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Wednesday, 20 May 2020 09:54

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

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The success of Bonus BioGroup’s MesenCure in the treatment of acute pneumonia will be presented at the annual meeting of the International Society for Cell & Gene Therapy (ISCT)


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 that the Company has been invited to present its technological breakthrough in its promising preliminary pre-clinical results of the development of MesenCure, novel, cell-based drug product (hereinafter: "the Study"), developed specifically for the treatment of life-threatening acute respiratory distress in COVID-19 and pneumonia patients, to 1,800 scientists, physicians, and public opinion leaders from around the world, attending the conference of the International Society for Cell & Gene Therapy - "ISCT". The ISCT conference will be held May 28-29, 2020, via video broadcast.

ISCT is the world's leading professional society in the Company’s area of expertise. The presentation of Bonus BioGroup’s MesenCure to industry and academic leaders in the field of cellular therapy, is a recognition of Bonus BioGroup’s technology and its prospects.

According to experts in the Washington Post[1], even in the case that COVID-19 vaccines will be developed, with proven safety and efficacy against all COVID-19 virus subtypes, including still unknown subtypes, many years will pass until vaccination of about 5.6 billion people (about 70% of the world's population), which is the estimated minimum requirement for herd immunity, will be achieved. During these years, a global shortage of vaccines is expected due to the high demand.

Under these circumstances, even if safe and effective COVID-19 vaccines will be developed, these vaccines will not undermine Bonus BioGroup’s MesenCure position as an essential therapy for COVID-19 patients, for years to come. The Company estimates that the treatment of COVID-19 patients will consist of different treatment options, including vaccines, medication and supportive medical devices.

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, 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 preclinical study of the drug MesenCure is expected to be completed in the third quarter of 2020. In the preliminary study results, the treatment success is reflected in the fact that following the administration of MesenCure, the microscopic appearance of the treated lungs, was similar to a healthy lung. Moreover, only MesenCure’s activated mesenchymal cells, produced by Bonus BioGroup, were able to significantly reduce - by about 47% - the pulmonary edema in the treated animals, as well as significantly increase blood lymphocyte levels, highlighting the unique potential of MesenCure for the treatment of COVID-19.

Considering an imminent second wave of COVID-19 infection, which, according to Bloomberg News[2], already puts more than 100 million people in China facing renewed lockdown, and given the failure of health systems, in many developed countries, to care for large numbers of COVID-19 patients in life-threatening respiratory distress, the drug MesenCure may significantly reduce the number of severe and ventilated patients.

Hence, MesenCure may alleviate the burden on health care systems in their fight against COVID-19 pneumonia, thereby reducing the need for population lockdowns, maintaining daily routine, and minimizing global economic damage.

The drug product MesenCure contains activated mesenchymal cells, derived from 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 preliminary preclinical study results emphasize the importance of the cells’ activation for the successful treatment of acute respiratory distress.

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 pandemic COVID-19, 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 diseases.

Cytokine storms can cause immune system over-activation, 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.

The Company's estimates of forward-looking statement

Bonus BioGroup’s assessments of the medical effect and / or commercial potential of the drug MesenCure, the Company’s ability to continue the drug development process, including conducting trials and achieving a marketing-ready human medical drug product, and the expected timelines for any trial, is a forward-looking statement, as defined by the in the securities law 1968, which is based on the Company’s estimates and on the information in its possession at the time of reporting.

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] https://www.washingtonpost.com/business/2020/05/11/coronavirus-vaccine-global-supply/

[2] https://www.bloomberg.com/news/articles/2020-05-18/over-100-million-in-china-s-northeast-thrown-back-under-lockdown

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