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Thursday, 14 November 2024 19:55

Bonus Biogroup Presents at the Advanced Therapies Conference USA 2024: Two-Fold Success: Enhancing Patient Care Efficiency While Reducing Costs Compared to Alternative Treatments

Bonus Biogroup is pleased to announce that it was invited to present its pioneering approach to developing advanced, safe, and effective treatments for complex medical conditions with unmet clinical needs[1]. This presentation was part of a session on clinical trials and development held on January 13, 2024, at the Advanced Therapies Conference USA 2024[2], from November 12-13, 2024, in Philadelphia, USA.

Bonus Biogroup demonstrated dual success in developing advanced therapies, reflected in significant improvements in patient care and generating treatments at an industrial scale under Good Manufacturing Practices (GMP) while maintaining costs below alternative solutions within the inferior standard of care.

These achievements align with the Company's mission to create advanced therapies that are safe and highly effective without compromising on affordability and accessibility to a broad patient population.

Furthermore, the conference organizers selected Dr. Tomer Bronshtein, VP of Innovation and Corporate Development at Bonus Biogroup, to lead a special session highlighting the benefits and challenges associated with the development, manufacturing, and commercialization of advanced autologous and allogeneic therapies. Autologous therapies are based on live cells extracted from the patient and include, for example, BonoFill™—a live human bone graft developed by the Company to treat bone deficiencies. The session also covered advanced allogeneic therapies utilizing living cells derived from a healthy donor, such as MesenCure™—a cell therapy drug developed by the Company to treat inflammation and tissue damage.

The Advanced Therapies Conference USA serves as a global platform for cell and gene therapy companies to showcase advanced therapies and innovative products currently in the late stages of development. It attracts pharmaceutical, biopharmaceutical, and biotechnology companies and investors from around the world.

Dr. Shai Meretzki, CEO of Bonus Biogroup, stated: "We are proud to have the opportunity to present Bonus Biogroup's breakthroughs at the Advanced Therapies Conference USA. These innovations have enabled us to develop novel, safe, and effective treatments for complex and prevalent medical conditions designed to improve the quality of life for millions of patients worldwide. We thank the conference organizers for counting us among the leading companies in the advanced therapies field and inviting us to present in the conference sessions."

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-nine approved patents and eleven 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™. 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™[3]. 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.

Sincerely,

Bonus Biogroup Ltd.

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

 

[1] Revolutionizing Regenerative Medicine: BonoFill™ and MesenCure™ - Pioneering Accessible and Economical Advanced Therapies at Bonus Biogroup

[2] Advanced Therapies USA 2024; https://www.terrapinn.com/congress/advanced-therapies-usa/

[3] 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).

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