Bone Therapeutics and its collaborators Cerhum, 3D-Side, mSKIL and IREC awarded €3 million in funding under the framework of BioWin, the health cluster of Wallonia, to develop personalized, tissue engineered bone implants

Gosselies, Belgium, 10 November 2020, 7am CET – BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the cell therapy company addressing unmet medical needs in orthopedics and other diseases, Cerhum, 3D-Side, mSKIL and IREC, today announce the start of a new research collaboration with expert industry and academic partners. The collaboration has been formed to develop biologically active, patient-tailored, 3D printed, bioresorbable implants enriched with Bone Therapeutics’ allogeneic bone forming cells, ALLOB. The consortium has been established under the “Competitiveness Clusters” framework of the Walloon Health Association, BioWin. The consortium has received €3 million non-dilutive funding, granted by Minister Willy Borsus, Vice-President of Wallonia, Belgium and Minister of Economy, Research and Innovation, Digital Technology, Agriculture and Regional Planning and approved by the Walloon Government. The granting of the funding is subject to conditions precedent.

This 28-months collaboration is called TrueBone3D and aims to develop biologically active, custom-made tissue engineered bone implants that could replace bone transplants harvested from patient’s own bones (autografts). Autograft is the current standard treatment in bone reconstruction surgeries. However, harvestable autograft bone is only available in limited supply. This also requires an additional painful surgery. The current treatments are commonly associated with complications such as graft site infection and fracture, increased bleeding, nerve damage and reduced mobility. In addition, it is difficult to precisely shape autografts to fit the bone defect.

TrueBone3D’s patient-specific, 3D printed scaffold of the new tissue engineered bone implant will be designed to accurately match the missing bone part. The use of bioresorbable material will allow the implant to integrate with the surrounding bone tissue and to be gradually replaced by newly formed, healthy bone. By combining the tailored scaffold with Bone Therapeutics’ differentiated bone forming cells, ALLOB, the enhanced tissue engineered product is expected to exhibit strong bone-forming activities and stimulate bone regeneration. The aim of the resultant TrueBone3D’s cell-enriched implant is to form a safe and structurally superior alternative to bone autografts. The final goal of the project is to evaluate the safety and efficacy of the new personalized, tissue engineered bone implants as treatment option for non-union fractures in a proof-of-concept clinical study.

The research partnership consortium has been specifically created to benefit from the complementary expertise of the specialized industry and academic partners for the development of the next generation of personalized, tissue engineered bone implants. 3D-Side, an expert in 3D software for patient specific medical devices, will develop the platform to plan the surgery and to determine the bone defect based on patient’s CT scan images. Cerhum, specialized in bone 3D printing and coordinator of the TrueBone3D project, will use the 3D computer model of the bone defect to manufacture a patient-tailored resorbable implant. Bone Therapeutics’ bone-forming cells will be added during the surgical procedure. The academic research centers, musculoSKeletal Innovative research Lab (mSKIL) of University of Liège, Belgium, and IREC (Institute of Experimental and Clinical Research) of Université catholique de Louvain, Belgium, will investigate the biocompatibility and bioactivity of the newly developed tissue engineered bone implants in in-vitro and in-vivo models.

“The TrueBone3D consortium will enable Bone Therapeutics to share its expertise in bone regeneration and, through collaborative activity, broaden the application of its allogeneic cell therapy platform, ALLOB, to other orthopedic conditions, including large bone defects, cranial and maxillo-facial reconstruction surgeries,” said Miguel Forte, MD, PhD, Chief Executive Officer of Bone Therapeutics. “Currently, for these conditions, grafts from patients’ own bone tissue are mostly used to repair the bone defects. This treatment is often associated with a range of serious complications. Bone Therapeutics, by joining forces with industry and academic experts, continues to pioneer the use of cell therapy in bone regeneration and develop potentially safer and effective treatment options that could be fully tailored to the need of the patient.”

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 and biologic therapies at different stages ranging from pre-clinical programs in immunomodulation to mid-to-late stage clinical development for orthopedic conditions, targeting markets with large unmet medical needs and limited innovation.

Bone Therapeutics is developing an off-the-shelf next-generation improved viscosupplement, JTA-004, which is currently in Phase III development for the treatment of pain in knee osteoarthritis. Consisting of a unique combination of plasma proteins, hyaluronic acid - a natural component of knee synovial fluid, and a fast-acting analgesic, JTA-004 intends to provide added lubrication and protection to the cartilage of the arthritic joint and to alleviate osteoarthritic pain and inflammation. Positive Phase IIb efficacy results in patients with knee osteoarthritis showed a statistically significant improvement in pain relief compared to a leading viscosupplement.

Bone Therapeutics’ core technology is based on its cutting-edge allogeneic cell 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 is ready to start 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 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 .

For further information, please contact:

Bone Therapeutics SA

Miguel Forte, MD, PhD, Chief Executive Officer

Jean-Luc Vandebroek, Chief Financial Officer

Tel: +32 (0)71 12 10 00

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Catherine Haquenne

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