Cue Biopharma Announces Completion of Patient Enrollment in Phase 1b Study of CUE-101 in Combination with KEYTRUDA

• Completed enrollment of patient expansion cohort of 20 patients at the RP2D of 4 mg/kg in combination with KEYTRUDA (pembrolizumab) in first line (1L) refractory/metastatic HPV+ Head and Neck Cancer patients
• Data to date from CUE-101 in combination with pembrolizumab demonstrates more than double the historical ORR of pembrolizumab alone, including patients with tumors of low PD-L1 expression
• Updated data from both the combination and monotherapy trials will be presented at the 2023 Society for Immunotherapy of Cancer (SITC) Annual Meeting being held November 1-5
  
  

BOSTON, Sept. 26, 2023 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient’s body, today announced that it has completed patient enrollment in its Phase 1 clinical trial (NCT03978689) evaluating CUE-101, the company’s lead interleukin 2 (IL-2)-based biologic from the CUE-100 series, in combination with KEYTRUDA (pembrolizumab) as first-line treatment for patients with human papilloma virus positive recurrent/metastatic head and neck squamous cell carcinoma (HPV+ R/M HNSCC).

“Completing the enrollment of the recommended phase 2 dose patient expansion cohort is an important milestone as the data from this trial guides further development plans and associated discussions with the Food and Drug Administration (FDA),” said Daniel Passeri, chief executive officer of Cue Biopharma. “We believe the updated data will build upon the already promising clinical profile established to date, which has shown an enhancement of clinical efficacy with the CUE-101-pembrolizumab combination compared to pembrolizumab alone. With the strength of the data already observed with monotherapy in second line patients and beyond, combined with the promising combination data emerging in 1L with pembrolizumab, we plan to discuss potential registrational paths with the Food and Drug Administration (FDA) for CUE-101 both as a monotherapy and in combination with pembrolizumab, leveraging the Fast Track Designation previously granted to these programs.”