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Tuesday, 18 June 2024 12:39


Bonus Biogroup is pleased to announce that on June 18, 2024, at the annual meeting of the International Society for Applied Biological Sciences (ISABS) [1], the Company disclosed that, pursuant to an outline agreed upon with the U.S. FDA, it has successfully completed the development of a unique quality control test for MesenCure, a cell therapy drug for treating inflammation and tissue damage. In developing this test, based on measuring the intensity of the drug's biological activity (potency), the Company achieved an essential milestone for transitioning from a Phase II clinical trial to a Phase III clinical trial in the United States for the treatment of respiratory distress in severely ill patients using MesenCure.

This announcement was included in the Company's lecture at the conference, where it also presented results from clinical trials for the two advanced products developed by the Company – BonoFill and MesenCure – as well as its contributions to advancing regenerative medicine via cells and tissue priming for the successful translation of effective and accessible therapies [2].

The Company's presentation was part of a series of lectures on translational medicine held at ISABS's annual conference in Split, Croatia, in collaboration with the Mayo Clinic [3], a leading hospital chain in the United States [4].

Potency is one of the critical quality attributes of any drug. The FDA and other regulatory bodies require that drug quality controls include a potency test as a prerequisite for transitioning from Phase II to Phase III clinical trials. Developing potency tests for biological drugs, especially drugs like MesenCure, which consists of living cells, poses a significant challenge [5]. This challenge may delay the clinical development of cell therapies, sometimes even for many years [6].

The unique potency test developed for MesenCure quality control is intended to reflect the biological mechanism of action of the drug to assess its therapeutic effects in patients [7].

The test, developed and qualified by the Company under FDA guidance, includes laboratory measurement of the activity of a protein (enzyme) excessively expressed by the living cells in MesenCure. This protein functions as a catalyst for a chemical reaction, whose products have a moderating effect on inflammatory processes and a hyperimmune response. The innovative test developed by the Company can provide results in less than a day and replaces a standard test that measured MesenCure's ability to inhibit immune cell activity in culture. The standard test took about five days to yield results, which is unsuitable for fresh products like MesenCure.

As part of the certification of the activity test, the Company demonstrated a strong correlation (r=0.9) between the activity of the protein measured in the innovative potency test and MesenCure's ability to inhibit immune cell activity in the standard test. Additionally, a correlation was demonstrated between the specific inhibition of the measured protein and the reduced ability of MesenCure to moderate immune cell activity, indicating that this protein is a critical quality characteristic of MesenCure.

ISABS's annual conference, now in its 25th year, has attracted thousands of doctors, scientists, and policymakers from 78 countries. The conference is a focal point for many Nobel Prize winners. This year, four Nobel Laureates in Chemistry and Physiology or Medicine are presenting at the conference [8].

Prof. Dragan Primorac, President of ISABS, stated: "The development of a potency test is one of the most significant, if not the most significant, challenges in the development of cell therapies, especially those based on mesenchymal cells, such as MesenCure. The standard test, which measures the direct effect of the cellular drug on immune cells, could have been the preferred test to predict the effect of such drugs on patients, but the long time it takes to obtain results makes it very difficult to implement. This is especially true regarding a drug containing fresh cells with powerful activity, which needs to reach seriously ill patients as quickly as possible. Developing a quick and simple test, yet one that is highly correlated with the standard test, constitutes a significant technological leap, potentially enabling accelerated development and widespread application of cell therapies."

The Company estimates that MesenCure may be used to treat respiratory distress in a market expected to reach $23 billion annually in the U.S. alone by 2030 and potentially double that amount worldwide.

About Bonus Biogroup

Bonus Biogroup Ltd. is a clinical-stage biotechnology company dedicated to developing advanced therapies in tissue regeneration and biotech products using tissue engineering and cell therapy. The Company currently has two products in clinical development: BonoFill™, a live tissue-engineered human bone graft intended for bone tissue regeneration and rehabilitation, and MesenCure, a cell therapy designed to treat inflammation and tissue damage, including pneumonia and respiratory distress. Bonus Biogroup also maintains a variety of technologies and products in the preclinical development phase.

The development of these products involves the application of unique technologies and knowledge proprietary to Bonus Biogroup. The Company's robust intellectual property portfolio includes six families of patents and patent applications, comprised of thirty-three approved patents and eight patent applications, spanning numerous countries worldwide.

