Date: 2014-11-17
Type of information: Development agreement
Compound: novel product for spinal fusion procedures based on the combination of allogeneic osteoblastic cell therapy product ALLOB® with Kasios’s synthetic micro-granules bone substitute
Company: Bone Therapeutics (Belgium) Kasios (France)
Therapeutic area: Bone diseases
Type agreement: development
Action mechanism: ALLOB® is a first-in-class allogeneic osteoblastic cell product with regenerative properties, developed for the treatment of bone diseases. \"Allogeneic\" means that the cells are harvested from a healthy, universal donor, as opposed to “autologous” where the cells come from the patient him/herself. ALLOB® is currently tested in two Phase I/IIa clinical trials for the treatment of delayed union fractures and lumbar fusion for degenerative disease of the spine. ALLOB® also has the potential to be administered systemically to treat orthopaedic conditions such as osteogenesis imperfecta, a rare genetic bone disease characterized by bone fragility and fractures. ALLOB® has been classified as a tissue engineered product under the ATMP regulation 1394/2007EMA.
Disease: spinal fusion
Details: * On November 17, 2014, Bone Therapeutics, a regenerative therapy company addressing unmet medical needs in the fields of bone diseases and orthopaedics and Kasios, a synthetic bone substitute specialist, announced a two-year collaboration to develop a novel product for spinal fusion procedures. The collaboration combines Bone Therapeutics’ allogeneic osteoblastic cell therapy product ALLOB® with Kasios’s synthetic micro-granules bone substitute. The project is subsidized by the Government of the Walloon Region.
Bone Therapeutics and Kasios believe the combined product offering will create a novel approach to spine fusion, where previous methods have failed to provide the three essential properties required for bone formation in this specific indication: osteoconduction, when bone graft material serves as a support for new bone growth; osteoinduction, in which immature cells are recruited and stimulated to develop into bone-forming cells or “osteoblasts” and osteogenesis, the production of new bone. Bone Therapeutics’ allogeneic osteoblastic cell therapy product ALLOB® has already shown bone forming properties including osteoinduction and osteogenicity, as well as excellent safety and efficacy in preclinical studies.
Combining Bone Therapeutics’ ALLOB® cells with Kasios®TCP’s osteoconductive micro-granules has the potential to enhance 3D growth and bone growth in spine fusion, bringing advantages in stability and structure. Osteoconduction is particularly key in spine fusion procedures, where larger fracture areas create a need for more structural support, which Kasios’ micro-granules can provide.
A number of methods have been developed and proposed to promote spinal fusion, such as ceramics, cadaver bones, osteoinductive growth factors or undifferentiated stem cells. However, non-union of bone and persistent pain following spinal fusion intervention is still common so further improvements in the procedure that improve safety and efficacy are still strongly needed.
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