Bonus BioGroup’s product is back in the news again as its cell therapy promises to treat late-stage COVID-19.
Although vaccines effectively prevent COVID-19, particularly severe disease and death, and new antibody therapies and antiviral drugs promise to prevent disease progression, it is still challenging to treat late-stage COVID-19. An Israeli company’s product is back in the news again as its cell therapy promises to treat late-stage COVID-19.
In July, Bonus BioGroup, based in Tel Aviv, Israel, reported additional data on its Phase I/II clinical trials for MesenCure. In May, it had reported complete success in treating severe COVID-19 patients with pneumonia and acute respiratory distress. The new data provided information on the effectiveness of the treatment against new variants, waning vaccine efficacy, and a rise in global infection rates.
In a recent interview with Fox News, Tomer Bronshtein, head of research at Bonus BioGroup, discussing the Phase II trials, said, “These are the most clinically meaningful results presented today for treating severe COVID-19 patients,” and that MesenCure can “save three out of four people that are at risk of dying” and “can reduce their hospital length of stay by half.”
Bonus BioGroup focuses on cell therapies and tissue-engineered products for bone regeneration. The primary components of their bone graft technology are mesenchymal stromal cells isolated from a patient’s adipose (fat) tissue. But because of COVID-19, they decided to study the mesenchymal cells and their ability to decrease the hyper-inflammatory response, such as cytokine storms, associated with the disease and other illnesses.
In the latest data, the company observed a decreased risk of multiorgan dysfunction, heart and kidney injuries, and venous thromboembolism (VTE) in COVID-19 patients after they received the first dose of MesenCure. The effect of multiple doses appeared cumulative; in other words, the more they received, the better they responded. The results came from the July data analysis in a Phase I/II study at the Rambam Health Care Campus in Haifa, Israel.
In the analysis, in the severe COVID-19 cases that received MesenCure, 90% had pre-existing conditions that put them at risk of severe disease and complications, with a mortality rate of more than 35%. After treatment, there was a significant improvement in overall respiratory function and a significant reduction in the area of diffuse lung inflammation.
For less objective measures, they also found improvements in general health, including mobility, ability to take care of themselves and perform routine behaviors, degree of pain, and anxiety.
“The treatment results of MesenCure are thus far very impressive and are significantly better compared to those achieved with other therapies,” said Dr. Shadi Hamoud, head of the Research Unit and deputy director of the Department of Internal Medicine at Rambam Medical Campus, in July. “All patients treated with MesenCure were in a severe condition and suffered from acute respiratory distress, diffuse pneumonia (as per chest radiograph), and blood parameters indicative of a cytokine storm. Moreover, about 90% of the trial participants suffered from comorbidities known as risk factors for increased disease severity, complications, and mortality.”
As a result of the July data, the Israel Ministry of Health (IMOH) approved the move to Phase II. These trials will include up to 50 more severe COVID-19 patients. Hamoud is supervising the study at Rambam.
In the original May announcement and presentation at the International Society for Cell & Gene Therapy 2021 annual meeting in New Orleans, the company noted the therapy demonstrated a rapid reduction around diffuse lung inflammation from a median of about 55% of lung area before treatment to about 15% after five days. Improvement in respiratory function went from low blood oxygen saturation levels caused by acute respiratory distress to about 95% at the end of treatment. Tissue injury decreased as demonstrated by a median decrease of 22% in the enzyme lactate dehydrogenase (LDH) and a median drop of 72% in the enzyme creatinine kinase (CK) and a return to normal levels.
