Bonus BioGroup
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Sunday, 19 April 2020 12:44

Bonus BioGroup has initiated a preclinical study of a unique drug developed for the treatment of life-threatening respiratory distress in Corona (COVID-19) patients and pneumonia Featured

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Bonus BioGroup is pleased to announce that on April 19, 2020, it initiated a preclinical study (“the Study”) of a unique drug product termed MesenCure, specially developed by the Company for the treatment of acute and life-threatening respiratory distress in coronavirus (COVID-19) and pneumonia patients. The drug MesenCure consists of activated Mesenchymal Stromal Cells (“MSCs”) that are isolated from the adipose tissue of healthy donors. The activation of the MSCs before their administration is intended to boost their therapeutic efficacy while maintaining their excellent safety profiles and is achieved by exposing them to an innovative combination of chemical, biological, and physical conditions. Following intravenous transfusion, the activated cells are expected to reach the lungs and act to reduce inflammation, promote the regeneration of the diseased lung tissue, and alleviate respiratory and other symptoms.

The development of MesenCure relies on more than a decade of MSC-related experience and technologies gained by the Company in the development of its lead product, a tissue-engineered bone graft that is also based on MSCs. With the current coronavirus outbreak, Bonus BioGroup has started tissue culture studies into the potential of these MSCs, further activated, to alleviate inflammation, including in the lungs, and possibly attenuate the cytokines’ storm in COVID-19 patients. Such a storm is often associated with a too aggressive immune response and inflammation destroying, thereby, many tissues, including the lungs, and leading to their occlusion by excess fluids, proteins, and cell debris, and an overall respiratory distress syndrome.

Initial results, already obtained from these laboratory studies in tissue culture, have shown that subjecting the MSCs to various biological, physical, and chemical conditions has changed cellular attributes, which may be associated with greater anti-inflammatory potential. To further assess this potential and its possible therapeutic implications, Bonus BioGroup has initiated the Study. In addition, the MesenCure development initiative relies on Bonus BioGroup's profound understanding of MSC biology, in-house MSC manufacturing capacity, and technologies previously developed by the Company for the efficient and standardized isolation and cultivation of MSCs. Collectively, these capabilities place Bonus BioGroup in a unique position to enhance and fully realize the therapeutic potential of MSCs in MesenCure, and in a timeframe that is relevant for COVID-19.

Bonus BioGroup develops the drug MesenCure specifically for the treatment of respiratory symptoms of COVID-19 patients. At the same time, other companies mostly evaluate the effectiveness of drugs originally developed for indications other than COVID-19, including medicines that are not even related to the respiratory system. 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.

In May 2020, the Company is expected to announce preliminary results of the Study for the evaluation of MesenCure efficacy. In the third quarter of 2020, the Study is expected to be completed, after testing in several animal models, with an anticipated development cost, including manufacturing, that will not exceed 10% of the Company’s expenses during 2019.

The drug MesenCure is intended for the treatment of pneumonia, whether as a result of infection with coronavirus or any other type of virus or originating from a bacterial infection or exposure to other contaminants. Therefore, MesenCure may be useful for treating a variety of indications, such as lower respiratory tract infections, acute respiratory distress syndrome, asthma, and chronic obstructive pulmonary disease.

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 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 to contract the coronavirus eventually[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 percentage of the world’s population, including people aged 65 and over, and those suffering from background diseases or a weak immune system, are in real danger to develop severe symptoms. According to this estimate, about 20% of the people infected with the new coronavirus are expected to develop a serious illness, with 3% of the people infected, which may require invasive ventilation[7].

Currently, over two million people are infected with the new coronavirus, 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 coronavirus 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.

On February 20, 2020, Bonus BioGroup completed fundraising of approximately NIS 25.6 million in cash, against the allocation of shares for which, in the investment agreement, the price was NIS 0.50 per share, which is 52% above the Company’s share closing price of NIS 0.329 on April 16, 2020, prior to this report.

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

Company estimations regarding forward-looking statements

Bonus BioGroups 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] 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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