CUE-101

CUE-101 is a novel immunotherapeutic biologic developed by Cue Biopharma for the treatment of human papillomavirus (HPV16+)-driven recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). It is the first clinical candidate from Cue Biopharma’s Immuno-STAT platform, designed to selectively activate and expand tumor-antigen specific CD8+ T cells. The drug consists of a human leukocyte antigen complex (HLA-A*0201) loaded with a peptide epitope derived from the HPV16 E7 protein, fused to four molecules of an attenuated human interleukin-2 (IL-2) variant and an effector-attenuated IgG1 Fc domain. This structure enables targeted delivery of IL-2 to relevant tumor-specific CD8+ T cells, promoting their proliferation and activation against HPV16-expressing cancer cells while minimizing systemic toxicity. CUE-101 has been evaluated as both monotherapy and in combination with pembrolizumab in clinical trials for patients with HPV16+ HNSCC[1][3][4][6].