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Sunday, 29 August 2021 04:19

Bonus BioGroup is preparing to adjust its manufacturing capacity for an increase in severe Covid-19 patients - leased a building at Matam Park, Haifa

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Following the approval by the Israeli Ministry of Health for additional medical centers to join in phase II clinical trial for the treatment of severe Covid-19 with Bonus BioGroup's drug product MesenCure
Bonus BioGroup is preparing to adjust its manufacturing capacity for an increase in severe Covid-19 patients - leased a building at Matam Park, Haifa


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 August 26, 2021, its board of directors approved the agreement with Matam Scientific Industries Center Haifa Ltd. (hereinafter: "the lessor") to lease the building known as Building 20, in Matam park, Haifa, Israel (hereinafter: "Building 20") in its entirety, comprising ​​approximately 21,500 sq. ft. (2,300 sqm.), including ancillary areas.

This announcement follows an immediate report dated August 11, 2021[1], regarding the approval by the Israeli Ministry of Health for additional medical centers to join in phase II clinical trial for evaluating the efficacy and safety of MesenCure in the treatment of severe Covid-19 patients suffering from life-threatening pneumonia and respiratory distress (hereinafter: "the clinical trial for the treatment of respiratory distress").

Bonus BioGroup’s move to increase production capacity for the COVID-19 treatment coincides with a dramatic spike in infection rates in Israel, despite having one of the highest vaccination rates per capita worldwide.

About half of Building 20’s area is designated for industrial-scale production of the company's two drug products: BonoFill - viable bone graft for bone tissue regeneration; and MesenCure - a cell therapy for the treatment of severe Covid-19 patients; in two separate manufacturing facilities, each of which will include cleanroom facilities as well as a laboratory for microbiology and quality assurance, to support the manufacturing of the company's products. The company's cleanroom facilities will be at GMP level, grade B. In addition, they will contain equipment and control systems for continuous monitoring, at a level required to meet the FDA's and EMA's requirements for the production of cell-based therapeutic products intended for human treatment.

The production capacity of the company's drug products in the new manufacturing facilities may allow Bonus BioGroup to scale up to industrial-scale production of the company's two drug products, including the drug product MesenCure, to supply the quantity required for the treatment of severe Covid-19 patients in the medical centers joining in the clinical trial for the treatment of respiratory distress.

The other half of Building 20’s area is intended for research and development activities and the company’s regulatory, clinical, and administrative personnel.

Dr. Shai Meretzki, the CEO of Bonus BioGroup, states that: “The world is getting ready to live alongside the Coronavirus, including more aggressive variants, for years to come. Effective vaccines will be required during this period to protect the population and medications for treating the critically ill. Such a combination of effective vaccines and drugs may allow us to keep a routine that resembles how we lived before the pandemic.  From this position, Bonus BioGroup is transitioning to industrial-scale production of its products, including MesenCure, in a modular manner, adjustable to the quantities required amid the growing numbers of severe patients.”

In addition, Bonus BioGroup entered into a contractual agreement with the previous lessee of Building 20 (hereinafter: "the previous lessee"), according to which the company is entitled to receive from the previous lessee the amount of NIS 3.7 million in cash, plus VAT, no later than September 5, 2021, in exchange for the agreement to lease Building 20 starting May 1, 2021, until July 31, 2024 (hereinafter: “the rental period”). During the rental period, the company will pay the lessor a monthly rent in the amount of approximately NIS 155,000, plus VAT, linked to the consumer price index (hereinafter: "the monthly rent").

Bonus BioGroup is entitled to extend the rental period for two additional periods, lasting three years each, for a 3% increase in monthly rent for each additional rental period.

In phase I of the clinical trial for the treatment of respiratory distress, the safety and efficacy of the drug product MesenCure was demonstrated. A significant reduction in pneumonia was demonstrated by chest X-ray images of severe Covid-19 patients treated with MesenCure showing a reduction in the median lung area covered by inflammation from 55% before treatment to 15% within about only 5 days following treatment start, and up to a negligible median coverage of only 1% of the lung area, about three weeks following treatment end. After MesenCure treatment, the respiratory functions of the Covid-19 patients improved, returning blood oxygen saturation to a median of 95%. The severe patients treated with MesenCure were discharged from the hospital after a median duration of one day only after treatment end, and requiring no respiratory support. This excellent outcome in the treated severe Covid-19 patients was achieved despite 90% of them also suffering from severe background diseases, known as risk factors for serious illness, complications and mortality, at a rate over 35%[2].

MesenCure is intended to treat life-threatening respiratory distress, regardless of its origin; whether caused by the original Covid-19 strain or any other variant, by another virus, or whether caused by a bacterial infection or other.

Taking into account the emergence of more virulent coronavirus strains[3], which will lead to further infection waves, and considering the significant decrease in the effectiveness of vaccines merely months following vaccination, as well as to a worldwide vaccines shortage that is expected to last several years, the company estimates that in the coming years, vaccines will have no significant impact on the market positioning of MesenCure.

Experts' opinions presented in January 2021 in the prestigious scientific journal Nature, support the projection that despite vaccination, Covid-19 will not disappear but become an endemic disease, with stable occurrences[4], similar to influenza, affecting more than 10% of the population each year[5]. Hence, the company estimates that regular incidences of millions of severe Covid-19 patients are expected worldwide each year, which may be the target population for MesenCure.

Since its establishment, Bonus BioGroup has been engaged in cell-based therapy and tissue engineering for bones’ reconstruction and regeneration via a viable, human bone graft product grown outside the patient’s body from cells isolated from the patient’s adipose tissue.

Bonus BioGroup is conducting a multi-center, phase II clinical trial for the treatment of critical bone defects in long bones, arm or leg, in five medical centers in Israel, as well as a phase II clinical trial for bone regeneration of extensive bone deficiencies in the jaws, upper or lower jaw bone, using an injectable, viable, human bone graft.

The existing alternative solutions for Bonus BioGroup’s injectable, viable, human bone graft are a surgical procedure for harvesting bone from the patient's body, which, in some cases, also include peripheral blood vessels and its implant in the patient's defect site, or alternatively, using synthetic bone graft materials, which in most cases will not lead to healing and will not allow the patient to return to normal functioning, due to the lack of a natural connection between the synthetic bone material and the human body.

The treatment with Bonus BioGroup’s viable, human bone graft, manufactured from cells isolated from the patient’s adipose tissue, reduces the risk of complications and graft rejection. Moreover, transplantation of BonoFill does not require a complex surgical procedure and may accelerate the patient's rehabilitation.

Company estimations regarding the forward-looking statement

Bonus BioGroup's assessments regarding the therapeutic effect and /or the marketing potential of the viable, human bone graft BonoFill or the cell therapy MesenCure, the company's ability to continue the development of the drug, including the conduct of clinical trials, and the manufacturing of a high-quality clinical-grade drug product, for the time periods expected to conduct any stages in any trial, are 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 this information will be realized, in whole or in part, among others, due to dependence on 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] Reference 2021-01-130359

[2] According to a meta-analysis of 52 observational studies of above 43000 severe Covid-19 patients with similar medical condition to that of the participants in the trial for the treatment of respiratory distress. https://associationofanaesthetists-publications.onlinelibrary.wiley.com/doi/10.1111/anae.15425

[3] https://www.usatoday.com/story/news/health/2021/02/16/covid-19-us-fourth-wave-variants-coronavirus/4460958001/

[4] Phillips, N., The coronavirus is here to stay - here's what that means. Nature, 2021. 590(7846): p. 382-384.

[5] https://www.cdc.gov/flu/about/burden/2018-2019.html

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