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    DRUG:

    CUE-101

    i
    Other names: CUE-101, CUE 101, LR19127
    Company:
    Cue Biopharma, LG Chem
    Drug class:
    IL-2 stimulant
    Related drugs:
    16d
    A Phase 1 Study in Patients With HPV16+ Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P1, N=85, Active, not recruiting, Cue Biopharma | Trial completion date: Dec 2023 --> May 2025 | Trial primary completion date: Sep 2023 --> Nov 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    PD-L1 expression • CDKN2A expression
    |
    Keytruda (pembrolizumab) • CUE-101
    29d
    Three Schedules of CUE-101 Administered Before Surgery or Definitive Chemoradiation Therapy in HLA-A*0201 Positive Patients With Locally Advanced, HPV16-Positive Oropharyngeal Squamous-Cell Carcinoma (clinicaltrials.gov)
    P2, N=30, Recruiting, Washington University School of Medicine | Trial completion date: Oct 2025 --> Oct 2027 | Trial primary completion date: Oct 2025 --> Oct 2027
    Trial completion date • Trial primary completion date • Surgery • Metastases
    |
    CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma)
    |
    CDKN2A expression
    |
    CUE-101
    8ms
    A Phase 1 Study in Patients With HPV16+ Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P1, N=85, Active, not recruiting, Cue Biopharma | Recruiting --> Active, not recruiting | Trial primary completion date: Jun 2023 --> Sep 2023
    Enrollment closed • Trial primary completion date • Combination therapy • Metastases
    |
    CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    PD-L1 expression • CDKN2A expression
    |
    Keytruda (pembrolizumab) • CUE-101
    1year
    A phase 1 dose-escalation and expansion study of CUE-101, a novel HPV16 E7-pHLA-IL2-Fc fusion protein, given as monotherapy and in combination with pembrolizumab in patients with recurrent/metastatic HPV16+ head and neck cancer. (ASCO 2023)
    CUE-101 facilitates the targeted delivery of high concentrations of IL-2 to relevant tumor-specific CD8+ T cells. We demonstrate safety and tolerability with encouraging PD signals and antitumor activity with monotherapy and in combination with pembrolizumab in HPV+ R/M HNSCC patients. Enrollment continues in the CUE-101 and pembrolizumab combination cohort.
    Clinical • P1 data • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • IL2 (Interleukin 2)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • CUE-101
    1year
    A Phase 1 Study in Patients With HPV16+ Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P1, N=85, Recruiting, Cue Biopharma | Trial completion date: Aug 2023 --> Dec 2023 | Trial primary completion date: Feb 2023 --> Jun 2023
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    PD-L1 expression • CDKN2A expression
    |
    Keytruda (pembrolizumab) • CUE-101
    1year
    Circulating free HPV16 DNA as a potential biomarker for immunotherapy-based trials in HPV16+ head and neck squamous cell carcinoma (AACR 2023)
    Our data support the continued assessment of HPV16 cfDNA as an exploratory biomarker in patients receiving immunotherapy to better understand correlations with radiographic response assessments and overall clinical benefit.
    IO biomarker
    |
    IL2 (Interleukin 2)
    |
    CUE-101
    over1year
    A phase 1 study of CUE-101, a novel HPV16 E7-pHLA-IL2-Fc fusion protein, as monotherapy and in combination with pembrolizumab in patients with recurrent/metastatic HPV16+ head and neck cancer (SITC 2022)
    Of the 10 evaluable patients treated with CUE-101 plus pembrolizumab, 3 patients experienced PR (2 confirmed) and 2 patients SD for ≥ 12 weeks. Conclusions CUE-101 has a manageable safety profile and demonstrates activity alone and in combination with pembrolizumab.
