AGI-134 is a synthetic αGal immunotherapy in development for solid tumors. AGI-134 harnesses the body’s pre-existing, highly abundant, anti-αGal (anti-Gal) antibodies to induce a systemic, specific anti-tumor response to the patient’s own tumor neo-antigens. This response not only kills the tumor cells at the site of injection, but also brings about a durable, follow-on anti-metastatic immune response. αGal is a cell-surface carbohydrate antigen which is not expressed by humans, unlike virtually all other mammals and bacteria. Therefore, humans universally produce and maintain high levels of anti-Gal antibodies, due to exposure to αGal on bacteria in the digestive system.
Mode of action
Synthetic alpha-Gal immunotherapy
Stage of development
Clinical studies initiation in 2018
AGI-134 has completed numerous pre-clinical studies, demonstrating robust protection against the development of secondary tumors in two models of melanoma.
A single dose of AGI-134 conferred a systemic durable response which resulted in long-term protection against the development of secondary tumors for over 90 days. AGI-134 was tested in combination with the well-known immune checkpoint inhibitor anti-PD1 antibody. AGI-134 demonstrated to be synergistic in combination with an anti-PD-1, thus offering the potential to broaden the utility of such immunotherapies, and improve the rate and duration of responses in multiple cancer types.
GLP toxicology study in monkeys with AGI-134 has also been successfully completed.
The use of intra-tumoral αGal glycolipids to treat solid tumors was invented by Prof. Uri Galili, Ph.D., while at the University of Massachusetts, from which the intellectual property rights were licensed. The intellectual property rights relating to AGI-134 were in-licensed from Kode Biotech Ltd., the inventors of AGI-134