Head and Neck Cancer (CUE-101)

Head and Neck Cancer (CUE-101)

Cue Biopharma is evaluating the safety and anti-tumor activity of its lead clinical candidate, CUE-101, as a monotherapy in a now fully enrolled Phase 1 open-label, multicenter clinical trial for its potential use as a second line and beyond therapy, for people with human papilloma virus (HPV+16)-driven recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).

The CUE-101 monotherapy trial corresponds to Arm 1 of Cue Biopharma’s broader Phase 1 trial, consisting of a dose escalation (Part A) and expansion (Part B) portion. Arm 2 of the study is evaluating CUE-101 in combination with pembrolizumab (KEYTRUDA®) as a first line therapy in the same patient population.

For more information visit clinicaltrials.gov.

About HPV+ Recurrent or Metastatic Head and Neck Cancer

Human papilloma virus (HPV)-positive cancers account for more than 20,000 deaths each year in the U.S. and Europe1,2. The majority of these cancers are driven by HPV 16 which carries the E7 antigen targeted by CUE-1013.

Despite treatment with current standards of care, the majority of patients with metastatic disease will experience recurrence, significantly affecting quality of life and often leading to untimely death. Patients with HPV-related head and neck cancers represent an important unmet clinical need and underscore the opportunity for promising new therapeutics.


  1. US Report: https://hpvcentre.net/statistics/reports/USA.pdf?t=1628865383160
  2. Europe Report: https://hpvcentre.net/statistics/reports/XEX.pdf?t=1628865589343
  3. CUE-101 Data: https://www.who.int/news-room/fact-sheets/detail/human-papillomavirus-(hpv)-and-cervical-cancer