Tel Aviv Sourasky Medical Center Successfully Completes Phase 1 Study: 29 out of 30 Moderate-to-Severe COVID-19 Patients Recover in 3 to 5 Days thanks to EXO-CD24

Tel Aviv Sourasky Medical Center Successfully Completes Phase 1 Study 29 out of 30 Moderate-to-Severe COVID-19 Patients Recover in 3 to 5 Days thanks to EXO-CD24 TrialsiteN

A novel cancer drug known as EXO-CD24 developed and tested at Tel Aviv Sourasky Medical Center (Ichilov Hospital), demonstrates promising results. Led by Professor Nadir Arber the study was the result of “out-of-the-box thinking” that led to an overwhelmingly positive outcome for this investigational product. The researchers here shared last week that 29 out of 30 patients with moderate-to-severe COVID-19 that participated in this study involving the study drug EXO-CD24 recovered within three to five days. This early-stage Phase 1 safety trial investigating EXO-CD24 has created a buzz in Israel research circles, and beyond as the Prime Minister paid the investigators a visit.

Led by Dr. Nadir Arber of the Integrated Cancer Prevention Center at Tel Aviv Sourasky Medical Center (Ichilov Hospital), this drug was first studied in ovarian cancer.  The therapy, inhaled once daily for five days, was originally developed to treat cancer by regulating the immune system responses.

The Drug

Known as EXO-CD24, this is an exosomes based therapy. According to Dr. Shiran Shapira, director of the lab here, this drug “…is based on exosomes that the body is releasing from the cell membrane and uses for intercellular communication. We enrich the exosomes with the 24CD protein, which is known to play an important role in regulating the immune system.” Shapira has been investigating CD24 protein now for many years.

So essentially the Israeli researchers utilize exosomes, these tiny carrier sac-like features that move materials between cells in a mission to transport CD24 to the lungs. The CD24 protein reports Shapira who works in Dr. Arber’s lab, is situated on the surface cells and is known to have a role in regulating the human immune system. For a nice methodical breakdown, check out YouTube’s Whiteboard Doctor

Put another way, the novel biologic therapeutic agent is based on exosomes carrying CD24. That exosomes overexpressing CD24, put through a process that isolates and purifies them from TRex™-293 cells engineered to express CD24 at high levels, actually serve to suppress the cytokine storm. They are delivered directly to the specific organ based on the utility of exosomes “as a highly body-compatible delivery vehicle.” This approach is followed as it helps support a significant reduction of the necessary dose, therefore reducing risk of adverse events.

The Study

This Phase 1 clinical trial (NCT04747574) sponsored by Tel Aviv Sourasky Medical Center sought to investigate the safety and efficacy of CD24, the small, heavily glycosylated GPI-anchored protein. A key player in the majority of human cancers, but also an important role in controlling the homeostatic proliferation of T-cells, the protein can inhibit inflammation.

As this was a Phase 1 study the number one endpoint was safety—that is, monitoring for adverse events over a 35 day period. The study included ten (10) secondary outcome measures.

Big Meeting

The breakthrough early state trial results generated some attention in this nation in high places. Recently, not only did the Ichilov CEO Ronni Gamzu but also Israeli Prime Minister Benjamin Netanyahu. At the meeting, researchers presented their findings.

Lead Research/Investigator

Professor Nadir Arber, Director Integrated Cancer Protection Center, Tel-Aviv Sourasky Medical Center

Call to Action:  TrialSite will continue to monitor EXO-CD24. Data is still necessary for review—ultimately peer review. Sign up for the newsletter to get daily info.