Cue Biopharma Announces First Patient Dosed in Part B Patient Expansion of CUE-101 Phase 1 Monotherapy Trial in HPV+ Second Line & Beyond HNSCC

Cue Biopharma, Inc. recently announced 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, MD, 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.”

The trial (NCT03978689) is a multi-center, first-in-human, open-label Phase 1 dose escalation and expansion study evaluating the safety, anti-tumor effect and immunogenicity of CUE-101 as a monotherapy in second-line patients with confirmed HPV16-driven recurrent/metastatic HNSCC and HLA-A*02:01 serotype. Based on translational data from the Phase 1a portion of the trial, a recommended Phase 2 dose has been determined. The company has expanded the study to evaluate CUE-101 in combination with KEYTRUDA (pembrolizumab) as first-line treatment in patients with HPV16-driven recurrent/metastatic HNSCC.

The CUE-100 series consists of Fc-fusion biologics that incorporate peptide-MHC (pMHC) molecules along with rationally engineered IL-2 molecules. This singular biologic is anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells directly in the patient. The binding affinity of IL-2 for its receptor has been deliberately attenuated to achieve preferential selective activation of tumor-specific effector T cells while reducing the potential for effects on regulatory T cells (Tregs) or broad systemic activation, potentially mitigating the dose-limiting toxicities associated with current IL-2-based therapies.

The company’s Immuno-STAT (Selective Targeting and Alteration of T cells) biologics are designed for targeted modulation of disease-associated T cells in the areas of immuno-oncology and autoimmune disease. Each of our biologic drugs is designed using our proprietary scaffold comprising: 1) a pMHC to provide selectivity through interaction with the T cell receptor (TCR), and 2) a unique co-stimulatory signaling molecule to modulate the activity of the target T cells.

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.

Cue Biopharma, a clinical-stage biopharmaceutical company, is engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells directly within the patient’s body to transform the treatment of cancer, infectious disease and autoimmune disease. The company’s proprietary Immuno-STAT (Selective Targeting and Alteration of T cells) platform, is designed to harness the body’s intrinsic immune system without the need for ex vivo manipulation.
Headquartered in Cambridge, MA, the company is led by an experienced management team and independent Board of Directors with deep expertise in immunology and immuno-oncology as well as the design and clinical development of protein biologics. For more information, visit