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Cue Biopharma Initiates Patient Dosing in Phase 1 Study of CUE-101 in Combination with KEYTRUDA® (pembrolizumab) as First-line Treatment for HPV+ Recurrent/Metastatic Head and Neck Cancer
CAMBRIDGE, Mass., Feb. 08, 2021 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of
About this update from Cue Biopharma, Inc.
[{"type":"text","content":"CAMBRIDGE, Mass., Feb. 08, 2021 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics designed to selectively engage and modulate targeted T cells within the patient’s body, announced today that on February 1, 2021, the first patient was dosed in a Phase 1 dose escalation clinical trial of CUE-101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab). CUE-101 is being evaluated in combination with KEYTRUDA® as first-line treatment for human papilloma virus positive recurrent/metastatic head and neck squamous cell carcinoma (HPV+ R/M HNSCC). “We are very pleased to have initiated our combination trial of CUE-101 with KEYTRUDA,” said Ken Pienta, M.D, acting chief medical officer of Cue Biopharma. “In our ongoing dose escalation monotherapy Phase 1 trial, CUE-101 has been well tolerated at doses where we’ve observed preliminary evidence of clinical activity, and in preclinical studies we’ve demonstrated that the combination of CUE-101 and checkpoint blockade appear synergistic by significantly extending survival in mouse models of HPV positive cancers. These data taken together support our belief that the combination of CUE-101 with KEYTRUDA has the potential to enhance anti-tumor activity and prolong patient survival.” This Phase 1 dose escalation combination trial (NCT03978689) is being conducted in parallel at the same clinics that are conducting the ongoing Phase 1 monotherapy study of CUE-101. Due to the tolerability profile demonstrated to date in the CUE-101 monotherapy dose escalation trial, the first dose in the combination arm is 1 mg/kg every three weeks (Q3W), which is also the recommended dosing interval for KEYTRUDA. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. About the CUE-100 SeriesThe CUE-100 series consists of Fc-fusion biologics that incorporate peptide-MHC (pMHC) molecules along with rationally engineered IL-2 molecules. This singular biologic is anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells directly in the patient. The binding affinity of IL-2 for its receptor has been deliberately attenuated to achieve preferential selective activation of tumor-specific effector T cell...