Novadip Biosciences reports positive data from phase I study of NVD-001 for spinal fusion

Novadip Biosciences reports positive data from phase I study of NVD-001 for spinal fusion

• Primary endpoint met, study validates autologous cell therapy 3M³ platform for bone regeneration and demonstrates manufacturing capabilities
  
  
• Next generation autologous product NVD-003 to be advanced in clinical development
  
  

Mont-Saint-Guibert, June 15, 2021 - Novadip Biosciences (“Novadip”), a clinical stage company developing treatments to regenerate impaired tissues in patients with significant unmet medical needs, today announced positive final results from a Phase I study of its autologous cell-based product, NVD-001, in patients needing single-level spinal fusion.

NVD-001 is Novadip’s first generation autologous cell-based osteogenic (bone healing) product derived from the Company’s proprietary tissue regeneration platform. The Phase 1 trial evaluated NVD-001 safety and preliminary effectiveness for the treatment of low grade degenerative lumbar spondylolysthesis.

Dr. Denis Dufrane (MD, PhD), Chief Executive Officer and Founder, said: “The results of this study highlight the excellent safety profile of our autologous prototype product NVD-001 whilst demonstrating clear evidence of its bone regeneration potential. As we progress our development candidate, NVD-003, we are encouraged by these results which validate our proprietary cell therapy 3M³ platform. By mimicking the process of natural healing, our 3M³ platform technology can deliver extraordinary outcomes for patients. We are excited to further progressing NVD-003 with interim efficacy data in bone non-union expected later this year.”

Prof. Gunnar Anderson (MD, PhD), Professor and Chairman Emeritus of the Department of Orthopedic Surgery at Rush University Medical Center, Chicago and Chairman of the Scientific Advisory Board of Novadip commented: "The results of this study clearly demonstrate the safety of Novadip’s 3-dimensional autologous adipose-derived bone product. The study was not powered to show differences between groups but is hugely encouraging with excellent bone formation. Based on this data, the development candidate, NVD-003, has the potential to become the solution for both patients undergoing spinal fusion and those with large bone defects where there is currently an unmet need.”

The trial is a prospective multi-center, randomized, controlled study to evaluate the safety and preliminary effectiveness of NVD-001 for the treatment of low grade degenerative lumbar spondylolisthesis by interbody fusion of one vertebral segment. The study consists of a 12-month initial follow-up period post-surgery and a subsequent 12-month long term follow-up.

The study included 32 patients in total, of whom 23 were NVD-001 patients with the remaining nine being standard of care patients from centers in Belgium, Poland and the Czech Republic.

The key findings from the trial were as follows:

• The primary endpoint of safety was met. NVD-001 demonstrated a favorable safety profile over a two-year observation period.
• NVD-001 did not require additional surgical time without autologous bone harvesting and did not prolong the time spent in hospital. 
• NVD-001 demonstrated beneficial effects on the quality of life of patients with reduction of pain and increase of walking capacity.
• NVD-001 demonstrated proof of concept of osteogenesis and osteoinduction in the intervertebral body space, which is known to be a challenging environment for bone formation. 
• NVD-001 was manufactured with 100% of success and delivered on time for all patients included in the trial.
  
  

Pr. Christian Raftopoulos (MD, PhD), Principal investigator of the trial, Head of Neurosurgery Department, University hospital Saint-Luc, said: "As the neurosurgeon responsible for implanting NVD-001, I was hugely impressed by the ease of use of this product. It was well integrated into the surgical procedure with favorable safety outcomes and promising demonstration of osteoinduction."​

With this further validation of its autologous platform, Novadip will now focus on its next-generation program, NVD-003. The product is currently in clinical development for bone non-union and expects to report 12 month follow up data later this year. The Company NVD-003 was granted Orphan Drug designation and Rare Paediatric Disease designation by the US Food and Drug Administration (FDA) in 2021 for congenital pseudarthrosis of the tibia (“CPT”), a rare debilitating condition which mainly affects children.

Notes to editors

About Novadip Biosciences

Novadip Biosciences is a clinical stage biopharmaceutical company leveraging its proprietary tissue regeneration technology platform 3M³ to generate multiple product candidates to address tissue reconstruction for patients who have limited or no treatment options. The 3M³ platform involves use of 3-dimensional extracellular matrix and adipose-derived stem cells to deliver highly specific growth factors and miRNAs to mimic the physiology of natural healing to create a range of products that address specific challenges in tissue regeneration. Novadip’s initial focus is on reconstruction of critical size bone defects. The company is also applying its 3M³ platform to develop truly novel off-the-shelf/allogeneic therapies addressing more prevalent tissue defects and miRNA/exosome products for broader indications.

About NVD-001

NVD-001, Novadip’s first autologous product, is a clinical-stage investigational cell-based therapy, which represents a new paradigm in regenerative medicine. NVD-001 is an autologous cellular medicinal product obtained by the culture of adipose tissue, which leads to osteogenic cells after ex vivo isolation, expansion and differentiation of pluripotent adipose-tissue stem cells (ASC), and combination with an allogeneic fully demineralized bone matrix into a 3D bone implant. Upon implantation, the bone-forming cells protected in their self-secreted matrix from the harsh pathological environment in the bone defect continue to mature and progressively transform the putty into normal, healthy bone.

About NVD-003

NVD-003 is the new generation of Novadip’s autologous product. For the physician, the product is in the form of a mouldable putty in quantities large enough to fill small as well as large bone defects (>20cm³) using classical or minimally invasive surgery techniques without further complexities. Using its proprietary 3M³ technology, stem cells from the patient obtained from only a few millilitres of fatty tissue are cultured in vitro to become a biomaterial consisting of bone forming cells embedded in their self-secreted extracellular matrix together with added hydroxyapatite particles, a mineral naturally present in bone to confer initial strength. The product is, therefore, more mineralized than NVD-001 which enables a faster bone formation. NVD-003 was granted Orphan Drug designation and Rare Paediatric Disease designation by the US Food and Drug Administration (FDA) in December 2021.

Attachments

• Integration of NVD-001 in intervertebral body cage fusion
• NVD-001 Product