Cue Biopharma gets FDA fast track status for CUE-101 in HPV16+ R/M HNSCC


Cue Biopharma has been granted fast track designation for CUE-101 from the US Food and Drug Administration (FDA) for the treatment of a type of head and neck squamous cell carcinoma (HNSCC) both as a monotherapy and in combination with Merck’s pembrolizumab (KEYTRUDA).

The fast track designation for the interleukin 2 (IL-2)-based biologic is in human papilloma virus (HPV16+) recurrent/metastatic head and neck squamous cell carcinoma.

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Presently, CUE-101 is being assessed in a phase 1b clinical trial as a monotherapy for the treatment of HPV16+ R/M HNSCC in the second line and beyond setting.

For the same patient population, the interleukin 2 (IL-2)-based biologic is also being evaluated as a first-line treatment in a phase 1 dose escalation and expansion trial in combination with KEYTRUDA.

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Dr. Matteo Levisetti — Cue Biopharma Clinical Development senior vice president said: “We are very pleased to have received Fast Track designation from the FDA for CUE-101. This designation not only underscores the large unmet need for patients with R/M head and neck cancer who currently rely on available non-targeted therapies, but also highlights the potential of CUE-101 to provide a significant clinical benefit.

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“To date in its Phase 1b clinical trials, CUE-101 has demonstrated a favorable tolerability profile and single-agent anti-tumor activity in monotherapy as well as encouraging anti-tumor clinical activity in combination with pembrolizumab, supporting the potential to improve overall survival (OS) for these patients.”

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