Novadip’s unique platform combines over 15 years of academic research with practical surgery experience and proof of principle clinical data to optimise efficacy and safety.
Novadip’s technology platform is a scaffold-free, 3-dimensional extracellular matrix, utilizing differentiated adipose-derived stem cells (ASCs), that mimics the physiology of natural healing to create a range of products based on growth factors, cells and their secretome to address specific challenges in tissue regeneration.
ASCs are easily harvested and have better osteogenic properties than bone marrow-derived stem cells. ASCs can be isolated from a fatty tissue sample collected via a simple subcutaneous procedure. At Novadip, ASCs are primed to restore functional tissue structure under proprietary quality controls.
The platform is based on a virtuous cycle that occurs between ASCs and the extracellular matrix (ECM) that develops after seeding the cells with active particles resulting in an ECM containing highly bioactive ASCs, with a highly specific secretome, and high and stable amounts of growth factors and specific proteins, which together have properties necessary to promote hard and soft tissue regeneration.
Novadip’s initial clinical stage product candidates are highly bioactive, malleable materials comprising ASCs and a complex ECM with the structural and functional characteristics to address large hard and soft tissue reconstruction.
The product candidates are easy for physicians to use and are readily integrated into current treatment paradigms, promising potentially better efficacy and tolerability than scaffold-based approaches as well as simplified manufacturing and lower regulatory barriers. The current product candidates are individualised for each patient to maximise potential for efficacy and minimize safety concerns.
Novadip has developed a robust manufacturing process and distribution platform for its autologous cell therapies.
Novadip’s cell therapy product candidates have been specifically designed for critical size hard and soft tissue reconstruction and are being developed for orphan bone and skin diseases with large unmet needs.
NVD-003 is a second-generation therapy for critical size bone reconstruction, which comprises bioactive ASCs in an ECM to result in the active local delivery of the secretome and growth factors, leading to biological activity necessary for tissue regeneration for large bone defects.
NVD-003 is malleable and 3-dimensional product candidate that is capable of filling large bone defects. It has been shown to promote osteogenesis and angiogenesis, with anti-osteoclastic and high mineralization properties, while maintaining the ability to function in a low oxygen environment.
The lead indication for NVD-003 is a rare paediatric orthopaedic disease in which the tibia of a young child breaks due to bowing and does not heal, resulting in non-union (congenital pseudarthrosis of the tibia or CPT). An initial trial in North America is planned to begin in 2020.
A Phase 1/2a trial in adults with a large bone non-healing fractures (bone non-union) is ongoing.
NVD-001 is a first-generation therapy for bone regeneration and is being tested in a controlled Phase 1/2a trial in single-level spinal fusion patients. The trial is fully enrolled.
NVD-SKIN is an autologous cell therapy for critical size skin repair. It is designed to have the key attributes of angiogenicity and dermis tissue remodelling to restore deep-thickness skin integrity and be used for large skin grafts.
Novadip’s unique technology platform is also generating allogeneic, ‘off-the-shelf’ product candidates to address prevalent indications in hard and soft tissue reconstruction.
These product candidates are intended to act via passive local delivery and be implantable into the tissue defect. They are being specifically designed to treat smaller and more common tissue defects.
NVD-AB1 is in preclinical development for hard tissue reconstruction.
NVD-AS1 is in preclinical development for soft tissue reconstruction.