Product Description
CUE-101 is a novel fusion protein that incorporates HLA-A*0201 allele (the MHC portion) bound to an epitope from the HPV 16 E7 protein (E711-20) and is designed to activate and expand tumor-specific T cells that target Human Papilloma Virus 16 (HPV16)-driven malignancies. (Sourced from: https://www.cuebiopharma.com/pipeline/immuno-oncology/)
Mechanisms of Action: Immunostimulant
Novel Mechanism: Yes
Modality: Fusion Protein
Route of Administration: N/A
FDA Designation: Fast Track - Head and Neck Cancer|Squamous Cell Carcinoma *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Cue Biopharma
Company Location: CAMBRIDGE MA 02139
Company CEO: Daniel R. Passeri
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: United States
Active Clinical Trial Count: 2
Highest Development Phases
Phase 2: Head and Neck Cancer|Oropharyngeal Cancer|Squamous Cell Carcinoma
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| NCT04852328 | P2 |
Recruiting |
Oropharyngeal Cancer|Head and Neck Cancer|Squamous Cell Carcinoma |
2027-10-31 |
|
| CUE-101-01 | P1 |
Active, not recruiting |
Head and Neck Cancer|Squamous Cell Carcinoma|Oropharyngeal Cancer |
2026-01-01 |