Bone Biologics is a publicly traded company based in Burlington, MA and is focused on developing and marketing orthobiologic products. Our proprietary platform technology is NELL-1, a recombinant human protein growth factor that is essential for normal bone development. Our lead product is a NELL-1 based bone graft substitute for spine fusion, targeting the rapidly growing orthobiologics market. Our goal is to offer patients superior safety with uncompromising efficacy relative to existing technologies. NELL-1 provides specific targeted regulation over bone regeneration in the presence of targeted osteogenic cells, as both demonstrated in the lab and through the use of animal testing, unlike any other current therapy. It has been shown not to form bone when applied to non-osteogenic cells such as myoblasts (a type of embryonic progenitor cell that differentiates to give rise to muscle cells) nor does it induce adipogenesis (the formation of fat that can occur within the bone matrix often exhibited as cysts) that results in weaker bone.
Our mission is to utilize the power of NELL-1 to improve clinical outcomes and reduce total health care delivery costs associated with spinal fusion. Bone Biologics is focused on bone repair and regeneration applications and is committed to exploring additional applications of the NELL-1 technology to enhance bone regeneration and repair in areas where the current options provide suboptimal patient outcomes.
The Bone Biologics leadership team consists of some of the top leaders and innovators of orthobiologics in regenerative medicine. Not only does our leadership provide strategic oversight of the Company, they contribute to the collective advancement of the industry. This leadership is instrumental in fulfilling our mission to improve clinical outcomes and reduce health care delivery costs associated with lumbar spinal fusion.
While Bone Biologics has chosen to focus its initial product development efforts in spinal fusion, we believe that this regenerative medicine technology has potential in the broader fields of bone regeneration and repair including osteoporosis, chondrocytes and applications using mesenchymal stem cells.
Bone Biologics Reaches Major Preclinical Milestone In Regenerative Bone Material Development
30 June 2016
This article was originally published in Clinica.
Bone Biologics is poised to reach an important milestone in its long journey to develop its NELL-1 osteoinductive protein into a commercially viable product for spine surgery. The firm plans to start large animal studies in the second half of 2016.
NELL-1 is designed to stimulate ingrowth and proliferation of osteoblasts, the cells responsible for bone formation. Published research has demonstrated NELL-1 as a viable tool to form bone in targeted areas, suggesting it would be safer than other bone-growth factors and implanted devices, according to the company.
CEO Stephen La Neve told Clinica that feasibility data on NELL-1 from large animal studies will be available by around the middle of 2017. The Boston-based company will continue ramping-up animal testing in 2018 and hopes to start a first-in-man trial outside the US in 2019. In parallel, it is working with the US FDA on designing a US pivotal trial. The company expects to begin a first-in-man US clinical trial in 2020 and secure FDA approval for NELL-1 for two spine fusion indications – posterolateral fusions and transforaminal lumbar interbody fusions– by 2023.
In February, Bone Biologics completed a $5.75m funding round with the Musculoskeletal Transplant Foundation, OrthoFix Holdings, Inc. and Hankey Capital, LLC to fund further development and synthesis of NELL-1. The company has not yet raised enough money to take the product all the way through to the 2023 commercialization target, but believes it can get there. “Our strategy is to raise money to get us to the next milestone, and then we'll leverage that for another raise on top of that,” Jeff Frelick, the firm's chief operating officer, said. “This will be a stepwise function, paired with major milestones along the way.”
In 2006, Bone Biologics entered into an exclusive license agreement with the University of California – Los Angeles for the worldwide application of the NELL-1 protein through a technology transfer. Since then, Bone Biologics has been funding the development and formulation of NELL-1 as a bone graft substitute for bone regeneration in spinal fusion procedures under exclusive license from UCLA. And on June 17, the company announced that it completed an option agreement with UCLA giving it an opportunity to exclusively license NELL-1 to treat osteoporosis.
NELL-1 has been produced on a small scale using Chinese hamster ovary cells, but, since 2015, Bone Biologics has been working with contract manufacturing organizations in the US to scale-up manufacturing and bring the production under Current Good Manufacturing Practices, La Neve said.
Targeting The Spine
La Neve explained that development of NELL-1 began about 20 years ago with investigations of craniosynostosis, a condition in which fibrous sutures of an infant’s skull prematurely fuse by turning into bone. Researchers isolated and identified the molecule that was overexpressed in patients with craniosynostosis, and used that knowledge to create NELL-1.
NELL-1’s mechanism of action avoids unwanted bone formation in surrounding tissue by only growing bone in the presence of bone, so it is ideal for targeted applications, the company says. Based on the lab and animal testing, researchers expect NELL-1 to produce minimal post-operative side-effects.
La Neve said the company is initially focused on using NELL-1 in “hard to heal” patients undergoing posterolateral fusions and transforaminal lumbar interbody fusions. The hard-to-heal group includes smokers, diabetics, the obese, and those with osteoporosis. The company is optimistic that NELL-1 will speed-up healing and improve the strength of fusion in these patients.
Frelick, the firm's COO, told Clinica that NELL-1 may eventually be applicable to multiple orthopedic indications, but the company is focusing on spinal fusion first because it is by far the largest opportunity for osteoinductive proteins. He said spine procedures account for about $10bn of the $55bn annual orthopedics market.
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