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Sunday, 15 January 2023 14:46

Success in obtaining certification of compliance with industrial manufacturing standards for Phase III clinical trial in severe COVID patients

The Israel Ministry of Health certified the facility and process for producing the investigational drug MesenCure to comply with Good Manufacturing Practices (GMP) according to the recommendations of the World Health Organization.


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 that on January 11, 2023, the Israel Ministry of Health approved that the manufacturing process of MesenCure for a Phase III clinical trial complies with the industrial standards of Good Manufacturing Practices (GMP). The Ministry of Health has further certificated that the MesenCure manufacturing site located in the new Bonus BioGroup Center in Haifa also complies with the GMP requirements recommended by the World Health Organization (WHO) and according to the Israeli laws and regulations.

In the USA alone, over two million COVID patients were admitted to hospitals in 2022, of which about 320 thousand patients were in severe condition, and over 100 thousand COVID patients died [1]. In Israel, about 12,000 COVID patients were hospitalized in severe condition [2], during the same year, and 3,744 COVID patients died1.

The Company has previously demonstrated that MesenCure effectively reduced the mortality of severe COVID patients by 68% [3]. Assuming similar performance, it is likely that in 2022 alone, it could have been possible to save the lives of approximately 2,300 severe COVID patients who died in Israeli hospitals if they had received MesenCure.

In response to the urgent global need for a remedy for severe COVID patients, the Company is preparing for a Phase III multinational clinical trial to study MesenCure efficacy and safety in such patients. The urgent clinical need we address is emphasized by a mortality rate of approximately 20% among severe COVID patients [4] and even higher rates in certain territories, despite the best available standard of care. The approvals granted by the Israel Ministry of Health will now allow the Company to manufacture MesenCure for this Phase in Israel.

Dr. Shai Meretzki, Bonus Biogroup's CEO, stated that "to the best of our knowledge, with these approvals granted, Bonus Biogroup may be the only Company in Israel and one of only a few in the world that is GMP certified to manufacture advanced cell therapy products for severe COVID patients. Following a successful Phase II clinical trial and a demonstration of MesenCure's outstanding safety and efficacy, I believe that Bonus Biogroup now stands at the forefront of the global race to develop a real cure for severe COVID patients for a target market of millions of patients every year. The Company's success in obtaining GMP certificate and Manufacturer authorization is an important milestone, also towards testing and implementing MesenCure in additional indications to improve human health."

MesenCure outstanding efficacy is not affected by the COVID variant as it does not act directly against the virus. Instead, MesenCure regulates and alleviates the life-threatening acute inflammation and cytokine storm triggered by the virus in severe COVID patients.

In addition to the MesenCure production line, a separate facility was established in the new Bonus Biogroup Center to produce BonoFill, a viable human bone graft. Each newly established production facility includes clean rooms for cell and tissue culture according to GMP standards. In addition, the facilities are equipped with the infrastructure and control systems required for continuous production monitoring. Moreover, they include areas and equipment for cell and tissue storage, product assembling, and packaging. All facilities were established to comply with the standards for manufacturing cell-based products for human use as required by regulatory authorities in the United States (FDA), Europe (EMA), and Israel.

The new Bonus Biogroup Center and its two production facilities were designed to meet the manufacturing capacity required for both BonoFill and MesenCure clinical trials, planned to be conducted simultaneously in Israel and abroad and even allow commencing commercial-scale manufacturing. Both manufacturing facilities were designed to implement automation and reduce manual manipulations, increase manufacturing productivity, and improve the quality and safety of the products while saving on human labor and additional costs.

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 cytokine release syndrome 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 seven families of patents and patent applications, encompasses thirty-eight (38) approved patents and seventeen (17) 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] https://github.com/owid/covid-19-data/tree/master/public/data; https://gis.cdc.gov/grasp/covidnet/covid19_5.html

[2] According to Israel Ministry of Health data (hospitalized patients’ data) from https://data.gov.il/dataset/covid-19

[3] For more details, see an immediate report dated January 10, 2022 (Reference: 2022-01-005083)

[4] Yek C, Warner S, Wiltz JL, et al. Risk Factors for Severe COVID-19 Outcomes Among Persons Aged ≥18 Years Who Completed a Primary COVID-19 Vaccination Series — 465 Health Care Facilities, United States, December 2020–October 2021. MMWR Morb Mortal Wkly Rep 2022;71:19–25. DOI: http://dx.doi.org/10.15585/mmwr.mm7101a4

Last modified on Monday, 15 May 2023 08:23

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