Cue Biopharma Announces First Patient Dosed in Part B Patient Expansion of CUE-101 Phase 1 Monotherapy Trial in HPV+ Second Line and Beyond HNSCC
CAMBRIDGE, Mass., June 10, 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 directly within the patient’s body, announced today that it has dosed the first patient in the Part B expansion phase of its Phase 1 monotherapy clinical trial of CUE-101 at the recommended Phase 2 dose of 4mg/kg.
The Phase 1b portion of the CUE-101 monotherapy clinical trial in patients with HPV+ second line and beyond (2L+) head and neck squamous cell carcinoma (HNSCC) is expected to enroll up to 20 patients. The data supporting the patient expansion has been encouraging to date, with six patients having confirmed stable disease (SD) and one patient with a confirmed partial response of approximately 50% tumor reduction in the dose escalation Phase 1a portion of the CUE-101 monotherapy trial.
“We are very pleased to have initiated the Part B patient expansion of the CUE-101 monotherapy trial,” stated Ken Pienta, M.D., acting chief medical officer of Cue Biopharma. “We believe the data supporting the selection of the cohort 6 dose at 4mg/kg to confirm a recommended Phase 2 dose gives us growing confidence that CUE-101 may provide a potential path forward for a registration-directed clinical trial as a single agent treatment for HPV+ 2L+ HNSCC.”
About the CUE-101 Clinical Trial
About the CUE-100 Series
The simultaneous engagement of co-regulatory molecules and pMHC binding mimics the signals delivered by antigen presenting cells (APCs) to T cells during a natural immune response. This design enables Immuno-STAT biologics to engage with the T cell population of interest, resulting in selective T cell modulation. Because our drug candidates are delivered directly in the patient’s body (in vivo), they are fundamentally different from other T cell therapeutic approaches that require the patients’ T cells to be extracted, modified outside the body (ex vivo), and reinfused.
About Cue Biopharma
For more information, visit https://www.cuebiopharma.com and follow us on Twitter at https://twitter.com/CueBiopharma.
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