EXO-CD24
The new generation of immunomodulators, better than steroids
EXO-CD24
The new generation of immunomodulators, better than steroids.
EXO-CD24
The new generation of immunomodulators, better than steroids.
Our approach
EXO-CD24, The new generation of immunomodulators, better than steroids. It is a new precision nanotechnology aimed to target the most important complication of a wide spectrum of pulmonary and systemic diseases, the cytokine storm.
Two breakthrough technologies are combined in EXO-CD24; exosomes (the carriers) engineered to over-express CD24 (the drug), a novel innate checkpoint protein.
Exosomes:
advanced therapy, a promising and relatively new therapeutic area. The exosomes are nano-sized lipid vesicles secreted by most cell types, normal and diseased, and transmit information to other cells via delivery of biologically active cargo.
CD24:
a small, heavily-glycosylated glycosylphosphatidylinositol (GPI)-anchored protein that, among other things, functions as a cell adhesion molecule, an immune checkpoint, and a biological immunomodulator.
Exosomes
advanced therapy, a promising and relatively new therapeutic area. The exosomes are nano-sized lipid vesicles secreted by most cell types, normal and diseased, and transmit information to other cells via delivery of biologically active cargo.
CD24
a small, heavily-glycosylated glycosylphosphatidylinositol (GPI)-anchored protein that, among other things, functions as a cell adhesion molecule, an immune checkpoint, and a biological immunomodulator.
EXO-CD24 is administered by inhalation directly into the lungs to suppress the inflammatory response to tissue injuries. The potential efficacy stems from using an endogenous immunomodulator of the immune system (CD24). Safety has been secured by using natural exosomes, promising endogenous drug carriers, hence they do not trigger side effects.
EXO-CD24 safety and promising efficacy were confirmed in-vitro, in-vivo and in humans.
Technological innovation
Mechanism of action
EXO-CD24 allows immune discrimination between Damage Associated Molecular Patterns (DAMPs), released from damaged or dying cells, and Pathogen Associated Molecular Patterns (PAMPs) derived from pathogens such as bacteria and viruses. While CD24 suppresses DAMPs-initiated immune activation, it does not affect PAMPs-immune recognition.
CD24 attenuates NFĸB activation and therefore immune activation.
The MOA of EXO-CD24 eliminates the therapeutic efficacy's dependence on parameters such as viral variants and severity of the diseases and provides treatment for several airways-related conditions.
Mechanism of Action:
EXO-CD24 allows immune discrimination between Damage Associated Molecular Patterns (DAMPs), released from damaged or dying cells, and Pathogen Associated Molecular Patterns (PAMPs) derived from pathogens such as bacteria and viruses. While CD24 suppresses DAMPs-initiated immune activation, it does not affect PAMPs-immune recognition.
CD24 attenuates NFĸB activation and therefore immune activation.
The MOA of EXO-CD24 eliminates the therapeutic efficacy's dependence on parameters such as viral variants and severity of the diseases and provides treatment for several airways-related conditions.
Clinical data - efficacy without toxicity
EXO-CD24 can be used for various indications, the primary indication being moderate/severe COVID-19 patients as a proof of concept for the treatment of Acute Respiratory Distress Syndrome (ARDS).
A Phase Ib/IIa was conducted in Israel. It was an open-label study that included 35 participants that were given increasing doses (from 1x108 to 1x1010 aerosolized EXO-CD24 particles).
Phase IIb was a multi-center single-blind dose-finding study. It was conducted in three medical centers in Athens. These studies confirmed the high safety profile of the drug (without any SAEs/AEs related to the drug), as well as promising efficacy.
The ultimate international, multi-center, quadri-blind phase IIb study, EXO-CD24 Vs placebo, is ongoing in Israel and EU.
On top of the respiratory diseases, EXO-CD24 can serve as the therapy to a plethora of systemic diseases to suppress the inflammatory response. These include autoimmune diseases such as rheumatoid arthritis, multiple sclerosis, and graft-versus-host disease among many others. A clear need exists to treat severe cases of these diseases to prevent long-term hospitalization, ventilation, and death.