Cue Biopharma, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CUE-101, its lead clinical drug candidate from the CUE-100 series of interleukin 2 (IL-2)- based biologics, for the treatment of patients with human papilloma virus (HPV16+) recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) as a monotherapy and in combination with pembrolizumab (KEYTRUDA(R)). Fast Track is a process designed to facilitate the development and expedite the review of drug candidates to treat serious conditions and fulfill an unmet medical need. A therapeutic candidate that receives Fast Track designation may be eligible for more frequent interactions with the FDA to discuss the therapeutic candidate's development plan.

Therapeutic candidates with Fast Track designation may be eligible for accelerated approval and priority review if supported by clinical data. CUE-101 is currently being evaluated in a Phase 1b trial (NCT03978689) as a monotherapy for the treatment of second line and beyond patients with HPV16+ R/M HNSCC and as a first-line treatment in a Phase 1 dose escalation and expansion trial in combination with KEYTRUDA(R) for the same patient population.