AGI-134

AGI-134 is a synthetic alpha-Gal glycolipid in development for solid tumors that is highly differentiated from other cancer immunotherapies. AGI-134 is designed to label cancer cells with alpha-Gal via intra-tumoral administration, thereby targeting the body’s pre-existing, highly abundant anti-alpha-Gal (anti-Gal) antibodies and redirecting them to treated tumors. Binding of anti-Gal antibodies to the treated tumors results in activation of the complement cascade, which destroys the tumor cells and creates a pro-inflammatory tumor microenvironment that also induces a systemic, specific anti-tumor (vaccine) response to the patient’s own tumor neo-antigens.

AGI-134

Therapeutic areas

Therapeutic areas

Solid tumors

Mode of action

Mode of action

Synthetic alpha-Gal immunotherapy

Stage of development

Stage of development

Clinical studies initiation in 2018

Development

AGI-134 has been evaluated in numerous pre-clinical studies. In a mouse melanoma model, treatment with AGI-134 led to regression of established primary tumors and suppression of secondary tumor (metastases) development. Synergy has also been demonstrated in additional pre-clinical studies when combined with an anti-PD-1 immune checkpoint inhibitor, offering the potential to broaden the utility of such immunotherapies, and improve the rate and duration of responses in multiple cancer types. AGI-134 was obtained through the acquisition of Agalimmune Ltd.

In August 2018, we initiated a Phase 1/2a clinical study for AGI-134 that is primarily designed to evaluate the safety and tolerability of AGI-134 given monotherapy in unresectable metastatic solid tumors. The multi-center, open label study is being carried out in the UK, US and Israel. Results from the first part of the study showed that AGI-134 was safe and well tolerated, with no serious drug-related adverse events or dose-limiting toxicities reported. Initial proof of mechanism results from the second part of the study, commenced in September 2019, are expected by the second half of 2021.

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.