The safety and efficacy of the following investigational drug has not been established. This use has not been approved by the U.S. Food and Drug Administration or other regulatory authorities.

AGI-134 is a novel cancer immunotherapy in development to treat solid tumors. This synthetic alpha-Gal glycolipid is injected intratumorally and coats tumor cells. Pre-existing alpha-Gal antibodies bind the alpha-Gal-coated tumor cells and trigger several innate and adaptive immune response cascades against the tumor.

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How AGI-134 Works

AGI-134 is designed to label cancer cells with alpha-Gal, tagging them as foreign tissue to evoke an immune response against patient’s tumors. Binding of pre-existing anti-Gal antibodies to the alpha-Gal-coated tumors activates innate immune system elements, such as complement and antibody-mediated cellular cytotoxicity, which destroy the cancer cells. This local tumor cell death promotes a proinflammatory tumor microenvironment, releases tumor antigens to be presented to T cells by antigen presenting cells (APC), and induces a systemic, specific anti-tumoral immune response and memory.

Solid tumors
Scientific illustration depicting how AGI-134 works in solid tumors
Scientific illustration depicting how AGI-134 works in solid tumors

Solid tumorsAGI-134

AGI-134 successfully completed a first-in-human, Phase 1/2, open-label study as a monotherapy in unresectable and metastatic solid tumors. The clinical trial met its primary endpoints of safety and tolerability. Most patients analyzed showed an increase in alpha-Gal antibodies, indicating increased overall immune activity. Additionally, increases in antigen-presenting cells (APCs) were observed in most tissue samples analyzed. Radiological assessments found that 29 percent of patients in the trial achieved best overall response of stable disease, including patients who had previously failed checkpoint-inhibitor therapy.

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