Our Approach

Harnessing the Immune System

“Restoration of Immune Balance via Harnessing Nature’s Cues”

Immune balance is essential for sustaining human health while dysregulation and imbalance of the immune system can lead to serious diseases. Susceptibility to cancers and chronic infectious disease can be attributed to inadequate or attenuated immune responses, while autoimmune diseases result from an overactive immune system.

To date, much of the focus has centered on approaches that result in broad and non-specific immune modulation with significant challenges remaining to be addressed regarding efficacy and patient safety. To that end, a superior therapeutic strategy would selectively and specifically modulate disease-relevant T cells while sparing protective immunity, preserving patient safety and immune homeostasis and balance.

To address this therapeutic vision, Cue Biopharma’s breakthrough biologic platform deploys rational protein engineering to design and develop novel proprietary molecules that build upon the fundamental immunological principles that underscore T cell activation. These principles focus on “nature’s cues” for antigen specificity of the T cells, along with appropriate secondary activating or inhibitory signals, dependent on the disease. We believe our novel platform, Immuno-STAT™ (Selective Targeting and Alteration of T cells), provides a superior differentiated solution for tackling complex immune diseases in a selective and specific manner for effective and safe immune therapies.

The Immuno-STAT: A Selective Immune Response, Induced on Cue

Cue Biopharma has engineered a proprietary class of biologics to selectively modulate the activity of antigen-specific T cells in a patient’s body. 

Our biologics are engineered to direct T cell activity via two distinct signals presented naturally by the body when mounting an immune response.


Core Components

Signal 1: A stabilized peptide-MHC complex (pMHC) to engage disease-relevant T cells.

Signal 2: A co-stimulatory or inhibitory signal to control the activity of target T cells.

Fc Backbone: A well-characterized construct that provides stability and ease of manufacture.

Therapeutic Application of Immuno-STATs

Cue Biopharma is actively exploring the therapeutic potential of Immuno-STATs to treat cancer, chronic infectious diseases, and autoimmune diseases. 

  • In the context of cancer and chronic infectious disease, Immuno-STATs are designed to selectively activate disease-specific T cells.
  • For the treatment of autoimmune disease, Immuno-STATs are designed to selectively inhibit pathogenic autoreactive T cells.

Our lead compound, CUE-101, is designed to specifically engage and activate T cells in the body to target HPV-driven cancers. A dose-escalation and expansion Phase 1 clinical trial of CUE-101 in patients with HPV-driven head and neck cancer commenced in September 2019 (NCT03978689).

Commercialization Advantages

In addition to the selective control of T cell activity, we believe Immuno-STATs offer several key points of potential differentiation over competing approaches:

  • Broad Disease Coverage – Access to a growing set of disease targets (extracellular and intracellular antigens) and patient populations (diverse HLA types).
  • Manufacturable – Utilizes industry standard development and production process to support a cost-of-goods and supply chain similar to monoclonal antibodies.
  • Conveniently Administered – Standard delivery format (IV, SubQ) over a dosing schedule (weekly, monthly) that can be administered by specialists and community-based physicians.