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Cue Biopharma Announces Clinical Trial Collaboration Agreement with Merck to Evaluate CUE-101 in Combination with KEYTRUDA® (pembrolizumab) as First-line Treatment For HPV+ Recurrent/Metastatic Head and Neck Cancer
- Ongoing Phase 1 dose escalation and expansion study with CUE-101 as a monotherapy in post first-line recurrent/metastatic HNSCC patients to be amended to
About this update from Cue Biopharma, Inc.
[{"type":"text","content":"- Ongoing Phase 1 dose escalation and expansion study with CUE-101 as a monotherapy in post first-line recurrent/metastatic HNSCC patients to be amended to include combination of CUE-101 with standard of care KEYTRUDA as first-line therapy- Preliminary data from early patient cohorts in the current ongoing CUE-101 monotherapy Phase 1 trial in post first-line recurrent/metastatic HNSCC patients demonstrates tolerability and drug exposure, and provides confidence for drug activity consistent with projections based on preclinical data - Recent publication in Clinical Cancer Research includes supporting preclinical data for CUE-101 demonstrating anti-tumor efficacy as monotherapy and in combination with anti-PD-1 treatment\n CAMBRIDGE, Mass., April 20, 2020 (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 within the body, announced today it has entered into a clinical collaboration agreement with Merck (known as MSD outside the United States and Canada), through a subsidiary, to evaluate the combination of Cue Biopharma’s investigational product candidate CUE-101, a first-in-class biologic, with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with advanced head and neck cancer. Collaboration with MerckUnder the terms of the agreement, Cue Biopharma will conduct a Phase 1 study, KEYNOTE-A78, evaluating CUE-101 in combination with KEYTRUDA in first-line HPV+ advanced head and neck cancer. KEYNOTE-A78 will be conducted in parallel with the ongoing Phase 1 monotherapy study of CUE-101 post first-line treatment. The early monotherapy PK data from the first two dosing cohorts demonstrates dose-related drug exposure consistent with preclinical modeling. Subsequent to the respective dose escalations, expansion cohorts evaluating CUE-101 as a monotherapy and in combination with KEYTRUDA will be conducted at optimized dosing regimens. “We are very pleased to collaborate in this important study with Merck, an established leader in cancer immunotherapy, with our first clinical asset, CUE-101, which represents our IL-2 variant CUE-100 Series,” said Daniel Passeri, chief executive officer of Cue Biopharma. “Through the monotherapy and combination studies, we believe we will be able...