Cue Biopharma Inc
NASDAQ:CUE
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Cue Biopharma Inc
Cue Biopharma, Inc. is a clinical-stage biopharmaceutical company, which engages in the development of a novel and proprietary class of biologic drugs for the selective modulation of the human immune system to treat a broad range of cancers and autoimmune disorders. The company is headquartered in Cambridge, Massachusetts and currently employs 57 full-time employees. The company went IPO on 2018-01-02. The firm is engineering a class of injectable biologics designed to selectively engage and modulate targeted T cells within the body to treat a range of cancers, chronic infectious diseases, and autoimmune diseases. The company has developed Immuno-STAT (Selective Targeting and Alteration of T Cells) platform, which harness an individual's intrinsic immune repertoire for restoring health while avoiding the deleterious side effects of broad immune activation (for immuno-oncology or infectious disease indications) or broad immune suppression (for autoimmunity and inflammation). The company has developed four biologic series within the Immuno-STAT platform, which includes CUE-100, CUE-200, CUE-300 and CUE-400, each specifically designed through rational protein engineering to possess distinct signaling modules for desired biological mechanisms to be applied across many diseases. CUE-101 is its advanced clinical stage asset.
Cue Biopharma, Inc. is a clinical-stage biopharmaceutical company, which engages in the development of a novel and proprietary class of biologic drugs for the selective modulation of the human immune system to treat a broad range of cancers and autoimmune disorders. The company is headquartered in Cambridge, Massachusetts and currently employs 57 full-time employees. The company went IPO on 2018-01-02. The firm is engineering a class of injectable biologics designed to selectively engage and modulate targeted T cells within the body to treat a range of cancers, chronic infectious diseases, and autoimmune diseases. The company has developed Immuno-STAT (Selective Targeting and Alteration of T Cells) platform, which harness an individual's intrinsic immune repertoire for restoring health while avoiding the deleterious side effects of broad immune activation (for immuno-oncology or infectious disease indications) or broad immune suppression (for autoimmunity and inflammation). The company has developed four biologic series within the Immuno-STAT platform, which includes CUE-100, CUE-200, CUE-300 and CUE-400, each specifically designed through rational protein engineering to possess distinct signaling modules for desired biological mechanisms to be applied across many diseases. CUE-101 is its advanced clinical stage asset.
Clinical Data: CUE-101 continues to show strong and maturing survival benefits in head and neck cancer, especially in combination with pembrolizumab (KEYTRUDA), with a 12-month overall survival of 90% in CPS ≥1 patients.
Program Focus: Company is prioritizing autoimmune pipeline (CUE-401, CUE-501) and delaying capital-intensive registration trials to conserve cash and let clinical data mature.
Strategic Partnerships: Significant progress with ONO Pharmaceuticals on CUE-401 for autoimmune diseases; lead candidate selection expected in Q1 next year, and Cue retains 50% US co-development/co-marketing rights.
Cash Runway: Operational runway extended to mid-2025 and annual cash burn reduced from $40 million to $30 million through restructuring and partnerships.
Partnering Strategy: Actively seeking partnerships for CUE-501 and other pipeline assets to help fund development and reduce dilution; multiple discussions ongoing.
Competitive Position: Management highlights differentiated safety and efficacy profile of Immuno-STAT platform versus CAR-T and pan-T cell engagers, with low immunogenicity and robust manufacturability.
