Cue Biopharma is pioneering a novel class of immunotherapies designed to selectively activate the immune system against cancer by mimicking natural immune signals, referred to as "Cues." Their primary technology, the Immuno-STAT™ (Selective Targeting and Alteration of T cells) platform, enables the engineering of stable, off-the-shelf biologics that engage tumor-specific T cells through a dual-signal mechanism. The first signal involves presenting tumor-specific proteins via a major histocompatibility peptide complex (pMHC) to T cell receptors, enhancing the specificity of the immune response. The second signal utilizes interleukin-2 (IL-2) to selectively activate these T cells, particularly CD8+ cytotoxic T cells, while minimizing the activation of regulatory T cells, thereby improving the therapeutic window and reducing potential toxicities associated with traditional IL-2 therapies.

In addition to its focus on cancer, the Immuno-STAT platform offers versatility for treating other conditions, including autoimmune and infectious diseases, by modifying the signals presented. This approach eliminates the need for ex vivo manipulation, which is a requirement for other therapies like CAR-T and TCR-T, making it a more streamlined option for patients. The technology's ability to stimulate and activate the adaptive immune response without blocking specific biochemical pathways positions Cue Biopharma's therapies as a promising advancement in the field of immuno-oncology and beyond.

United States

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 body to transform the treatment of cancer 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.

Cancer

Immune System Diseases

Inflammatory disorders

Cue Biopharma

Head and neck cancer

Head and neck squamous cell carcinoma

Human papillomavirus

Solid tumor/s

Our lead drug from the CUE-100 framework, CUE-101, contains IL-2 and a pMHC composed of HLA-A*02:01 complexed with a dominant peptide derived from the human papilloma virus E7 protein (HPV-E7).&nbsp; It is a fusion protein biologic designed to target and activate antigen-specific T cells to fight HPV-driven cancers.
In preclinical studies, CUE-101 has demonstrated selective binding and preferential activation and expansion of antigen-specific T cells, dose-dependent effector cytokine production and inhibition of tumor growth both as a monotherapy and in combination with a PD-1 inhibitor.&nbsp; These findings were previously presented at the&nbsp;<a href="https://cuebiopharma.gcs-web.com/node/6756" rel="noreferrer noopener" target="_blank">Society for Immunotherapy of Cancer’s (SITC) 33rd Annual Meeting</a>.
In September 2019, we commenced our first-in-human, dose-escalation and expansion Phase 1 clinical trial of CUE-101 in patients with HPV-positive relapsed or refractory head and neck squamous cell carcinoma (<a href="https://www.globenewswire.com/Tracker?data=-wv7p8iI31tt0HtOETrdsSVAxAtQw0M-QwpOK28MAkyNv7ZLu3hlmeqb6n-WAwzH5A1qrN45DUEr9aUwfaB4EUm9aZzAUpQwcfYEMIs-NloSvhljB3X1WfzqJiG4lnN1bSK61dCLeSOhFwG4LxzmZhNmaKTW3_TqJ1tVbamriHmgJ2BBTQBkEUD5dgoLRDVyUDFkuwBdB_IV8aA9HBtCYSRtSSrwK0en9RW57_st8jM=" rel="noreferrer noopener" target="_blank">NCT03978689</a>). Cue Biopharma has engaged a network of nationally recognized clinical investigators and 13 Phase 1 sites are actively recruiting patients.
HPV cancers account for more than 20,000 deaths each year in the US and Europe. The majority of these cancers are driven by HPV 16 which carries the E7 antigen 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. &nbsp;Patients with HPV-related head and neck, cervical and genitoanal cancers represent an important unmet clinical need and underscore the opportunity for promising new therapeutics.

Cue Biopharma

Company Details