Cue Biopharma Initiates Patient Dosing in Phase 1 Study of CUE-101 in Combination with KEYTRUDAr as First-line Treatment for HPV+ Recurrent/Metastatic Head & Neck Cancer

Cue Biopharma, Inc. recently announced the first patient was dosed in a Phase 1 dose escalation clinical trial of CUE-101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab). CUE-101 is being evaluated in combination with KEYTRUDA as first-line treatment for human papilloma virus positive recurrent/metastatic head and neck squamous cell carcinoma (HPV+ R/M HNSCC).

“We are very pleased to have initiated our combination trial of CUE-101 with KEYTRUDA,” said Ken Pienta, MD, Acting Chief Medical Officer of Cue Biopharma. “In our ongoing dose-escalation monotherapy Phase 1 trial, CUE-101 has been well tolerated at doses where we’ve observed preliminary evidence of clinical activity, and in preclinical studies we’ve demonstrated that the combination of CUE-101 and checkpoint blockade appear synergistic by significantly extending survival in mouse models of HPV positive cancers. These data taken together support our belief that the combination of CUE-101 with KEYTRUDA has the potential to enhance anti-tumor activity and prolong patient survival.”

This Phase 1 dose escalation combination trial (NCT03978689) is being conducted in parallel at the same clinics that are conducting the ongoing Phase 1 monotherapy study of CUE-101. Due to the tolerability profile demonstrated to date in the CUE-101 monotherapy dose-escalation trial, the first dose in the combination arm is 1 mg/kg every 3 weeks (Q3W), which is also the recommended dosing interval for KEYTRUDA.

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 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 highly targeted 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 within the patient’s body to transform the treatment of cancer, infectious diseases and autoimmune diseases. The company’s proprietary platform, Immuno-STAT (Selective Targeting and Alteration of T cells) is designed to harness the body’s intrinsic immune system without the need for ex vivo manipulation.

Headquartered in Cambridge, MA, we are led by an experienced management team and independent Board of Directors with deep expertise in the design and clinical development of protein biologics, immunology and immuno-oncology. For more information, visit www.cuebiopharma.com.