Bone Therapeutics and Kasios Form Product Development Partnership

Bone Therapeutics and Kasios, a specialist in synthetic bone substitutes, have entered a two-year collaboration to develop a novel product for spinal fusion procedures.

The collaboration combines Bone Therapeutics’ allogeneic osteoblastic cell therapy product called Allob with Kasios’s synthetic micro-granules bone substitute. The project is subsidized by the Government of the Walloon Region of Belgium. Bone Therapeutics is headquartered in Gosselies (south of Brussels), Belgium.

Bone Therapeutics is a biotechnology company specializing in the development of regenerative therapies for the treatment of orthopedic conditions. The products under development contain regenerative osteoblastic/bone forming cells, administrable through a minimally invasive percutaneous technique.

Officials from 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:

• 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”;
• Osteogenesis, the production of new bone.

According to Bone Therapeutics officials, Allob already has 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 osteoconductive micro-granules has the potential to enhance 3-D growth and bone growth in spine fusion, bringing advantages in stability and structure, officials noted. Osteoconduction is particularly key in spine fusion procedures, where larger fracture areas create a need for more structural support.

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, according to the companies.

“We are excited by the collaboration with Kasios which positions both companies at the forefront of development into an innovative new approach to spine fusion,” said Enrico Bastianelli, CEO of Bone Therapeutics. “Kasios is a leader in synthetic bone substitutes and we look forward to what we hope will be a very fruitful collaboration as we seek to advance novel solutions for spine fusion.”

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. 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. The product, according to the company, also has the potential to be administered systemically to treat orthopedic conditions such as osteogenesis imperfecta, a rare genetic bone disease characterized by bone fragility and fractures.

Preob, Bone Therapeutics’ autologous cell product, currently is in pivotal Phase III clinical studies for two indications: osteonecrosis and non-union fractures, and in Phase II for treatment resistant osteoporosis.

Kasios specializes in the development, manufacture and commercialization of synthetic bone substitutes for use in orthopedics, spine and dental surgery. Founded in 2001, Kasios is headquartered in Gilly, Belgium, and L’Union, France.

New Regulatory Officer
Bone Therapeutics has appointed Guy Heynen, M.D., as chief clinical and regulatory officer. Heynen will support Bone Therapeutics as it advances its portfolio of regenerative bone disease and orthopedic therapies through clinical development towards commercialization.

Heynen is a specialist in rheumatology and immunology, with extensive experience both in university medical practice and in the pharmaceutical industry. He has more than 35 years of experience in medical and regulatory affairs at local, regional and international levels and has a particular focus on management, team building and leadership. The majority of his career has been with Pfizer Inc., where he held a number of senior roles including medical director for Pfizer Switzerland, European team leader for the Alzheimer’s disease drug Aricept, and medical team leader for Pfizer’s anti-inflammatory drug franchise based in New York, N.Y.

“I am privileged to be joining the company at such an exciting time in its development and I look forward to working with the team to advance its innovative products towards commercialization,” Heynen said.

Heynen also serves on the boards of Euroscreen SA, Progenosis SA and as an advisor for Promethera Biosciences, roles that highlight his expertise and network in cell therapy. Heynen remains a regional medical monitor for Pfizer GmbH.

Heynen began his career at the Belgian National Foundation for Research and in research roles at University Hospital in Liege, Belgium, where he received his degree in medicine and rheumatology.

“Guy Heynen has a distinguished track record both in hospital medical practice and industry. His understanding of clinical operations and regulatory affairs will be an invaluable asset to Bone Therapeutics as we move forward to advance our late-stage pipeline of regenerative medicines in bone diseases and orthopedics,” said Bastianelli. “His long-standing experience within major pharmaceutical companies around the world will be key in preparing to bring our products to market and supporting Bone Therapeutics’ development on a global scale. Dr. Heynen’s experience advising cell therapy companies also provides important understanding of this growing sector.”