Cue Biopharma, Inc. (NASDAQ: CUE)

Cue Biopharma, Inc., a clinical-stage biopharmaceutical company, is at the forefront of engineering a novel class of injectable therapeutics that selectively engage and modulate targeted, disease-relevant T cells directly within the patient's body. The company's unique Immuno-STAT platform emulates the natural process of T cell activation and modulation, allowing for the selective activation and expansion of tumor-specific T cells while avoiding the activation of non-target T cells.

Cue Biopharma's primary products are its Immuno-STAT drug product candidates, which are being developed to treat various types of cancer and autoimmune diseases. The company's most advanced clinical-stage asset is CUE-101, a Phase 1 clinical trial investigating its use in the treatment of human papillomavirus-positive (HPV+) head and neck squamous cell carcinoma (HNSCC) in patients compatible with the human leukocyte antigen (HLA)-A02. Additionally, the company has completed enrollment of its Phase 1b trial of CUE-101 in combination with Merck Sharp & Dohme Corp.'s anti-PD-1 therapy, KEYTRUDA, in patients with recurrent metastatic (R/M) HPV+ HNSCC.

The Immuno-STAT platform is based on a proprietary protein engineering technology that allows for the selective targeting of disease-specific T cells. This approach is designed to provide a therapeutic index for immune activation signals, such as IL-2, by selectively targeting disease-relevant T cells over the vast majority of tumor-irrelevant T cells. This is expected to provide a more targeted and effective treatment for cancer and autoimmune diseases.

Cue Biopharma's competitive advantages include its proprietary Immuno-STAT platform, which allows for the selective targeting of disease-specific T cells. This ability to modulate the immune system in a more targeted and effective manner sets the company apart from its competitors. Furthermore, the Immuno-STAT platform is designed to provide a therapeutic index for immune activation signals, such as IL-2, which is expected to reduce the risk of toxicity and improve the overall safety and efficacy of its drug product candidates.

The company's customers are primarily pharmaceutical companies and research institutions that are interested in developing and commercializing its Immuno-STAT drug product candidates. Cue Biopharma has a strategic collaboration and option agreement with Ono Pharmaceutical Co., Ltd. to further advance CUE-401 for the treatment of autoimmune and inflammatory diseases.

In terms of its business strategy, Cue Biopharma is focused on providing patients suffering from cancer and autoimmune disease with dramatically improved therapeutic outcomes through its platform of biologic drug product candidates. The company is advancing its Tumor Antigen-specific IL-2-based CUE-100 series for oncology, and is seeking strategic partnerships and collaborations for its programs outside of oncology.

Cue Biopharma's intellectual property portfolio includes 94 issued patents and 268 pending patent applications, which describe certain features of its technologies, including its Immuno-STAT platform, CAR-T and ex-vivo applications of its Immuno-STAT platform, and its RDI-STAT platform.

References:
Cue Biopharma, Inc. (2021). SEC Filing. Retrieved from <https://sec.report/Document/0001193125-21-163855/>