Cue Biopharma, Inc 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 the publication of research demonstrating the ability of its lead biologic candidate CUE-101 to activate tumor antigen specific antitumor immunity in the peer-reviewed medical journal Clinical Cancer Research, a journal of the American Association for Cancer Research. The manuscript by Steven Quayle et al. is titled “CUE-101, a Novel HPV16 E7 pHLA-IL-2-Fc Fusion Protein, Enhances Tumor Antigen Specific T Cell Activation for the Treatment of HPV16-Driven Malignancies.”
The research highlights the ability of the company’s proprietary Immuno-STAT™ (Selective Targeting and Alternation of T cells) platform to selectively engage and modulate targeted T cells within the body. CUE-101 is the company’s lead drug candidate from the IL-2 based CUE-100 series designed to directly engage and activate T cells to target HPV16-driven recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).
The published results show that CUE-101 demonstrated selective binding, activation and expansion of the disease-relevant human T cell population in vitro, as well as predict a favorable safety profile. A murine surrogate molecule (mCUE-101) administered to HPV16 E7 tumor bearing mice resulted in selective expansion of disease-relevant T cells, anti-cancer efficacy and immunologic memory. In addition, mCUE-101 administered as a combination therapy with anti-PD-1 checkpoint inhibition further enhanced anti-tumor efficacy. These data support the potential for CUE-101 to enhance anti-tumor immunity in HPV16-driven malignancies. CUE-101 is currently being studied in a Phase 1 clinical trial (NCT03978689) for HPV16-driven HNSCC. The Phase 1 trial is evaluating the safety and tolerability, anti-tumor response, pharmacokinetics and immunogenicity of CUE-101 as a monotherapy in patients with confirmed HPV16-driven recurrent/metastatic HNSCC and HLA-A*02:01 serotype. Based on results from this trial, including translational pharmacodynamic immunorofiling data, the company may expand the study to test CUE-101 in the neoadjuvant setting and in combination with checkpoint inhibitors in patients with HPV16-driven HNSCC.
“This seminal publication from Cue Biopharma exemplifies the core-strength of our Immuno-STAT biologics platform, in particular the CUE-100 series that incorporates rationally engineered IL-2 molecules for selective activation of tumor-specific T cells. The preclinical and ex vivo human translational data presented in this paper underscore the promising potential for the current, ongoing clinical study evaluating CUE-101 monotherapy in HPV-driven head and neck cancer,” stated Anish Suri, Ph.D., president and chief scientific officer of Cue Biopharma.
HPV-driven cancers account for more than 20,000 deaths each year in the U.S. and Europe. The majority of these cancers are driven by HPV16 which carries the E7 protein targeted by CUE-101. Despite treatment with current standards of care, approximately 50% of patients with advanced disease will experience recurrence and significant quality of life impact. Patients with HPV-driven cancers represent an important unmet clinical need and underscore the opportunity for promising new therapeutics.
Clinical Cancer Research is a peer-reviewed medical journal published by the American Association for Cancer Research (AACR). The journal publishes innovative clinical and translational cancer research studies that bridge the laboratory and the clinic.
