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DRUG:

CUE-101

i
Other names: CUE-101, CUE 101, LR19127, CUE101, LR-19127, LR 19127
Company:
Cue Biopharma, LG Chem
Drug class:
IL-2 stimulant
Related drugs:
7ms
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
7ms
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
1year
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
over1year
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
over1year
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
over1year
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
2years
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
2years
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
over2years
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
over2years
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
almost3years
Clinical • Enrollment open
|
CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma)
|
CDKN2A expression
|
CUE-101
3years
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
over3years
Clinical • New P2 trial
|
CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma)
|
CDKN2A expression
|
CUE-101
4years
[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
4years
[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
almost5years
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