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Wednesday, 13 May 2020 13:12

Preliminary pre-clinical study results with the unique drug product MesenCure, developed by Bonus Biogroup for the treatment of life-threatening respiratory distress in COVID-19 and pneumonia patients

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Successful treatment of acute pneumonia, demonstrating that following the administration of MesenCure, the treated lung appeared as a healthy lung


Bonus BioGroup (TASE: BONS.TA), a clinical-stage Israeli biotechnology company engaged in research and development of biomedical tissue engineered and cell therapy products, is pleased to announce the preliminary pre-clinical study results of a novel, unique drug product  MesenCure (hereinafter: "the Study"), developed by the Company specifically for the treatment of life-threatening acute respiratory distress in COVID -19 and pneumonia patients, which has demonstrated the successful treatment of acute pneumonia in an animal model. This success is reflected in the fact that following the treatment with MesenCure, the microscopic appearance of the treated lungs was similar to a healthy lung, and a significant improvement in additional related parameters was achieved.

In a healthy lung tissue, the pulmonary alveoli are wide open. In contrast, in the non-treated, injured lung tissue sample, acute inflammation is seen, which is characterized by extensive infiltration of immune cells, thereby, interfering with the lungs’ normal function and leading, among others, to a cytokine storm. Following the unique treatment with activated mesenchymal cells, of which Bonus BioGroup’s drug MesenCure consists, success was achieved in the rapid cure of pneumonia symptoms, which was demonstrated by the reduction of the immune cells burden in the pulmonary alveoli to a level similar to that seen in healthy lung tissue.

BioGroup Bonus is developing MesenCure specifically to treat the respiratory symptoms of COVID-19 patients by reducing the inflammatory process in the respiratory system, allowing the injured lungs to recover. Other companies, however, are evaluating in clinical trials the efficacy of their products in the treatment of COVID-19 patients mostly using drugs previously developed for indications unrelated to the respiratory system. To the best of the Company's knowledge, of nine mesenchymal cell-based products scheduled to be clinically tested, none was originally intended by its developers to treat respiratory inflammation.

In contrast, MesenCure is specifically developed for the treatment of respiratory tract inflammations, whether due to COVID-19 or any other viruses, due to bacterial infection, or exposure to other contaminants. Focusing specifically in the field of respiratory inflammation during development ensures the product’s maximal efficacy and safety in a variety of indications, that together represent a global market of over USD 43 billion annually, such as infections of the lower respiratory tract, COVID-19 and pneumonia, as well as asthma and chronic obstructive pulmonary disease.

The drug MesenCure contains activated mesenchymal cells (MSCs), derived from the adipose tissue of healthy human donors. The mesenchymal cells’ activation is achieved by an innovative and unique combination of chemical and biological substances as well as physical conditions, prior to their transplantation in the patients, designed to increase the cells’ efficacy while maintaining their safety. Following their intravenous transfusion, the activated cells are expected to reach the lungs, reduce inflammation, restore the tissue, and relieve respiratory and other symptoms.

The Study was conducted on an animal model suffering from severe respiratory distress symptoms, an accepted preclinical model for this condition. These symptoms are similar to those of COVID-19 patients, which include massive infiltration of immune cells to the lungs, a marked increase in lung fluids (edema), a decrease in blood lymphocytes cell counts, whose role is, among others, to fight viruses, as well as other symptoms common to COVID-19 patients and are associated with poor prognosis.

The experimental results were in agreement with the anti-inflammatory activity of mesenchymal cells as reported in the professional literature, and demonstrated that naïve, non-activated mesenchymal cells from Bonus BioGroup lowered, to some extent, the levels of monocytes and neutrophils (white blood cells belonging to the immune system) in the blood of animal models. A higher level of these cells is the result of immune system overactivity, and is associated with poor prognosis, including in COVID-19 patients.

However, the preliminary results demonstrated that only MesenCure’s activated mesenchymal cells, produced by BioGroup Bonus, but not naïve mesenchymal cells which were not activated by this innovative technology, were able to significantly reduce by about 47% the pulmonary edema in the treated animals, compared to the untreated animals. This result indicates the ability of the activated cells in MesenCure to relieve acute pneumonia and to reduce pulmonary edema, which is a life-threatening condition in COVID-19 patients.

In addition, only MesenCure’s activated mesenchymal cells, produced by Bonus BioGroup, demonstrated in this Study the ability to significantly increase blood lymphocyte counts, highlighting the unique potential of MesenCure to alleviate life-threatening lymphopenia (low blood lymphocyte level) in COVID-19 patients.

The efficacy results of MesenCure’s activated mesenchymal cells, developed by Bonus BioGroup, emphasize, compared to the low efficacy of naïve, non-activated mesenchymal cells, the importance of this activation, developed and implemented by the Company, to treat respiratory symptoms of COVID-19 patients. Also, these results emphasize the necessity to test and optimize these activations.

Since its establishment, Bonus BioGroup has been involved in cell-based tissue engineering for the purpose of tissue regeneration in various indications. Currently, the company is focusing on developing and producing a viable bone graft for bone repair in a variety of indications. The central building block used to make a viable bone graft are mesenchymal cells derived from the patient's adipose tissue.

With the outbreak of the COVID-19 pandemia, the Company began experimenting with those mesenchymal cells, which in this case originate from adipose tissue of healthy donors, with the intention to enhance their ability to alleviate inflammatory processes, specifically in the respiratory tract, and the cytokine storm seen in COVID-19 patients and other respiratory illnesses.