    Clinical • P1 data • Combination therapy
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • IL2 (Interleukin 2)
    |
    Keytruda (pembrolizumab) • CUE-101
    over1year
    Three Schedules of CUE-101 Administered Before Surgery or Definitive Chemoradiation Therapy in HLA-A*0201 Positive Patients With Locally Advanced, HPV16-Positive Oropharyngeal Squamous-Cell Carcinoma (clinicaltrials.gov)
    P2, N=30, Recruiting, Washington University School of Medicine | Trial completion date: Oct 2024 --> Oct 2025 | Trial primary completion date: Oct 2024 --> Oct 2025
    Trial completion date • Trial primary completion date
    |
    CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • CD8 (cluster of differentiation 8)
    |
    CDKN2A expression
    |
    CUE-101
    almost2years
    A Phase 1 Study in Patients With HPV16+ Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P1, N=85, Recruiting, Cue Biopharma | Trial primary completion date: Jul 2022 --> Feb 2023
    Trial primary completion date • Combination therapy
    |
    CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    PD-L1 expression • CDKN2A expression
    |
    Keytruda (pembrolizumab) • CUE-101
    2years
    A phase 1 dose-escalation and expansion study of CUE-101, a novel HPV16 E7-pHLA-IL2-Fc fusion protein, given alone and in combination with pembrolizumab in patients with recurrent/metastatic HPV16+ head and neck cancer. (ASCO 2022)
    CUE-101 is a novel immunotherapeutic that facilitates the targeted delivery of high concentrations of IL-2 to relevant tumor-specific CD8+ T cells. We demonstrate safety and tolerability with encouraging PD signals and antitumor activity. Enrollment continues in the combination cohort.
    Clinical • P1 data • Combination therapy
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • IL2 (Interleukin 2)
    |
    Keytruda (pembrolizumab) • CUE-101
    over2years
    Three Schedules of CUE-101 Administered Before Surgery or Definitive Chemoradiation Therapy in HLA-A*0201 Positive Patients With Locally Advanced, HPV16-Positive Oropharyngeal Squamous-Cell Carcinoma (clinicaltrials.gov)
    P2, N=30, Recruiting, Washington University School of Medicine | Not yet recruiting --> Recruiting
    Clinical • Enrollment open
    |
    CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma)
    |
    CDKN2A expression
    |
    CUE-101
    over2years
    A phase 1 trial of CUE-101, a novel HPV16 E7-pHLA-IL2-Fc fusion protein, alone and in combination with pembrolizumab in patients with recurrent/metastatic HPV16+ head and neck cancer (SITC 2021)
    Conclusions CUE-101 is a novel immunotherapeutic demonstrating acceptable safety and tolerability with encouraging PD signals, supporting selective activation of tumor-specific T cells, and promising antitumor activity. Enrollment continues in both monotherapy and combination cohorts.
    Clinical • P1 data • Combination therapy • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • IL2 (Interleukin 2) • GZMB (Granzyme B)
    |
    PD-L1 expression • HLA-A*02:01
    |
    Keytruda (pembrolizumab) • CUE-101
    3years
    Three Schedules of CUE-101 Administered Before Surgery or Definitive Chemoradiation Therapy in HLA-A*0201 Positive Patients With Locally Advanced, HPV16-Positive Oropharyngeal Squamous-Cell Carcinoma (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, Washington University School of Medicine
    Clinical • New P2 trial
    |
    CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma)
    |
    CDKN2A expression
    |
    CUE-101
    over3years
    [VIRTUAL] A phase 1 trial of CUE-101 a novel HPV16 E7-pHLA-IL2-Fc fusion protein in patients with recurrent/metastatic HPV16+ head and neck cancer (SITC 2020)
    Neither the MTD nor the monotherapy RP2D have been established. PD and PK analyses are ongoing as dose escalation continues.
    Clinical • P1 data
    |
    CD8 (cluster of differentiation 8) • IL2 (Interleukin 2)
    |
    CUE-101
    over3years
    [VIRTUAL] A phase 1 trial of CUE-101 a novel HPV16 E7-pHLA-IL2-Fc fusion protein in patients with recurrent/metastatic HPV16+ head and neck cancer (SITC 2020)
    Neither the MTD nor the monotherapy RP2D have been established. PD and PK analyses are ongoing as dose escalation continues.
    Clinical • P1 data
    |
    CD8 (cluster of differentiation 8) • IL2 (Interleukin 2)
    |
    CUE-101
    over4years
    CUE-101, a Novel HPV16 E7-pHLA-IL-2-Fc Fusion Protein, Enhances Tumor Antigen Specific T Cell Activation for the Treatment of HPV16-Driven Malignancies. (PubMed, Clin Cancer Res)
    Consistent with its design, CUE-101 demonstrates selective expansion of an HPV16 E7-specific population of cytotoxic CD8T cells, a favorable safety profile, and in vitro and in vivo evidence supporting its potential for clinical efficacy in an ongoing Phase 1 trial (NCT03978689).
    Journal
    |
    IL2 (Interleukin 2)
    |
    CUE-101