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Sunday, 19 May 2024 09:38

Bonus Biogroup Invited to Present Final Results of Phase II Clinical Trial for Treating Facial Bone Deficiencies Using BonoFill™ at the Annual Meeting of the International Society for Cell and Gene Therapy

Bonus Biogroup is pleased to announce that it will present the final results of a Phase II clinical trial for treating facial bone deficiencies in the upper or lower jaw bones using BonoFill™—a live human bone graft manufactured by the Company (hereinafter: "Clinical Trial to Treat Facial Bone Deficiencies"). This presentation will be part of a unique session [1] on May 31, 2024 [2], at the annual meeting of the International Society for Cell & Gene Therapy ("ISCT").

The Company estimates that by 2025, approximately 3.4 million facial bone graft procedures could be performed in the United States alone, representing a market valued at $7.7 billion annually in this territory and potentially double that amount worldwide [3].

In recognition of the Company's continuous achievements, the ISCT invited Bonus Biogroup to present the results of the Clinical Trial to Treat Facial Bone Deficiencies at its annual conference, held from May 29 to June 1, 2024, in Vancouver, Canada [4]. ISCT is the world's leading professional association in the Company's field of activity [5]. The pinnacle of the Society's activities is its annual conference, which attracts thousands of scientists, physicians, and industry and opinion leaders from around the world, all engaged in the safe and effective application of cell therapies.

Dr. Shai Meretzki, CEO of Bonus Biogroup, said: "The completion of the second phase of the clinical trial to treat facial bone deficiencies is an important milestone in the development of BonoFill™ and the Company's trajectory. Recently, we reported significant technological breakthroughs, including the approval of patents for a unique gene expression profile of cells for transplantation [6] and a network of artificial blood vessels that can be integrated into any engineered organ [7]. These groundbreaking technological and clinical achievements have earned the Company international recognition as a world leader in biotechnology and cell therapy innovation. This recognition is reflected, among other things, in our receipt of the Advanced Therapies Award 2024, the first time this award has been given to an Israeli company [8]. Concurrently, the Company expanded the deployment of medical centers where the clinical trial for treating limb bone defects using BonoFill™ was conducted, making this limb-saving treatment accessible to patients in southern Israel, including soldiers and civilians injured in events that began on October 7, 2023, in Israel [9]. These developments underscore the Company's commitment to developing the 'next generation' of treatments in regenerative medicine and realizing our vision for the well-being of patients."

The clinical trial to treat facial bone deficiencies was conducted in Israel, in parallel with the Phase II clinical trial for treating limb bone defects—hand or leg—conducted by the Company in six medical centers in Israel. In these trials, the Company demonstrates successful treatment using BonoFill™ in cases where other treatments have failed or are not applicable.

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 will present the final results of a Phase II clinical trial to treat facial bone deficiencies on May 31, 2024, at the annual meeting of the International Society for Cell & Gene Therapy. 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 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. 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.

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.

Sincerely,

Bonus BioGroup Ltd.

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

References

  1. Mesenchymal Stem/Stromal Cells Oral Abstracts | Friday, May 31, 2024
  2. At the time of the report, the Company estimates that by May 31, 2024, the final results of a Phase II clinical trial to treat facial bone deficiencies will be analyzed.
  3. For more details, see Section 7.3.2 and Section 15 of Part A of the Company Annual Report for 2023, dated March 29, 2024 (reference 2024-01-034929), which is included in this report by reference.
  4. https://www.isctglobal.org/isct2024/program/full
  5. https://isctglobal.org/page/AboutUs
  6. For more details, see Immediate Report dated February 21, 2024 (reference: 2024-01-018204), which is included in this report by reference.
  7. For more details, see Immediate Report dated February 14, 2024 (reference: 2024-01-016023), which is included in this report by reference.
  8. For more details, see Immediate Report dated January 21, 2024 (reference: 2024-01-008406), which is included in this report by reference.
  9. For more details, see Section 14.1.14 of Part A of the Company Annual Report for 2023, dated March 29, 2024 (reference 2024-01-034929), which is included in this report by reference.
Last modified on Sunday, 19 May 2024 11:27

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