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Bone Therapeutics signs research partnership with Implant Therapeutics to access induced Pluripotent Stem Cells (iPSC)

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REGULATED INFORMATION


Bone Therapeutics will gain access to iPS cell lines, including hypoimmunogenic cell lines, differentiation protocols and expertise

iPSC technology allows for the development of next-generation cell therapy products as a key addition to Bone Therapeutic’s existing cell therapy platform


Gosselies, Belgium and Beltsville, MA, US, 28 September 2021, 7.00 am CEST – BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the cell therapy company addressing unmet medical needs in orthopedics and other diseases, and IMPLANT THERAPEUTICS, the developer of hypoimmunogenic and safe harbor engineered IPSC derived cells, today announced the signing of a research evaluation agreement. The agreement will enable Bone Therapeutics to access, evaluate and materially transfer Implant Therapeutics’ Induced Pluripotent Stem Cell (iPSC) lines, media, differentiation protocols and expertise.

Bone Therapeutics has developed a cutting-edge bone marrow-derived off-the-shelf, allogeneic MSC cell therapy platform. Its allogeneic cell therapy product, ALLOB, currently in clinical trials for different orthopedic indications, has resulted from this platform. Bone Therapeutics is now utilizing its expertise to broader clinical indications of high unmet medical need as previously communicated. To achieve this strategic aim, it is now expanding its sources of MSCs from those derived from bone marrow and implementing genetic modification of MSCs to achieve higher therapeutic efficacy.

Bone Therapeutics has partnered with Implant Therapeutics to gain access to iPSC derived, genetically engineered MSCs. These specific single source MSCs are highly standardized, are expandable and scalable. They are also more flexible with regards to modification methodologies, including gene editing and transduction, than existing autologous and allogeneic approaches. This specific agreement is set to last twelve months, and be focused on achieving early-stage research and product design and testing. Bone Therapeutics will initially perform technology evaluation, product design and optimization of these iPSC derived MSCs. Bone Therapeutics and Implant Therapeutics will discuss an agreement covering commercial R&D and commercialization stages of development as required.

Bone Therapeutics will, in parallel, continue to research and evaluate a number of genes that are of interest as well as genetic modification technologies and methodologies. This separate activity will be undertaken to enhance the functionality and efficacy of MSCs for specific indications.

“Unmodified MSC-based products have already generated positive efficacy signals across the industry. Bone Therapeutics believes that greater efficacy can be further achieved by professionalizing and tailoring the functionality of the cells for each indication, as Bone Therapeutics has already achieved for ALLOB,” said Tony Ting, CSO, Bone Therapeutics. “To address further, life-threatening indications with high levels of mortality and a significant unmet medical need, it will be essential to genetically engineer MSCs. This will give these cells the ammunition they need to tackle difficult diseases. The agreement with Implant Therapeutics allows Bone Therapeutics to access specific and advantageous iPSC derived MSCs and utilize its iPSC expertise, including that of Mahendra Rao, a renowned world-class expert in the field. His expertise, knowhow and support are highly valuable components and a key motivation behind this collaboration.”

“Implant Therapeutics has acquired technologies and considerable specialist knowledge to build our portfolio of iPSC derived MSCs. This expertise will be of specific use to Bone Therapeutics as it utilises our iPSC derived MSCs to expand its indications,” said Dr. Mahendra Rao, founder, Implant Therapeutics. “We will continue to work with Bone Therapeutics as it develops and integrates these iPSC derived MSCs to address significant unmet medical needs.”


About Implant Therapeutics
Implant provides hypoimmunogenic and safe harbor engineered IPSC derived cells in order to deliver the ultimate therapeutic MSC products. To learn more, visit https://www.implant-rx.com/


About Bone Therapeutics

Bone Therapeutics is a leading biotech company focused on the development of innovative products to address high unmet needs in orthopedics and other diseases. The Company has a diversified portfolio of cell therapies at different stages ranging from pre-clinical programs in immunomodulation to mid stage clinical development for orthopedic conditions, targeting markets with large unmet medical needs and limited innovation.

Bone Therapeutics’ core technology is based on its cutting-edge allogeneic cell and gene therapy platform with differentiated bone marrow sourced Mesenchymal Stromal Cells (MSCs) which can be stored at the point of use in the hospital. Currently in pre-clinical development, BT-20, the most recent product candidate from this technology, targets inflammatory conditions, while the leading investigational medicinal product, ALLOB, represents a unique, proprietary approach to bone regeneration, which turns undifferentiated stromal cells from healthy donors into bone-forming cells. These cells are produced via the Bone Therapeutics’ scalable manufacturing process. Following the CTA approval by regulatory authorities in Europe, the Company has initiated patient recruitment for the Phase IIb clinical trial with ALLOB in patients with difficult tibial fractures, using its optimized production process. ALLOB continues to be evaluated for other orthopedic indications including spinal fusion, osteotomy, maxillofacial and dental.

Bone Therapeutics’ cell therapy products are manufactured to the highest GMP (Good Manufacturing Practices) standards and are protected by a broad IP (Intellectual Property) portfolio covering ten patent families as well as knowhow. The Company is based in the BioPark in Gosselies, Belgium. Further information is available at www.bonetherapeutics.com.


For further Implant Therapeutics information, please contact:

Implant Therapeutics
Lisa Schummer, Manager Operations
Tel: +1 (888)-613-6862
lisa@pancella.com


For further information, please contact:

Bone Therapeutics SA
Miguel Forte, MD, PhD, Chief Executive Officer
Lieve Creten, Chief Financial Officer ad interim
Tel: +32 (0)71 12 10 00
investorrelations@bonetherapeutics.com

For Belgian Media and Investor Enquiries:
Bepublic
Catherine Haquenne
Tel: +32 (0)497 75 63 56
catherine@bepublic.be

International Media Enquiries:
Image Box Communications
Neil Hunter / Michelle Boxall
Tel: +44 (0)20 8943 4685
neil.hunter@ibcomms.agency / michelle@ibcomms.agency

For French Media and Investor Enquiries:
NewCap Investor Relations & Financial Communications
Pierre Laurent, Louis-Victor Delouvrier and Arthur Rouillé
Tel: +33 (0)1 44 71 94 94
bone@newcap.eu


Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors’ current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.


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