Cytokine storms can cause immune system overactivation, thereby, attacking healthy cells and tissues, including pulmonary alveoli, leading to their occlusion by excess fluids, as well as proteins and cell debris. In the respiratory process in a healthy person, red blood cells that reach the capillaries adjacent to the lung alveoli absorb oxygen, which is then transferred to the body's tissues, and release carbon dioxide that is absorbed from the body's tissues and is eliminated through the lungs. In COVID-19 and pneumonia patients, obstruction of the pulmonary alveoli and other damages caused by the immune system's over-reaction can lead to acute and life-threatening respiratory distress.

In the development of MesenCure, Bonus BioGroup utilizes unique technologies and knowledge under development as well as technologies that are already part of the Company’s wealthy IP estate, consisting of fourteen approved patents and eighteen patent applications, in many countries around the world.

According to the Forum of International Respiratory Societies, more than 1 billion people, worldwide, are suffering from inflammatory diseases of the lower respiratory tract, which cause an estimated 7.5 million deaths each year[1], and are the third leading cause of death in Europe[2], not including COVID-19 mortality data. By 2026, the global market for acute respiratory distress syndrome, chronic obstructive pulmonary disease, and asthma alone is expected to exceed USD 43 billion[3],[4],[5]. This data, as well, does not include the expected impact of COVID-19.

According to the research unit of the international media company The Economist, about half of the world’s population is expected, eventually, to contract the virus causing COVID-19[6]. Although most of the infected people will not show any symptoms or, even if they do, they will recover without any treatment, a significant portion of the world’s population, including people aged 65 and over, and those suffering from background diseases or a weak immune system, are in grave danger to develop severe symptoms. According to this estimate, about 20% of those infected with the new coronavirus are expected to develop a serious illness, with 3% of the people infected may require invasive ventilation[7].

Currently, over four million people are infected with COVID-19, with millions more that are expected to join them in the coming months, followed by additional widespread epidemic-like infections that may occur in the coming winters. Epidemiologic models based on the previous outbreak of SARS have predicted that in the next two years, more global outbreaks of COVID-19 will take place, which in the future may become one of the seasonal winter diseases[8],[9].

Under these circumstances, and in the absence of dedicated or adequate therapeutic options for life-threatening pneumonia in COVID-19, Bonus BioGroup’s MesenCure may be a life-saving option for millions of patients each year, in a multibillion-dollar global market.

The drug MesenCure is manufactured at Bonus BioGroup’s manufacturing facility, which includes manufacturing suites, quality control and assurance units, and meets the standards required to produce clinical-grade cellular products suitable for the clinic. This facility currently serves the Company for the manufacturing of a viable human bone graft that is transplanted in patients participating in the Company’s two ongoing clinical trials for bone regeneration in the jaw or limb bones.

Bonus BioGroup employees are proud to take part in the global effort to fight COVID-19.

The Company's estimates of forward-looking statement

Biographic bonus assessments of the medical effect and / or commercial potential of the drug MesenCure, the Company's ability to continue the drug development process, including experimentation and arrival in human medical application product, and the expected timelines for any trial, are forward-looking information, as defined The Securities Law, 1968, based on the Company's assessments and information in its possession, at the reporting date.

There is no certainty that these intentions will be realized, in whole or in part, among others, due to the dependence of third parties actions that are not under the control of the Company, the possibility of delay in obtaining relevant regulatory approvals and / or a change in the relevant conditions and / or feasibility studies that the Company may conduct, and / or delay in conducting of studies and / or the need for further studies and / or failure of studies and / or technological changes and / or development and marketing of similar and / or more effective competing products and / or lack of availability of resources and / or realization of any of the risk factors related to research and / or trials and / or its results.

 

Sincerely,

Bonus BioGroup

By: Yossi Rauch (Chairman of the Board) and Dr. Shai Meretzki (CEO and Director)

 

 

[1] Forum of International Respiratory Societies. The Global Impact of Respiratory Disease – Second Edition. Sheffield, European Respiratory Society, 2017.

[2] https://www.oecd-ilibrary.org/social-issues-migration-health/health-at-a-glance-europe-2018/mortality-from-respiratory-diseases_health_glance_eur-2018-12-en

[3] https://www.coherentmarketinsights.com/press-release/global-chronic-obstructive-pulmonary-disease-copd-treatment-market-to-surpass-us-218-billion-threshold-by-2026-1411

[4] https://www.bloomberg.com/press-releases/2019-06-13/global-asthma-therapeutics-market-to-surpass-us-20-4-billion-by-2026-coherent-market-insights

[5] https://www.reportsanddata.com/report-detail/acute-respiratory-distress-syndrome-ards-market

[6] Chloe Taylor. Coronavirus will infect half the global population, EIU predicts. CNBC.

[7] Meng L, Qiu H, Wan L, et al. Intubation and Ventilation amid the COVID-19 Outbreak. Anesthesiology. 2020;(Xxx):1. doi:10.1097/ALN.0000000000003296.

[8] Neher, R.A., Dyrdak, R., Druelle, V., Hodcroft, E.B. and Albert, J., 2020. Potential impact of seasonal forcing on a SARS-CoV-2 pandemic. Swiss Medical Weekly, 150(1112).

[9] Kissler, S.M., Tedijanto, C., Goldstein, E., Grad, Y.H. and Lipsitch, M., 2020. Projecting the transmission dynamics of SARS-CoV-2 through the post-pandemic period. medRxiv.

 

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