About BonoFill™ – A Live Human Bone Graft

Bone deficiencies can result from a wide variety of causes, including aging, infections, arthritis accompanied by bone loss, various types of trauma (accidents or falls), and cancerous tumors. Bonus Biogroup develops live grafts of injectable human bone based on cells sampled from the patient to reduce the risk of rejection. The cells sampled from adipose tissue are grown in a bioreactor on three-dimensional scaffolds for 2-3 weeks. This process yields a large amount of bone tissue, sufficient to create a live human bone graft that matches the patient's existing bone deficiency.

Growing bone grafts outside the patient's body allows bone grafts to be made upon request. These grafts can be effectively used for various medical needs, including oral and maxillofacial surgery, skull surgery, orthopedic surgery, and plastic surgery in cases lacking bone tissue. The company has completed a Phase II clinical trial to treat bone deficiencies in the upper or lower jaw bones using BonoFill™ [9]. The results indicate that BonoFill™ achieved complete success in bone reconstruction in 90% of the transplants conducted, with a reduction of approximately half to two-thirds of the healing period, enabling patients to return to their regular routine within a relatively short time.

In addition to the Phase II clinical trial for treating facial bone deficiencies, the Company is conducting a Phase II multicenter clinical trial to treat limb bone defects in the hand or leg at six medical centers in Israel. In these two clinical trials, bone deficiencies were treated using BonoFill™.

The company estimates that within the applications in which it conducts clinical trials, BonoFill™ could be used to treat bone deficiencies for bone regeneration and reconstruction in a market that by 2030 is expected to reach $25 billion annually in the U.S. alone and potentially double that worldwide.

The existing alternative solutions to using a live human bone graft manufactured by Bonus Biogroup are autologous (self) bone transplantation—surgery to harvest bone from another part of the patient's body, sometimes together with its peripheral blood vessels, and implant it in the deficient area—or using a bone graft substitute, which in most cases does not lead to healing and does not allow the patient to return to normal functioning due to the lack of a natural connection between the artificial bone replacement and the human body.

Unlike autologous bone transplantation, which is the standard treatment today, the bone graft produced by Bonus Biogroup is not taken from the patient's body, avoiding an invasive, dangerous, and complex procedure. Instead, it is grown in the laboratory in the required volume to fully address the bone deficiency in the patient's body, based on a sample of the patient's cells, in a fast, safe, and patient- and health-system-friendly procedure. Additionally, the live implantation of human bone is done by injection, does not require a complex surgical procedure, and may expedite the patient's rehabilitation.

About the drug MesenCure

Bonus Biogroup has completed a Phase II clinical trial for treating pneumonia and life-teetering respiratory distress in severe COVID-19 patients using the cell therapy drug MesenCure [10]. Clinical trial results indicate that MesenCure reduced the mortality rate of severe COVID-19 patients by 68% compared to the control group, with the survival rate standing at 94% for the 50 severe patients treated with the drug.

MesenCure, comprised of professionalized mesenchymal cells, aims to treat inflammation and tissue damage, including pneumonia and respiratory distress caused by the coronavirus or other viruses, bacterial infections, or other sources of immune overactivity, inflammation, or tissue damage.

The drug's effectiveness is attributed to the professionalization of the comprising cells, which enhances their natural ability to heal inflammation and tissue damage. The cells constituting MesenCure also affect inflammation and promote tissue regeneration through various mechanisms, potentially offering a broader and superior effect on diverse populations suffering from inflammation and tissue damage from multiple causes compared to drugs with a single mechanism of action.

The company estimates that MesenCure™ may be used to treat respiratory distress in a market that by 2030 is expected to reach $23 billion annually in the U.S. alone and potentially double that worldwide.

Given the successful demonstration of MesenCure's effectiveness in treating acute respiratory distress in severe COVID-19 patients, the Company has broadened its efforts to investigate the potential efficacy of the drug and its derivatives in treating other indications such as cytokine release syndrome resulting from immunotherapy treatments to activate the immune system against cancer or from hematopoietic stem cell transplantation, as well as in tissue rehabilitation and healing.

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.


Bonus BioGroup Ltd.

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


  1. International Society for Applied Biological Sciences (ISABS)
  2. Advancing the future of regenerative medicine: Cells and tissue priming for successful translation of effective and accessible therapies
  3. Mayo Clinic Lectures in Translational Medicine Program
  4. Mayo Clinic: Top-ranked Hospital in the Nation
  6. Take 3: Mesoblast plots path to market for twice-rejected cell therapy
  9. For more details, see Immediate Report dated June 2, 2024 (reference 2024-01-055699), which is included herein by reference.
  10. For more details, see Section 14.2 of Part A of the Company Annual Report for 2023, dated March 29, 2024 (reference 2024-01-034929), which is included herein by reference.
Last modified on Wednesday, 19 June 2024 12:42







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