High Hopes for Israeli Cell Therapy for Hospitalized COVID-19 Patients, Aiming to Help ‘Live With the Virus’

As vaccine effectiveness has been found to wane over time, an Israeli clinical-stage biotech company is optimistic about the authorization of its experimental cell-based drug therapy to treat pneumonia and respiratory distress suffered by severe COVID-19 patients, hoping to keep them out of hospitals.

“The more vaccinated people we will have the less COVID we will have. Nevertheless, vaccination effectiveness reduces so dramatically after four or five months, even after second vaccination, and the third one is not the end of the story — which allowed us to understand that COVID is not going anywhere,” Shai Meretzki, founder and CEO of Bonus Biogroup told The Algemeiner. “The ability to have a therapy which specifically heals severe COVID-19 patients and gets them out of hospitals is amazing, because it means that we can live with the virus.”

Bonus Biogroup, which focuses on the development of biomedical tissue engineering and cell therapy products, announced this month that it has concluded a Phase II clinical trial to assess the safety and efficacy of its MesenCure therapy in 50 severe COVID-19 patients — who suffer from acute respiratory distress syndrome (ARDS) and other life-threatening lung diseases, and have a mortality rate of 35 percent.

The Haifa, Israel-based company expects to publish results from the trial in November.

Meretzki is hopeful that results from the Phase II trial will be “good enough” to get marketing approval for the therapy from Israeli regulators without the need to conduct a Phase III trial. But he acknowledged that in the US, the Food and Drug Administration (FDA) will demand a late-stage trial.

“We hope we can get emergency approval to take care of everyone globally with a regular treatment as soon as possible to get the majority of severe COVID-19 patients out of hospitals,” Meretzki said.

He described the company’s novel method for growing live, active human tissue outside the human body, which it started tested by growing bone.

“When COVID broke out we understood very quickly that what is killing many severely infected patients is not the virus.  It’s a process called cytokine storm, in which the virus gets into the human cells, the immune system of the patient attacks the infected cells very strongly and blocks the lungs by billions of immune cells,” he explained. “When the lung is filling with immune cells you don’t breathe anymore.”

With that in mind, Bonus Biogroup started to do more research into mesenchymal stromal cells (MSCs), which they use on a day-to-day basis and derive from the patient’s own tissue to create bone tissue. It found that the natural activity of MSCs had anti-inflammatory potential by regulating the overshooting of the immune system.

“We decided to try and use our MSCs to try and relax the overreaction a bit, and as a result patients will be cured as the virus itself doesn’t kill them,” Meretzki said. “We are a year after this point and we have the first product in the world, MesenCure, that has the ability to reduce, not to shut down, the overactivity of the immune system. We have the only therapy for the treatment of hundreds of thousands if not billions of severe COVID-19 patients suffering from life-threatening inflammatory diseases.”

MesenCure is an allogeneic, cell-based experimental drug, consisting of primed mesenchymal cells, which are isolated from the fat tissue of healthy donors. Technologies developed by Bonus BioGroup were used to obtain a higher number of cells from a donor; once isolated, the company enhanced the cells’ therapeutic efficacy.

The drug is administered via injection of mesenchymal cells. After injection into the patient’s body, the cells travel to the inflamed lungs and depress the cytokine storm caused by the coronavirus — which in turn promotes the relief of symptoms and the healing process of the respiratory system and other internal organs. With one sample of cells, 45,000 patients can be treated, according to Meretzki.

The results of the therapy’s early-stage clinical trial conducted earlier this year in 10 severe COVID-19 patients aged 45 to 75 showed “significant” decrease in inflammation of the lungs. The patients were discharged from the hospital within a median of one day following treatment requiring no respiratory support. As a result, the stay of severe COVID-19 patients in the hospital was reduced by an average of 10 days, the company said.

Chest X-rays of the patients demonstrated a reduction in inflammation from about 55% of the lung area before treatment, to about 15%, five days after starting the treatment, and up to around 1%, about a month after treatment initiation.

“The treatment results with MesenCure, thus far, are very impressive and are significantly better compared to the results achieved with other therapies. All patients treated with MesenCure were in a severe condition, suffering from acute respiratory distress, diffuse pneumonia as per chest radiographs, and blood parameters indicative of a cytokine storm,” said Dr. Shadi Hamoud, the clinical trial’s lead researcher and deputy director of Haifa’s Rambam hospital department of internal medicine. “Moreover, about 90% of the trial participants suffered from co-morbidities known as risk factors for increased disease severity, complications, and mortality.”

“We hope to treat a large number of patients with this cell therapy, and we will strive to extend its use to other indications as well,” Hamoud added.

Bonus Biogroup believes MesenCure may be used for the treatment of other indications, including lower respiratory tract infections, asthma, and chronic obstructive pulmonary disease caused by viral or bacterial infection — which together represent a global market that is expected to exceed $43 billion per year, by 2026, not including the COVID-19 effect.

According to Meretzki, a major drawback of most cell-based therapies for the treatment of COVID-19 patients is that that they were not developed for lung diseases, and have therefore failed to show clinical efficacy.

Going forward, should MesenCure receive necessary regulatory approval for general use, its maker will face logistical issues in how to best fit production with the drug’s short shelf life of seven days

Meretzki also disclosed that the company is in talks with a number of countries about the potential use of MesenCure.

“Israel was vaccinated about six months before the rest of the world and is just coming out of the fourth COVID wave, which other countries like the UK, Romania, Italy, and Germany are now dealing with,” he said. “Our goal is to help as many severe COVID patients survive as possible — globally.”