ABX196, a first-in-class iNKT agonist boosting the immune response in cancer

ABIVAX is currently developing ABX196, a state of the art immune enhancer candidate based on iNKT activation. This product is largely derived from the technology and exclusive patent rights transferred to ABIVAX by the Scripps Research Institute (La Jolla, CA), the University of Chicago (Chicago, IL) and the Brigham Young University (Salt Lake City, UT)

A phase I clinical trial in healthy volunteers has been completed and showed activation of iNKT cells. Based on these data, new immuno-oncology pre-clinical studies were conducted that demonstrated the potential of the product in oncology, in particular in turning tumors not responsive to anti-PD-1 (cold) to tumors responsive to anti-PD-1 (hot). As ABIVAX is focusing on the antiviral and anti-inflammatory therapeutic spaces and does not intend to play a role in the immune-oncology field, ABIVAX is seeking to out-license this interesting product candidate.

The characteristics of ABX196 are as follows:

  • ABX196 has been developed from a platform technology proprietary to ABIVAX that identifies “iNKT Agonists” that demonstrate immune enhancing effects in cancer models
  • ABX196 is a synthetic agonist (glycolipid) of iNKT (invariant Natural Killer T) cells, in a liposomal formulation
  • ABX196 is well characterized, with stability studies and full toxicity package (including non-human primate studies) conducted prior to the phase I clinical trial in healthy volunteers
  • Phase I showed ABX196 is well tolerated and triggered both humoral as well as iNKT immune responses in human volunteers
  • Pre-clinical data show that ABX196 enhances anti-tumoral activity when used alone and in combination with anti-PD-1 antibody, doxorubicin or sorafenib
    • ABX196 turns a cold (i.e. non-responding to anti-PD-1 antibody) tumor into a hot, responsive tumor in the mouse melanoma model, corresponding to an increase in survival time
    • ABX196 potentiates the anti-tumoral response to chemotherapy (doxorubicin) in the mouse melanoma model, corresponding to an increase in survival time
    • ABX196 controls tumor progression in an orthotopic hepatocellular cancer model in mice, again showing a prolongation of survival
    • In total, POC of anti-tumoral activities has been established in four preclinical cancer models
  • Easy-to-use liposome formulation, with scaled-up and controlled manufacturing
  • Strong IP protection and FTO: 5 patent families

Cancer, a growing burden

According to the World Cancer Research Fund International, there were an estimated 14.1 million cancer cases around the world in 2012, of these 7.4 million cases were in men and 6.7 million in women. This number is expected to increase to 24 million by 2035. This growing cancer burden, within the overall context of non-communicable diseases (NCDs), was a key focus of the September 2011 UN High Level Meeting on NCDs.

Source: http://www.wcrf.org/int/cancer-facts-figures/worldwide-data

Immune enhancers

Immune enhancers are used to enhance and modulate the immunogenicity of antigens.