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CUE 101

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Drug Profile

CUE 101

Alternative Names: CUE-101; LR-19127

Latest Information Update: 25 Sep 2025

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At a glance

  • Originator Cue Biopharma
  • Developer Cue Biopharma; Merck Sharp & Dohme Corp.
  • Class Antineoplastics; Immunotherapies; Interleukins; Recombinant fusion proteins
  • Mechanism of Action Interleukin 2 replacements; T lymphocyte stimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes
  • Available For Licensing Yes - Squamous cell cancer

Highest Development Phases

  • Phase II Squamous cell cancer

Most Recent Events

  • 15 Sep 2025 Yale University plans a phase II trial in collaboration with Cue Biopharma and National Cancer Institute (NCI) for Squamous cell carcinoma (Neoadjuvant therapy, Late-stage disease, Monotherapy, Combination therapy, Inoperable/Unresectable) in USA (IV infusion) (NCT07172256)
  • 16 Jul 2025 Updated efficacy data from a phase Ib KEYNOTE-A78 trial in Squamous cell cancer released by Cue Biopharma
  • 09 Jul 2025 CUE 101 is still in phase I trials for Squamous cell cancer (Monotherapy, Combination therapy, Metastatic disease, Recurrent, Second-line therapy or greater) in USA (IV) (NCT03978689)

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