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Cue Biopharma Presents New Positive Data from Ongoing Phase 1 Trial of CUE-101 in Combination with KEYTRUDA(R) for Recurrent/Metastatic HPV+ Head and Neck Cancer at the Society for Immunotherapy of Cancer’s (SITC) 37th Annual Meeting
Overall response rate (ORR) of 40% and a clinical benefit rate (CBR) of 70% observed to date in first line (1L) recurrent/metastatic HNSCC patients treated

About this update from Cue Biopharma, Inc.
[{"type":"text","content":"Overall response rate (ORR) of 40% and a clinical benefit rate (CBR) of 70% observed to date in first line (1L) recurrent/metastatic HNSCC patients treated with CUE-101 at the recommended Phase 2 dose and pembrolizumab.Median overall survival (mOS) approaching greater than 12 months in third line and beyond (3L+) patients treated to date with CUE-101 monotherapy, which is 50% greater than current standard of care (SOC) with anti-PD-1 therapy in second line (2L) patients.Company on track to define potential registrational CUE-101 monotherapy trial by mid-2023. BOSTON, Nov. 10, 2022 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of injectable biologics to selectively engage and modulate tumor-specific T cells directly within the patient’s body, announced today the presentation of new positive data from its ongoing Phase 1 trial evaluating its lead interleukin 2 (IL-2)-based biologic, CUE-101 in combination with pembrolizumab (KEYTRUDA), as a first line therapy for patients with recurrent/metastatic HPV+ head and neck squamous cell carcinoma (HNSCC). The data will be presented in a poster at the Society for Immunotherapy of Cancer’s 37th Annual Meeting (SITC 2022), to be held in Boston, Massachusetts and virtually on November 8-12, 2022. The poster will also provide an update from the Company’s ongoing fully enrolled Phase 1b trial evaluating CUE-101 monotherapy as third line and beyond therapy in the same patient population. Additionally, the Company will present two posters discussing the design of its ongoing Phase 1 trial evaluating its second IL-2 based candidate, CUE-102, for the treatment of Wilms’ Tumor 1 positive (WT1+) malignancies, and preclinical data regarding its mechanistic effect in vitro and in vivo. “We are very encouraged with the overall response rate observed in the trial so far with CUE-101, and its potential to improve standard of care for HPV+ head and neck cancer patients,” said Dr. Christine Chung, M.D., Chair, Department of Head and Neck-Endocrine Oncology, Moffitt Cancer Center, and a principal investigator participating in the clinical trial. “There is an urgent need for more effective and durable treatment options with less side effects as more than half of all patients with recurrent/metastatic HNSCC given the current standard...