Cue Biopharma Inc. (CUE) Granted FDA Fast Track Designation for CUE-101 for the Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of injectable biologics designed to selectively engage and modulate tumor-specific T cells directly within the patient’s body, announced today 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®).

“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,” said Dr. Matteo Levisetti, senior vice president, Clinical Development of Cue Biopharma. “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. We look forward to providing periodic updates and remain committed to advancing the development of CUE-101 to provide patients with a potentially more effective and better tolerated treatment option. We anticipate initiating a registrational trial for CUE-101 monotherapy by mid-2023.”

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® for the same patient population.

About HPV+ Recurrent or Metastatic Head and Neck CancerHuman papilloma virus (HPV)-positive cancers account for more than 20,000 deaths each year in the U.S. and Europe. The majority of these cancers are driven by HPV16 which carries the E7 antigen targeted by CUE-101. Despite treatment with current standard of care, the majority of patients with metastatic disease will experience recurrence, significantly affecting quality of life and often leading to untimely death.

About CUE-101CUE-101 is Cue Biopharma’s lead clinical drug candidate from the CUE-100 series of interleukin 2 (IL-2)-based biologics. It is designed to activate and expand HPV16 tumor-specific T cells by presenting two signals or “cues” to T cells. Signal #1 incorporates the HPV E7 protein, harbored by HPV-induced cancer cells, to provide selectivity through interaction with the HPV-specific T cell receptor. Signal #2 consists of an engineered IL-2 variant to stimulate the activity of T cells. To date, Cue Biopharma has established initial proof of concept with CUE-101 as a monotherapy and believes that the CUE-100 series has the potential to treat multiple cancer indications. CUE-101 is currently being evaluated for the treatment of HPV16+ driven R/M HNSCC as a monotherapy and in combination with pembrolizumab (KEYTRUDA®).

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