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Monday, 22 May 2023 09:58

Bonus Biogroup and the Israel Institute for Biological Research reached an advanced stage in a joint study to examine MesenCure efficacy in treating acute respiratory distress and in rehabilitating lung damage caused by exposure to biological agents.


Bonus BioGroup (TASE: BONS) is a clinical-stage Israeli biotechnology company, engaged in research and development of biomedical tissue-engineered and cell therapy products.

Bonus Biogroup is pleased to announce entering an advanced stage in a joint trial in partnership with the Israel Institute for Biological Research (the "IIBR"). This study explores, among other things, the effectiveness of the cellular drug MesenCure in treating acute respiratory distress syndrome (ARDS) and rehabilitating lung tissue damage from various biological agents.

Previously, the Company and IIBR completed several successful joint preclinical trials under a signed agreement (the "Cooperation Agreement"). The results of these joint trials may suggest the effectiveness of MesenCure in treating acute lung injury (ALI) and acute pneumonia that results from it, even if not caused by COVID-19, leading to ARDS. This adds to the Company's demonstrated efficacy and safety of MesenCure in a phase II clinical trial for treating severe COVID-19 patients with pneumonia and life-threatening respiratory distress.

IIBR, a government research institute, conducts advanced research in biology, chemistry, and environmental sciences. Employing hundreds of leading scientists, IIBR has developed extensive knowledge and expertise in protecting against biological and chemical agents. Their work includes developing antibody-based technologies, advanced methods for discovering and identifying materials, disease treatment planning and development, and more.

Under the cooperation agreement, Bonus Biogroup provides MesenCure to IIBR for a joint study assessing its effectiveness, both alone and combined with other biological drugs developed by IIBR, in treating ALI from exposure to biological or chemical agents, pollutants, or pathogens. Given this research goal, the joint trials use only preclinical models. These trials' results may help hospitals and defense authorities better handle emergency and disaster situations within a national preparedness framework.

The cooperation agreement may expand the evidence supporting MesenCure's safety and potential efficacy for acute pneumonia, life-threatening ARDS, and lung damage rehabilitation from various medical conditions. Depending on the joint study's results, the Company might offer MesenCure to patients suffering from ALI, acute pneumonia, and ARDS caused by pathogens, pollutants, or other damages, regardless of COVID-19.

Epidemiological studies show that approximately 190,000 critically ill patients suffer from ARDS annually in the United States and Europe alone, irrespective of COVID-19 [1-3]. Despite receiving the best treatment available, primarily supportive respiratory care, these patients experience average mortality rates between 30% and 40%, or even higher [4]. ARDS patients, hospitalized for an average of 47 days [5], account for roughly nine million hospitalization days per year, costing over $14 billion annually in the United States and Europe [6].

Dr. Shai Meretzki, CEO of Bonus Biogroup, stated, "We are thrilled to deepen our collaboration with IIBR in developing more treatment options for those affected by exposure to biological or chemical agents. This partnership bolsters national preparedness for emergency and disaster situations while promoting public health and the security of the State of Israel. We are grateful to our partners from the IIBR, a highly respected research institute, for their successful cooperation in the joint research and their confidence in Bonus Biogroup's innovative technology."

Bonus Biogroup – the Company

Since its inception, Bonus BioGroup has been involved in cellular medicine and tissue engineering. To date, the Company has two products in clinical development: BonoFill - a viable human bone graft for the regeneration and reconstruction of bone tissue, and MesenCure - a cell therapy for acute inflammation, including acute respiratory distress in severe COVID patients. In addition, the Company has a variety of other technologies and products in preclinical development.

The main building block utilized to produce BonoFill bone graft is mesenchymal cells extracted from the patient's adipose tissue. Alongside the development of BonoFill, the Company developed a cell therapy based on mesenchymal cells isolated from adipose tissue of healthy donors that are professionalized to enhance their ability to counteract acute inflammation, including cytokine storms prevalent in COVID patients and other diseases. These efforts led to the development of the professionalized cell therapy product MesenCure.

In light of the Company's demonstration of the efficacy of MesenCure in treating severe COVID patients, the Company has expanded its efforts to examine the potential of MesenCure to treat other conditions involving systemic inflammations and multi-organ injuries. Such conditions include CRS caused by biological therapies or hematopoietic stem cell transplantation.

