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Cue Biopharma Granted U.S. Patents on Lead Clinical Program Novel Drug Product Candidate CUE-101

Patents Further Strengthen and Enhance Intellectual Property (IP) Portfolio CAMBRIDGE, Mass., Sept. 21, 2021 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (NASDAQ:

articleCue Biopharma, Inc.September 21, 20214/company/cue-biopharma/news/cue-biopharma-granted-us-patents-on-lead-clinical-program-novel-drug-product-candidate-cue-101
Cue Biopharma Granted U.S. Patents on Lead Clinical Program Novel Drug Product Candidate CUE-101

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[{"type":"text","content":"Patents Further Strengthen and Enhance Intellectual Property (IP) Portfolio\nCAMBRIDGE, Mass., Sept. 21, 2021 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (NASDAQ: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells directly within the body, announced today the issuance of two new United States Patents Nos. 11,117,945 and 11,104,712 from the United States Patent and Trademark Office. U.S. Patent No. 11,117,945 covers Cue Biopharma’s first clinical drug candidate, CUE-101, and its use in treating HPV16-associated cancers such as head and neck, cervical, and genitoanal cancers. CUE-101 is currently in a Phase 1b clinical trial in which second line and beyond patients are receiving CUE-101 as a monotherapy for HPV16+ recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). To date, CUE-101 has demonstrated monotherapy clinical activity by selective activation of targeted CD8+ T cells specific for HPV+ cancer cells with a 40% clinical benefit in the first 10 evaluable patients at the recommended Phase 2 dose of 4mg/kg. CUE-101 is also in a dose escalation study in combination with pembrolizumab in front-line patients with HPV16+ recurrent/metastatic HNSCC. A Phase 2 exploratory clinical trial in which CUE-101 will be administered in the neoadjuvant phase before standard of care (SOC) therapy in treatment-naïve, HLA-A*0201 positive patients with locally advanced, HPV-positive oropharyngeal squamous-cell carcinoma, is expected to begin enrolling patients this fall. The second U.S. Patent, No. 11,104,712, covers the use of CUE-101 in combination with KEYTRUDA® (pembrolizumab) for treating HPV16-associated cancers such as head and neck, cervical, and genitoanal cancers. The combination of CUE-101 and pembrolizumab is being evaluated by Cue Biopharma in collaboration with Merck Sharp & Dohme Corp. “The issuance of these patents represents an important development as we continue to build-up our IP portfolio and bolster patent protection for the novel protein engineering platforms we have enabled, particularly as we begin demonstrating clinical activity in what we believe will be a disruptive and transformational breakthrough in immunotherapy for addressing cancer and other debilitating and life-threatening diseases,” said Daniel Passer...

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