Cue Biopharma, Inc. Presents Positive Data Update from Ongoing Phase 1 Trials of Cue-101 for Recurrent/Metastatichpv+ Head and Neck Squamous Cell Carcinoma At the 2023 American Society of Clinical Oncology Annual Meeting
May 25, 2023 at 05:00 pm EDT
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Cue Biopharma, Inc. announced the presentation of a positive data update from its ongoing Phase 1 clinical trials evaluating its lead biologic from the IL-2-based CUE-100 series, CUE-101, for the treatment of patients with human papilloma virus (HPV16+) recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) as a monotherapy and in combination with pembrolizumab. Key data highlights from the Phase 1b trial in combination with pembrolIZumab at the RP2D of 4mg/kg, with 14 evaluable patients as of the data cutoff date of May 15, 2023 include: Overall response rate of 40% with 4 out of 5 confirmed PRs occurring in tumors with low PD-L1 expression as influenced by combined positive scores (CPS) of 20 or less; Importantly, all 5 patients with a confirmed PR demonstrated >99% reduction in circulating cell-free HPV DNA (HPV cfDNA); Median duration of response is 35 weeks with a median progression free survival (PFS) approaching 5 months. Key data highlights from the phase 1b CUE-101 monotherapy patient expansion portion of the trial at the RP2D of4mg/kg to date, include: Current mOS approaching 14 months compares favorably to the historical mOS of 7.5 and 8.4 months reported from third-party clinical trials with checkpoint inhibitors in 2L R/M HNSCC in CheckMate 1411 and KEYNOTE-040 respectively; CUE-101 has been well tolerated to date as monotherapy and in combination with Pembrolizumab; Durable PR greater than 9 months and 6 DSD including a patient remaining on therapy for 2 years, resulting in an overall clinical benefit rate of 35%.
Cue Biopharma, Inc. is a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively modulate disease-specific T cells. The Company's platform, Immuno-STAT (Selective Targeting and Alteration of T cells) and biologics are designed to harness the curative potential of the body's intrinsic immune system through the selective modulation of disease-specific T cells without the adverse effects of broad systemic immune modulation. Its two oncology drug product candidates, CUE-101 and CUE-102, are exemplary programs from the interleukin 2 (IL-2) based CUE-100 series, and are representative of the HLA-A02 allele, which is prevalent in the United States and western European territories. CUE-101 HLA-A02 is engineered for the treatment of human papillomavirus positive, head and neck squamous cell carcinoma (HNSCC). CUE-102 HLA-A02, targeting Wilms' Tumor 1 protein, an oncofetal antigen known to be over-expressed in more than 20 different cancers.
Cue Biopharma, Inc. Presents Positive Data Update from Ongoing Phase 1 Trials of Cue-101 for Recurrent/Metastatichpv+ Head and Neck Squamous Cell Carcinoma At the 2023 American Society of Clinical Oncology Annual Meeting
CUE BIOPHARMA, INC. 
