Technology

EXO-CD24

The new generation of immunomodulators, better than steroids

Our approach

EXO-CD24 is the next generation of immunomodulators, offering a better, safer and smarter alternative to steroids and other immunomodulators. This precision nanotechnology is designed to target the cytokine storm, the main complication in a wide range of pulmonary and systemic diseases. EXO-CD24 combines two groundbreaking technologies: exosomes (the carriers) engineered to overexpress CD24 (the drug), a novel innate checkpoint protein.

Administration by Inhalation is a significant clinical advantage: it is simple, non-invasive and does not require any professional medical team

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 immune responses, the main cause of side effects.

EXO-CD24 safety and promising efficacy were confirmed in-vitro, in-vivo and in humans.

The drug can be given everywhere, by anyone- even by the patient himself

Technological innovation

Mechanism of Action (MOA)

EXO-CD24 is the first-in class technology allowing the immune system to distinguish between self, Damage Associated Molecular Patterns (DAMPs), released from damaged or dying cells, and non-self, Pathogen Associated Molecular Patterns (PAMPs), derived from pathogens like bacteria, parasites and viruses. While CD24 suppresses immune activation triggered by DAMPs, it does not interfere with the immune system's recognition of PAMPs.

CD24 also attenuates NFĸB activation, thereby reducing overall immune activation.

The unique MOA of EXO-CD24 ensures that its therapeutic efficacy is not dependent on factors like viral variants or disease severity, offering a platform to treat a variety of medical conditions.

Clinical data - efficacy without toxicity in >250 ARDS patients with 4Y of follow-up`

EXO-CD24 can treat various indications, with its primary POC use in treating acute respiratory distress syndrome (ARDS).

A Phase Ib/IIa open-label study was conducted in Tel-Aviv Medical Center (Israel), involving 35 participants who received escalating doses of aerosolized EXO-CD24 (ranging from 1x10⁸ to 1x10¹⁰ particles). Phase IIb study was a multi-center, single-blind, dose-finding trial conducted at three medical centers in Athens (Greece). This study confirmed EXO-CD24's high safety profile and promising efficacy of the drug. EXO-CD24 was also given to 15 severely ill ARDS patients who did not meet the inclusion and exclusion criteria. The Phase IIb trial (NCT05947747), a randomized, double-blind, placebo-controlled study in patients with mild-to-moderate ARDS, has been completed and met its primary endpoint. Results were presented as a late-breaking abstract at CHEST 2026 on October 20, 2026.

Long-term follow-up

In long-term follow-up of an earlier study in patients with COVID-19 (J Extracell Vesicles, 2026), patients treated with EXO-CD24 reported significantly better quality of life. Over 4.6 years of follow-up, none of the 35 EXO-CD24-treated patients died, compared with 13.3% of 105 matched controls. EXO-CD24 is given as a single treatment course. Preclinical work suggests it also supports lung healing after severe infection, which may explain the lasting benefit and points to future indications such as sepsis, delirium and myocardial infarction.

Toward Phase III

Nano24 has submitted its Phase III plan to the FDA and EMA. About 30 leading academic medical centers across Israel, the US, Europe, Asia and Africa have expressed their intention to take part, alongside established industry partners in manufacturing, drug delivery, biomarkers and clinical operations. The trial is designed to support registration in all major markets.

So far, over 250 ARDS patients have been treated with EXO-CD24 as part of clinical trials. The safety profile is exceptional, no serious adverse events (SAEs) or even adverse events (AEs) related to the drug, have been reported along with more than 4 years of follow-up and highly promising clinical and laboratory efficacy.

Beyond respiratory diseases, EXO-CD24 has potential as a treatment for a wide range of systemic diseases by suppressing inflammation. These include autoimmune conditions like rheumatoid arthritis, multiple sclerosis, and graft-versus-host disease, among others. There is a significant and critical need for therapies to address severe cases of these diseases, to prevent long-term hospitalization, the need for ventilation, and death.

Preclinical evidence

EXO-CD24 has shown efficacy across a broad range of inflammatory disease models. It improves survival, limits tissue damage, and rapidly reduces local and systemic cytokines, while resolving inflammatory cell recruitment without suppressing the immune system.

Efficacy across models

ARDS (LPS-induced): a broad reduction of cytokines and chemokines in blood (serum) and lung fluid (bronchoalveolar lavage), measured by multiplex analysis; less inflammatory infiltrate on histopathology; and a clear dose response.
Pulmonary sepsis: significantly improved survival, faster recruitment of the adaptive immune response, and neutrophil clearance within 48 hours.
Abdominal sepsis: longer survival and significantly lower overall mortality.
Asthma: fewer inflammatory infiltrates and lower cytokines.
COPD: efficacy shown in a murine COPD model.
Pulmonary fibrosis: lower pro-inflammatory cytokines.

Compared with steroids

In the ARDS model, EXO-CD24 resolved hyper-inflammation as effectively as dexamethasone, with equivalent improvement in clinical symptoms and reduction of pro-inflammatory cytokines and chemokines. Dexamethasone pushed immune cell counts in the lungs below normal. EXO-CD24 brought them back to normal levels, without causing immunosuppression.

Safety and pharmacokinetics

Dose toxicity studies confirmed a favorable safety profile. EXO-CD24 cleared within 72 hours, with no effects on the histology of the brain, lungs, heart, liver, kidneys, spleen, thymus or thyroid.

From bench to bedside

These findings have carried over to patients. In the first-in-human study at the height of the COVID-19 pandemic, patients recovered rapidly, all cleared the virus by the end of the study, and no drug-related adverse events were recorded.