FDA accepts Cue Biopharma IND for HPV-associated cancer candidate


Cue Biopharma’s (NASDAQ:CUE) IND for CUE-101, an immuno-oncology candidate for human papilloma virus (HPV)-associated cancers, had been accepted by the FDA.

The majority of HPV-associated cancers are caused by the HPV16 strain, which carries the E7 antigen. CUE-101 targets the E7 antigen and is designed to activate and expand a population of tumor-specific T cells.

Cue will initiate a Phase 1 trial in the U.S. involving some 50 patients with recurrent or metastatic head and neck squamous cell carcinoma. The trial will assess the safety and tolerability of CUE-101 and determine its recommended dose for Phase 2 trials.

“The ability to offer a therapeutic with the potential to activate and amplify cancer-specific T cells directly in a patient’s body differentiates CUE-101 from other immunotherapies in development,” Dr. Ken Pienta, Cue’s CMO, said in a statement.

The FDA’s acceptance of the CUE-101 IND triggers a $2.5-million milestone payment from Cue’s development partner, LG Chem Life Sciences.

Sydney Stewart