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.
Mode of action
Synthetic alpha-Gal immunotherapy
Stage of development
Clinical studies initiation in 2018
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 as a monotherapy in unresectable metastatic solid tumors. The multi-center, open label study was carried out in the UK, Spain, Israel and the US. In December 2022, the company reported that the study met its primary endpoint for safety and tolerability. Secondary endpoint findings related to immune response and markers of clinical efficacy were also reported. The company plans to seek publication of the trial data at a medical congress in 2023, and in consultation with its scientific advisory board, will determine next steps for the program in the first half of 2023.
- ACIR, 2020
- Galili, OncoIimmun, 2013
- Abdel-Motal, Cancer Immuno Immunother, 2009
- Galili, J Immunol, 2007
December 20, 2022
BioLineRx Announces Results from Phase 1/2a Study of Investigational Anti-Tumor Vaccine AGI-134 in Metastatic Solid Tumors