first line (1L) recurrent/metastatic HNSCC patients treated with CUE-101 and KEYTRUDA ® (pembrolizumab) ORR of 56% in patients with low expression of PD-L1 in the tumor Median overall survival (mOS) of 20.8 months in second
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Toggle Summary Cue Biopharma Presents Positive Data Update from Ongoing Phase 1 Trials of CUE-101 for Recurrent/Metastatic HPV+ Head and Neck Squamous Cell Carcinoma at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting
As of the data cutoff date, nine of the 14 evaluable patients treated with CUE-101+ KEYTRUDA® (pembrolizumab) demonstrated tumor regression, with five confirmed partial responses (PRs) and three durable stable disease (DSD) responses, two of which have tumor burden reductions of -18% and -24% and
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Toggle Summary Cue Biopharma Presents Updated Data from Lead Program CUE-101 for the Treatment of Recurrent/Metastatic HPV+ Head and Neck Cancer and Additional Pipeline Progress at the Society for Immunotherapy of Cancer’s (SITC) 36th Annual Meeting
Monotherapy data further enhances confidence in CUE-101 potential as single agent therapeutic in the refractory/metastatic human papillomavirus positive head and neck squamous cell carcinoma (HPV+ HNSCC) setting Early CUE-101 combination data with KEYTRUDA ® (pembrolizumab) supports potential
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Toggle Summary Cue Biopharma Produces Immuno-STAT™ Biologic Candidate for Treatment of Autoimmune Disease Under Collaboration and License Agreement with Merck
CAMBRIDGE, Mass. , July 12, 2018 (GLOBE NEWSWIRE) -- Cue Biopharma , Inc., an immunotherapy company developing a novel, proprietary class of biologics engineered to selectively modulate the human immune system to treat cancer and autoimmune diseases, today announced progress in its ongoing
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Toggle Summary Cue Biopharma Provides Update on Ongoing Phase 1 Trial Evaluating CUE-101 in Recurrent/Metastatic Head and Neck Cancer
Patient enrollment and data generation remain on schedule with   13 patients having received CUE-101 to date and enrollment continues per protocol to identify a recommended Phase 2 dose Dose-proportional increases in drug exposure combined with observations demonstrating pharmacodynamic biomarkers
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Toggle Summary Cue Biopharma Receives FDA Acceptance of Investigational New Drug (IND) Application for CUE-102 in Wilms’ Tumor 1 (WT1) - expressing cancers
Company to initiate Phase 1 dose escalation and expansion trial for the treatment of Wilms’ Tumor 1 (WT1) positive recurrent/metastatic cancers Starting dose of 1 mg/kg expected to reduce time and cost of dose escalation phase of trial, supporting development efficiency of CUE-100 series platform
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Toggle Summary Cue Biopharma Reports Confirmed Partial Response (PR) in Ongoing Phase 1 Monotherapy Study of CUE-101 in Late Stage Second Line and Beyond Patients with HPV+ Recurrent/Metastatic Head and Neck Cancer
And Provides Interim Clinical Data Update Partial response data demonstrates activity of CUE-101 as monotherapy in patient with human papilloma virus positive recurrent/metastatic head and neck squamous cell carcinoma (HPV+ R/M HNSCC) The objective tumor response observed in this patient
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