Cue Biopharma Granted Fast Track Status for CUE-101

Cue Biopharma has received Fast Track designation from the FDA for its CUE-101 drug candidate for treatment of human papilloma virus recurrent/metastatic head and neck squamous cell carcinoma as a monotherapy or in combination with Merck’s Keytruda (pembrolizumab).

CUE-101 is designed to activate and expand HPV16 tumor-specific T cells by presenting two signals or cues to the T cells, according to the company.

The investigational drug has demonstrated a favorable tolerability profile and anti-tumor activity in monotherapy as well as encouraging anti-tumor clinical activity in combination with pembrolizumab.

A phase 3 trial for CUE-101 monotherapy is expected to begin by mid-2023.