In developing its drug products, Bonus BioGroup uses unique technologies and knowledge developed in-house. The Company's rich intellectual property, including six families of patents and patent applications, encompasses twenty-eight approved patents and fifteen patent applications in many countries worldwide.

BonoFill – a viable human bone graft

Bone deficiencies can result from various causes, including aging, infections, arthritis accompanied by bone loss, trauma (accident or fall), and tumors. Bonus Biogroup develops viable human bone grafts based on cells sampled from the patient (autologous tissue). Growing bone grafts outside the patient's body allow their on-demand manufacturing to provide effective bone grafts for various medical conditions involving bone loss, including oral and maxillofacial surgery, cranial surgery, orthopedic surgery, and plastic surgery.

MesenCure cell therapy

The cell therapy MesenCure consists of professionalized mesenchymal cells. MesenCure is designed to treat acute inflammations and subsequent conditions. These conditions may include life-threatening pneumonia and respiratory distress, whether caused by the coronavirus, any other virus or bacterial infection, or whether caused by other conditions underlined by a hyperactive immune system. The efficacy of MesenCure, as demonstrated in the clinical trial for treating severe COVID patients, is presumably attributed to the professionalization of the mesenchymal cells comprising MesenCure. This professionalization enhances the cells' natural ability to attenuate the inflammation and cytokine storm, which, without MesenCure, could lead to life-threatening multi-organ damage. Furthermore, the cells comprising the drug product MesenCure affect inflammation and cytokine storm through various mechanisms. Therefore, MesenCure may have a broader and more robust effect on diverse populations of patients than drugs acting via a single mechanism.

Company estimations regarding forward-looking statements

Bonus BioGroup's assessments regarding the medical effect and/or commercial potential of its products and/or the resulting economic opportunities, and the Company's ability to continue the process of their development, including conducting studies, and arriving at a product that can be medically applied in humans, for the duration and expected dates to perform any stage in any experiment and publish its results and obtain regulatory approvals for marketing the product, are forward-looking statements, as defined by the Securities Law of 1968, which are based on the Company's estimates and on the information in its possession at the time of reporting.

There is no certainty that these estimates will materialize, in whole or in part, among others, due to dependence on the actions of third parties, which are not under the Company's control, on the development of future cancer therapies, on future studies results, if any, due to the possibility of delay in obtaining approval from relevant authorities and/or change in the relevant conditions and/or feasibility tests that the Company may conduct and/or delay in performing studies and/or need to perform further experiments and/or failure of experiments and/or technological changes and/or the development and/or marketing of similar and/or more efficient competing products and/or the lack of resources and/or the realization of any of the risk factors associated with the research and/or studies and/or its results.

Sincerely,

Bonus BioGroup Ltd.

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

[1] Epidemiology and Risk Factors of ARDS: How Many Is the Real Incidence of ARDS? https://link.springer.com/chapter/10.1007/978-981-16-8371-8_2

[2] The ALIEN study: incidence and outcome of acute respiratory distress syndrome in the era of lung protective ventilation https://doi.org/10.1007/s00134-011-2380-4

[3] According to an aggregated population base of 865 million in Europe and the US and an average ARDS incidence of 22 per 100,000 person-years.

[4] Acute Respiratory Distress Syndrome, Advances in Diagnostic Tools and Disease Management https://link.springer.com/book/10.1007/978-981-16-8371-8

[5] Information on ARDS. What are the costs and outcomes of ARDS? https://www.faron.com/patients-and-physicians/information-ards

[6] Based on the estimated hospitalization cost in Europe of approximately $1,600 per day, this average takes into account both general wards (482 euros per day) and intensive care units with and without ventilation (1,972 euros and 1,601 euros per day, respectively). These costs are weighted according to the average lengths of stay for ARDS patients in general wards (11 days) and intensive care units (36 days, including 17 days with ventilation). This estimation, derived from average European hospitalization costs, is likely an underestimate for the United States, where hospitalization costs are generally higher. The hospitalization durations and costs are obtained from various sources held by the company.

Last modified on Monday, 22 May 2023 12:38

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